S.I. No. 261/2021 - Medical Devices Regulations 2021


Notice of the making of this Statutory Instrument was published in

“Iris Oifigiúil” of 28th May, 2021.

I, STEPHEN DONNELLY, Minister for Health, in exercise of the powers conferred on me by section 32 (as amended by section 16 of the Irish Medicines Board (Miscellaneous Provisions) Act 2006 (No. 3 of 2006) of the Irish Medicines Board Act 1995 (No. 29 of 1995) and for the purpose of giving full effect to Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 20171 , Regulation (EU) 2020/561 of the European Parliament and of the Council of 23 April 20202 , Regulation (EC) No. 765/2008 of the European Parliament and of the Council of 9 July 20083 and Regulation (EU) 2019/1020 of the European Parliament and of the Council of 20 June 20194 , hereby make the following regulations:

PART 1

PRELIMINARY

Citation

1. These Regulations may be cited as the Medical Devices Regulations 2021.

Commencement

2. These Regulations come into operation on 26 May 2021.

Interpretation

3. (1) In these Regulations—

“approved examiner” means—

(a) a Chief Medical Scientist located at an official laboratory,

(b) a Consultant Microbiologist located at an official laboratory,

(c) a Deputy Public Analyst located at a Public Analyst’s Laboratory,

(d) an Executive Analytical Chemist located at a Public Analyst’s Laboratory,

(e) a Public Analyst located at a Public Analyst’s Laboratory, or

(f) a person, or member of a class of persons, designated for that purpose by the Authority;

“authorised officer” means—

(a) a person appointed under Regulation 28, or

(b) an officer of Customs and Excise;

“Authority” means the Health Products Regulatory Authority;

“combination product” means a medical device excluded from the general application of the EU Regulation pursuant to Article 1(8) (second subparagraph), (9) or (10) thereof;

“compliance notice” mean a notice under Regulation 32;

“device” means—

(a) a medical device,

(b) an accessory for a medical device, or

(c) a product listed in Annex XVI to the EU Regulation to which the EU Regulation applies pursuant to Article 1(2) thereof,

and does not include—

(i) a product or other substance excluded by Article 1(6) of the EU Regulation,

(ii) a combination product, or

(iii) an in-house device;

“EU Regulation” means Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 20171 , as amended by Regulation (EU) 2020/561 of the European Parliament and of the Council of 23 April 20202 ;

“information society service” has the meaning assigned to it by point (b) of Article 1(1) of Directive (EU) 2015/1535 of the European Parliament and of the Council of 9 September 20155 ;

“in-house device” means a medical device which—

(a) is manufactured and used only within a health institution,

(b) complies with all of the conditions in Article 5(5) of the EU Regulation, and

is not manufactured on an industrial scale;

“inspect” includes search;

“Market Surveillance Regulation” means Regulation (EU) 2019/1020 of the European Parliament and of the Council of 20 June 20194 ;

“member state” means—

(a) a member state of the European Economic Area, or

(b) Switzerland;

“Minister” means the Minister for Health;

“National REC” means a National Research Ethics Committee for Clinical Investigations of Medical Devices

“official laboratory” means—

(a) the Public Analyst’s Laboratory, Cork,

(b) the Public Analyst’s Laboratory, Dublin,

(c) the Public Analyst’s Laboratory, Galway,

(d) a laboratory designated by the Authority for the purposes of the EU Regulation, or

(e) a laboratory designated for the purposes of the EU Regulation in another member state;

“online interface” means any software, including a website, part of a website or an application, that is operated by or on behalf of an economic operator, and which serves to give end users access to the economic operator’s products;

“person responsible for regulatory compliance” means any natural person who meets the requirements set out in Article 15(1) of the EU Regulation;

“premises” means any place (physical or virtual), ship or other vessel, aircraft, railway wagon or other vehicle or other mobile facility, and includes a container used to transport a medical device or other relevant thing;

“prohibition order” means an order under Regulation 33;

“quarantine notice” means a notice under Regulation 31;

“record” includes, in addition to a record in writing—

(a) a disc, tape, sound-track or other device in which information, sounds or signals are embodied so as to be capable, with or without the aid or some other instrument, of being reproduced in legible or audible form,

(b) a film, tape or other device in which visual images are embodied so as to be capable, with or without the aid or some other instrument, of being reproduced in visual form,

(c) a photograph, and

(d) a digital record,

and any reference to a copy of a record includes—

(i) in the case of a record to which subparagraph (a) of this definition applies, a transcript of the sounds or signals embodied therein,

(ii) in the case of a record to which subparagraph (b) of this definition applies, a still reproduction of the images embodied therein, and

(iii) in the case of a record to which subparagraphs (a) and (b) of this definition apply, such a transcript together with such a still reproduction;

“Regulations of 1994” means the European Communities (Medical Devices) Regulations 1994 ( S.I. No. 252 of 1994 );

“relevant thing” means—

(a) a device,

(b) a combination product,

(c) an in-house device,

(d) any article or substance used in the manufacture, processing, packaging, labelling, preparation, storage, distribution or advertising of a device or product referred to in subparagraph (a), (b) or (c); or

(e) another product being used, or purporting to be used, for medical purpose;

“supply by mail order” means any supply made, after solicitation of custom by the supplier, or by another person in the chain of supply whether inside or outside of the State, without the supplier and the customer being simultaneously present and using a means of communication at a distance, whether written or electronic, to convey the custom solicitation and the order for supply.

(2) A word or expression which is used in these Regulations and which is also used in the EU Regulation has, unless the context otherwise requires, the same meaning in these Regulations as it has in the EU Regulation.

Additional functions of Authority

4. (1) In addition to the functions conferred on the Authority by Regulation 3 of the European Union (Medical Devices and In Vitro Diagnostic Medical Devices) Regulations 2017 (S.I. No. 547 of 2017), the functions of the State referred to in Articles 4, 5(5), 6(4), 15(1)(a), 15(6)(a), 21(3), 40(1), 42, 44(12), 47(2), 47(4), 51(3), 59(3), 62(4)(a), 62(6), 70, 71(2), (3) and (4), 72(5), 73, 74, 75, 76, 77, 78, 80, 89(2), 90, 95, 96, 98, 100, 102(2), 106(11), 109(3), 109(4), and 110 of the EU Regulation shall be performed by the Authority.

(2) The Authority is designated as the market surveillance authority for medical devices for the purposes of Regulation (EC) No. 765/2008 of the European Parliament and of the Council of 9 July 20083 and the Market Surveillance Regulation.

Co-operation and exchange of information

5. (1) With the objective of performing its functions under these Regulations and the EU Regulation, the Authority may cooperate, as appropriate, with Departments of State, agencies and bodies having, by law, responsibility for any matter relating to any aspect of those functions.

(2) For the purpose of performing its functions under these Regulations and the EU Regulation, the Authority may exchange information, including personal data, to the extent that it is necessary and appropriate, with relevant public authorities only for the purpose of performing their functions, including the following bodies:

(a) the Garda Síochána;

(b) the Revenue Commissioners;

(c) Sport Ireland;

(d) the Health Service Executive;

(e) the Pharmaceutical Society of Ireland;

(f) the Medical Council;

(g) the Dental Council;

(h) the Nursing and Midwifery Board;

(i) the Department of Health;

(j) the Department of Employment Affairs and Social Protection;

(k) the Environmental Protection Agency (EPA);

(l) the Competition and Consumer Protection Commission (CCPC);

(m) the Department of, Enterprise, Trade and Employment.

(n) the Health Information and Quality Authority (HIQA);

(o) local authorities;

(p) competent authorities outside the State; and

(q) European Union bodies.

PART 2

IMPLANTABLE DEVICES AND SINGLE-USE DEVICES

Implant card and supply of information re. implanted device

6. A health institution shall make available to a patient who has been implanted with an implantable device by the health institution—

(a) the information referred to in Article 18(1) of the EU Regulation, by electronic, written or other appropriate means, and

(b) the implant card, which shall bear the patient’s identity,

as soon as possible, but no later than 30 working days after the implantation of the device.

Reprocessing and further use of single-use devices

7. (1) A person shall not reprocess a single-use device to make it suitable for further use in a member state unless there is compliance with Article 17(6), (7) and (8) of the EU Regulation.

(2) A person who reprocesses a single-use device pursuant to paragraph (1) shall—

(a) assume the obligations incumbent on manufacturers laid down in the EU Regulation, including obligations relating to the traceability of the reprocessed device in accordance with Chapter III of the EU Regulation, and

(b) be considered to be a producer for the purpose of Article 3(1) of Council Directive 85/374/EEC of 25 July 19856 .

PART 3

CLINICAL INVESTIGATIONS

Persons entitled to provide medical care to subjects

8. For the purposes of Article 62(4)(j) of the EU Regulation, the following persons are entitled to provide medical care to subjects of clinical investigations, as appropriate:

(a) a registered medical practitioner;

(b) a registered dentist;

(c) a registered nurse or midwife,

(d) a person registered in the Register of Pharmacists established under section 13(1) of the Pharmacy Act 2007 (No. 20 of 2007);

(e) a person registered in the Register of Optometrists established and maintained by the Optical Registration Board under section 36 of the Health and Social Care Professionals Act 2005 (No. 27 of 2005);

(f) a person registered in another register maintained under the Health and Social Care Professionals Act 2005 for the purpose of providing services for or in connection with the prevention, diagnosis or treatment of human illness.

Qualifications of investigators

9. For the purposes of Article 62(6) of the EU Regulation, the investigator shall be a person of appropriate education, training and experience to assume responsibility for the proper conduct of the clinical investigation, as determined by the sponsor, and such determination shall be subject to review by the Authority as part of its assessment of the clinical investigation application.

Qualifications of persons carrying out prior interviews

10. For the purposes of Article 63(2)(c) of the EU Regulation, the following persons are deemed to be appropriately qualified to carry out prior interviews with subjects, or, where the subject is not able to give informed consent, his or her legal representative for the purpose of obtaining his or her informed consent, as appropriate to the purpose of the clinical investigation:

(a) a registered medical practitioner;

(b) a registered dentist;

(c) a person referred to in Regulation 8(c), (d), (e) or (f), whose training, experience and qualifications have been assessed by the principal investigator and determined to be appropriate to qualify him or her to conduct the interview.

Submission of opinion of national research ethics committee opinion

11. A sponsor of a clinical investigation being conducted in the State shall submit to the Authority a copy of the opinion or opinions of a National REC in respect of the clinical investigation—

(a) where it is available at the time of the application for an authorisation or notification, at that time, or

(b) as soon as a copy is available thereafter.

Co-ordination between Authority and National REC

12. The Authority and a National REC may cooperate on the execution of tasks pursuant to the EU Regulation, to the extent that it is necessary and appropriate, for the purpose of performing their functions.

Starting of clinical investigations

13. A sponsor shall not start a clinical investigation, whether in relation to a device referred to in Article 70(7)(a) or (b) of the EU Regulation until the Authority has notified the sponsor of its authorisation in accordance with the time period referred to in Article 70(7)(b) of the EU Regulation.

Requirements in respect of clinical investigations not performed for purpose listed in Article 62(1) or Article 74 of EU Regulation

14. (1) This Regulation applies to clinical investigations not performed pursuant to any of the purposes listed in Article 62(1) or Article 74 of the EU Regulation.

(2) In addition to the requirements referred to in Article 82(1) of the EU Regulation, the following requirements shall also apply to clinical investigations referred to in paragraph (1):

(a) the requirements in Articles 69 and 76 of the EU Regulation;

(b) the sponsor shall notify the Authority in writing at least 30 days prior to its commencement;

(c) the sponsor shall record and report adverse events during the clinical investigation in line with the requirements of Article 80 of the EU Regulation, unless the device is CE marked, in which case the provisions of Articles 87 to 90, and the acts adopted pursuant to Article 91 of the EU Regulation, shall apply instead, and

(d) such additional requirements as the Authority may, on a case by case basis, require the sponsor to comply with following the receipt of notification from the sponsor under subparagraph (b).

Appeals of decisions in relation to clinical investigations

15. (1) A sponsor may, within 28 days of receipt of the relevant decision from the Authority, bring an appeal against—

(a) a decision by the Authority, pursuant to Article 70(3) of the EU Regulation, to refuse authorisation for a clinical investigation on the grounds that it does not fall within the scope of the EU Regulation or that the application dossier is not complete,

(b) a decision by the Authority, pursuant to Article 71(4) of the EU Regulation, to refuse authorisation for a clinical investigation on one of the grounds listed in that provision, or

(c) a decision by the Authority, pursuant to Article 75(3)(a) of the EU Regulation, to refuse authorisation for a substantial modification to a clinical investigation.

(2) The Authority shall publish guidelines setting out the procedures applicable to appeals under paragraph (1).

PART 4

OFFENCES AND PENALTIES

Offences by manufacturers

16. (1) Subject to Regulation 40, a manufacturer who—

(a) makes available on the market or puts into service a device which fails to comply with applicable common specifications pursuant to Article 9 of the EU Regulation,

(b) makes available on the market or puts into service a device which has not been designed or manufactured in accordance with the requirements of the EU Regulation,

(c) fails to establish, document, implement or maintain a system for risk management of devices as described in Section 3 of Annex I to the EU Regulation,

(d) makes available on the market or puts into service a device without conducting a clinical evaluation in accordance with the requirements set out in Article 61 of, and Annex XIV to, the EU Regulation, including a PMCF,

(e) makes available on the market or puts into service a device other than a custom-made device but fails to draw up or keep up to date technical documentation in accordance with Article 10(4) of the EU Regulation,

(f) makes available on the market or puts into service a custom-made device but fails to draw up, keep up to date or keep available for the Authority documentation in accordance with Section 2 of Annex XIII to the EU Regulation,

(g) fails to keep technical documentation, a declaration of conformity or a copy of any relevant certificate, including any amendments and supplements, issued in accordance with Article 56 of the EU Regulation, available for the Authority in accordance with Article 10(8) of the EU Regulation,

(h) fails to establish or maintain a quality management system in accordance with Article 10(9) of the EU Regulation,

(i) makes available on the market or puts into service a device which is not accompanied by the information set out in Section 23 of Annex I to the EU Regulation in the manner required by Article 10(11) of the EU Regulation,

(j) places on the market or puts into service a device which it considers or has reason to believe is not in conformity with the EU Regulation and fails to take corrective action in accordance with Article 10(12) of the EU Regulation, and inform the distributor, and where applicable the authorised representative and importers, accordingly,

(k) fails to comply with a request under Article 10(14) of the EU Regulation, to provide information and documentation necessary to demonstrate the conformity of a device, or a sample free of charge or grant access to a device,

(l) fails to comply with a request under Article 10(14) of the EU Regulation to cooperate with corrective action taken to eliminate or, if that is not possible, mitigate the risks posed by a device which it has placed on the market or put into service,

(m) fails to put in place a necessary measure in accordance with Article 10(16) of the EU Regulation to provide sufficient financial coverage in respect of potential liability under Council Directive 85/374/EEC of 25 July 19857 ,

(n) fails to have available within his or her organisation, or permanently and continuously at his or her disposal, as required by Article 15 of the EU Regulation, at least one person responsible for regulatory compliance,

(o) has more than one person responsible for regulatory compliance and fails to stipulate in writing their respective areas of responsibility,

(p) places a medical device on the market in respect of which a person responsible for regulatory compliance has not been appointed in accordance with Article 15 of the EU Regulation,

(q) is not established in a member state and places on the market a device in respect of which an authorised representative has not been designated in accordance with Article 11 of the EU Regulation,

(r) changes its authorised representative without entering into an agreement in accordance with Article 12 of the EU Regulation,

(s) makes available on the market or puts into service a device which contains a substance which is classified as a CMR substance listed in Annex I point 10.4 to the EU Regulation, other than in accordance with the corresponding restrictions laid down in that Annex,

(t) makes available on the market or puts into service a device, other than a custom made or investigational device, that does not have affixed to it a CE marking in accordance with Article 20 of the EU Regulation,

(u) fails to provide with an implantable device the required information, in accordance with Article 18 of the EU Regulation, so that it can be provided to the patient implanted with the device,

(v) makes available on the market or puts into service a device, other than a custom made or investigational device, but fails to draw up a declaration of conformity in relation thereto in accordance with Article 19 of the EU Regulation,

(w) places on the market a device, other than a custom-made device, without first assigning to it a UDI in accordance with Article 27(3) of the EU Regulation and transferring to the UDI database the information referred to in that provision,

(x) places a device on the market without placing UDI carriers on the label of the device and on all higher levels of packaging, in accordance with Article 27(4) of the EU Regulation,

(y) fails to keep up-to-date a list of all UDIs that he or she has assigned,

(z) places on the market a device, other than a custom-made device, which has not been registered in the electronic system in accordance with Article 29 of the EU Regulation,

(aa) places on the market a device, other than a custom-made device, without first assigning a basic UDI-DI to it in accordance with Article 29 of the EU Regulation,

(bb) places on the market a device, other than a custom-made device, without providing the basic UDI-DI to the UDI database together with the other core elements referred to in Part B of Annex VI related to that device,

(cc) places on the market a device, other than a custom-made device, without first entering or verifying in Eudamed the information referred to in Article 29(4) of the EU Regulation,

(dd) fails to update information entered in Eudamed pursuant to Article 29(4) of the EU Regulation,

(ee) in the case of an implantable device and class III device, other than a custom-made or investigational device, which it places on the market, fails to include on the label or instructions for use information as to where the summary of safety and clinical performance referred to in Article 32 of the EU Regulation is available,

(ff) places on the market a custom-made device without first following the procedure set out in Annex XIII to the EU Regulation and drawing up the statement set out in Section 1 of that Annex,

(gg) fails to keep up to date and keep available for the Authority documentation in accordance with Section 2 of Annex XIII.

(hh) fails to fulfil the post-market surveillance obligations in accordance with Chapter VII, Section 1 of the EU Regulation,

(ii) fails to comply with vigilance requirements in accordance with Chapter VII, Section 2 of the EU Regulation,

(jj) terminates its contract with a notified body and enters into a contract with a new notified body without executing an agreement in compliance with Article 58(1) of the EU Regulation, or

(kk) fails to update the clinical evaluation of a device it has placed on the market or put into service, or the documentation relating thereto, in accordance with Article 61(11) of the EU Regulation,

(ll) fails to comply with the registration obligations laid out in Article 31 of the EU Regulation,

is guilty of an offence.

(2) The offences listed in paragraph (1) also apply to an authorised representative where it has been validly delegated, or is otherwise legally responsible for, the applicable manufacturer’s obligation under the EU Regulation, in accordance with Article 11 thereof.

(3) Subject to paragraphs (4) and (5), the offences listed in paragraph (1) also apply to a distributor, importer or other natural or legal person where he, she or it—

(a) makes available on the market a device under his, her or its name, registered trade name or registered trade mark, except in cases where a distributor or importer enters into an agreement with a manufacturer whereby the manufacturer is identified as such on the label and is responsible for meeting the requirements placed on manufacturers in the EU Regulation,

(b) changes the intended purpose of a device already placed on the market or put into service, or

(c) modifies a device already placed on the market or put into service in such a way that compliance with the applicable requirements of the EU Regulation may be affected,

in which circumstances, such person shall be regarded as the manufacturer for the purpose of the said offences.

(4) Paragraph (3)(a) shall not apply to any person who, while not considered a manufacturer, assembles or adapts for an individual patient a device already on the market without changing its intended purpose.

(5) For the purposes of paragraph (3)(c), the actions listed in Article 16(2) of the EU Regulation shall not be considered to be a modification of a device that could affect its compliance with the applicable requirements.

(6) The offences listed in paragraph (1) also apply to a person who combines a device with a system or procedure pack in the circumstances referred to in Article 22(4) of the EU Regulation, and in such circumstances such person shall be regarded as the manufacturer and the system or procedure pack shall be regarded as a device in its own right.

(7) The offences listed in paragraph (1) also apply to a person who reprocesses a single-use device to make it suitable for further use within a member state, pursuant to Regulation 7, in which case the person shall be considered to be the manufacturer of the reprocessed device.

Offences by authorised representatives

17. Subject to Regulation 40, an authorised representative who—

(a) fails to provide to the Authority a copy of a mandate agreed between it and the manufacturer which is in accordance with Article 11 of the EU Regulation,

(b) fails to verify that the EU declaration of conformity and technical documentation have been drawn up in respect of a device in respect of which he or she has been designated,

(c) if applicable, fails to verify that an appropriate conformity assessment has been carried out by the manufacturer of a device in respect of which he or she has been designated,

(d) fails to keep available, at the disposal of the Authority for the period referred to in Article 10(8) of the EU Regulation, a copy of—

(i) the technical documentation,

(ii) the EU declaration of conformity, or

(iii) any relevant certificate issued in accordance with Article 56 of the EU Regulation,

in relation to a device in respect of which he or she has been designated,

(e) fails to comply with the registration obligations laid down in Article 31 of the EU Regulation in relation to a device in respect of which he or she has been designated,

(f) fails to verify that the manufacturer of a device in respect of which he or she has been designated has complied with the registration obligations laid down in Articles 27 and 29 of the EU Regulation,

(g) fails to provide to the Authority, on request, information or documentation necessary to demonstrate the conformity of a device in respect of which he or she has been designated,

(h) fails to forward to the manufacturer of a device in respect of which he or she has been designated any request from the Authority for samples or access to the device, or fails to verify that the Authority receives such samples or is given such access,

(i) fails to cooperate with the Authority on any preventive or corrective action taken to eliminate or mitigate the risks posed by a device in respect of which he or she has been designated,

(j) fails to immediately inform the manufacturer of a device in respect of which he or she has been designated about a complaint or report from a healthcare professional, patient or user about a suspected incident related to the device,

(k) fails to immediately inform the Authority or any relevant notified body of the termination of its mandate, where required under Article 11(6) of the EU Regulation, or

(l) fails to have permanently and continuously at his or her disposal at least one person responsible for regulatory compliance, in accordance with Article 15(6) of the EU Regulation,

is guilty of an offence.

Offences by distributors

18. Subject to Regulation 40, a distributor who—

(a) makes available on the market a device, other than a custom-made or investigational device, which has not been CE marked in accordance with Article 20 of the EU Regulation,

(b) makes available on the market a device which does not have an EU declaration of conformity in accordance with Article 19 of the EU Regulation,

(c) makes available on the market a device which is not accompanied by the information to be supplied by the manufacturer in accordance with Article 10(11) of the EU Regulation,

(d) makes available on the market an imported device in respect of which the importer has not complied with the requirements in Article 13(3) of the EU Regulation,

(e) makes available on the market a device, other than a custom-made device, which has not been assigned a Unique Device Identifier (UDI) by the manufacturer,

(f) makes available on the market a device which it considers, or has reason to believe, is not in conformity with the EU Regulation,

(g) considers or has reasons to believe that a device which the distributor has made available on the market is not in conformity with the EU Regulation and fails to inform the manufacturer and the importer, and where applicable the manufacturer’s authorised representative, of such non-conformity in accordance with Article 14(2) of the EU Regulation,

(h) considers or has reason to believe that a device presents a serious risk or is a falsified device and fails to inform the relevant competent authority of such risk in accordance with Regulation 14(2) of the EU Regulation,

(i) stores or transports a device without complying with the conditions set by the manufacturer,

(j) considers or has reason to believe that a device which he or she has made available on the market is not in conformity with the EU Regulation and fails to take corrective measures in accordance with Article 14(4) of the EU Regulation,

(k) receives a complaint or report about a suspected incident related to a device it has made available, but fails to comply with Regulation 14(5) of the EU Regulation,

(l) fails to provide the Authority with information, documentation, cooperation or a sample, or access to, a device following a request by the Authority under Article 14(6) of the EU Regulation, or

(m) carries out any of the activities referred to in Article 16(2) of the EU Regulation and fails to—

(i) provide the information required by Article 16(3) of the EU Regulation with the device concerned,

(ii) have in place a quality management system in accordance with the requirements of Article 16(3) of the EU Regulation, or

(iii) provide the manufacturer and the competent authority with information or documentation in accordance with Article 16(4) of the EU Regulation,

is guilty of an offence.

Offences by importers

19. Subject to Regulation 40, an importer who—

(a) places on the market a device which has not been CE marked in accordance with Article 20 of the EU Regulation,

(b) places on the market a device which does not have an EU declaration of conformity in accordance with Article 19 of, and Annex IV to, the EU Regulation,

(c) places on the market a device which the importer considers, or has reason to believe, is not in conformity with the requirements of the EU Regulations,

(d) places on the market a device in respect of which the manufacturer has not been identified,

(e) places on the market a device in respect of which an authorised representative has not been designated in accordance with Article 11 of the EU Regulation,

(f) is established in the State and fails to inform the Authority that it considers, or has reason to believe, that a device it intended to place on the market presents a serious risk or is a falsified device,

(g) places on the market a device which is not labelled in accordance with the EU Regulation or is not accompanied by the required instructions for use,

(h) places on the market a device, other than a custom-made device, which has not been assigned a UDI by the manufacturer in accordance with Article 27 of the EU Regulation,

(i) places on the market a device without complying with the information and labelling requirements in Article 13(3) of the EU Regulation,

(j) places on the market a device, other than a custom-made device, which has not been registered in the electronic system in accordance with Article 29 of the EU Regulation,

(k) within 2 weeks of placing on the market a device, other than a custom-made device, which has already been registered on the electronic system referred to in Article 30 of the EU Regulation, on the market, fails to—

(i) verify that the manufacturer or authorised representative of the device has provided the information referred to in Section 1 of Part A of Annex VI to the EU Regulation to, or

(ii) add its details to the relevant entry or entries in,

the said electronic system.

(l) stores or transports a device under its responsibility in a manner contrary to the requirements of Article 13(5) of the EU Regulation,

(m) fails to keep a register, or provide information, in accordance with Article 13(6) of the EU Regulation,

(n) fails to inform the manufacturer or authorised representative, in accordance with Article 13(7) of the EU Regulation, where it considers or has reasons to believe that a device which the importer has placed on the market is not in conformity with the EU Regulation,

(o) fails to cooperate in corrective measures required under Article 13(7) of the EU Regulation,

(p) fails to inform the relevant competent authorities or notified body, in accordance with Article 13(7) of the EU Regulation, where a device it has placed on the market presents a serious risk,

(q) fails to forward to the manufacturer or its authorised representative information in relation to complaints or reports of suspected incidents related to a device the importer has placed on the market, in accordance with Regulation 13(8) of the EU Regulation,

(r) fails to keep a copy of the EU declaration of conformity or any relevant certificate, in accordance with Article 13(9) of the EU Regulation,

(s) fails to provide the Authority with cooperation, or samples or access to a device, upon request by the Authority under Article 13(10) of the EU Regulation, or

(t) carries out any of the activities referred to in Article 16(2) of the EU Regulation and fails to—

(i) provide the information required by Article 16(3) of the EU Regulation with the device concerned,

(ii) have in place a quality management system in accordance with the requirements of Article 16(3) of the EU Regulation, or

(iii) provide a manufacturer or the Authority with information or documentation in accordance with Article 16(4) of the EU Regulation,

is guilty of an offence.

Offences – economic operators

20. Subject to Regulation 40, an economic operator who—

(a) fails to identify any of the persons or institutions referred to in Article 25(2) of the EU Regulation during the period referred to in Article 10(8) of the EU Regulation,

(b) fails to store and keep the UDI of a device referred to in Article 27(8) of the EU Regulation which he or she has supplied or with which he or she has been supplied,

(c) fails to update the data in relation to a device for which it is responsible in the electronic system referred to in Article 30 of the EU Regulation within one week of a change occurring in relation to information referred to in Article 31(1) of the EU Regulation,

(d) fails, within one year of submission or every second year thereafter, to confirm the accuracy of the information in the electronic system in accordance with Article 31(1) of the EU Regulation in relation to a device for which it is responsible,

(e) fails to make documentation or information available to the Authority in accordance with a request under Article 93(3)(a) of the EU Regulation,

(f) fails to provide a sample of, or access free of charge to, a device in accordance with a request under Article 93(3)(a) of the EU Regulation,

(g) fails to allow the Authority access to his or her premises for the purposes of an inspection under Article 93(3)(b) of the EU Regulation,

(h) fails to cooperate with the Authority in relation to the evaluation, under Article 94 of the EU Regulation, of a device for which it is responsible,

(i) fails to take corrective action required by the Authority under Article 95 of the EU Regulation,

(j) fails to bring to an end a non-compliance with the EU Regulation, in accordance with a request by the Authority under Article 97 of the EU Regulation,

is guilty of an offence.

Offences by notified bodies

21. Subject to Regulation 40, a notified body which—

(a) fails to comply with the requirements of Article 36(1) of the EU Regulation,

(b) fails, where requested, to make available and submit relevant documentation to the Authority in accordance with Article 36(2) of the EU Regulation,

(c) delegates specific tasks connected with conformity assessment to a subcontractor or subsidiary which does not meet the applicable requirements set out in Annex VII to the EU Regulation,

(d) fails to inform the Authority, pursuant to Article 37(1) of the EU Regulation, that a subcontractor or subsidiary is carrying out specific tasks connected with conformity assessment on its behalf,

(e) fails to make publicly available a list of its subsidiaries in accordance with Article 37(3) of the EU Regulation,

(f) fails to inform an applicant for conformity assessment, pursuant to Article 37(4) of the EU Regulation, that conformity assessment activities will be carried out by a subcontractor or subsidiary,

(g) fails to keep at the disposal of the Authority, pursuant to Article 37(5) of the EU Regulation, all relevant documents concerning the verification of the qualifications of a subcontractor or subsidiary carrying out tasks connected with conformity assessment on its behalf and the tasks carried out by the subcontractor or subsidiary,

(h) fails to inform the Authority, pursuant to Article 38(3) of the EU Regulation, of a relevant change in the documentation referred to in Article 38(2) of the EU Regulation,

(i) fails to inform the Authority within 15 days, pursuant to Article 44(1) of the EU Regulation, of a relevant change which may affect its compliance with the requirements set out in Annex VII to the EU Regulation or its ability to conduct the conformity assessment activities relating to the devices for which it has been designated,

(j) fails to comply with a request by the Authority to supply information and documents pursuant to Article 44(2) of the EU Regulation,

(k) fails to comply with a request by the Commission or the authority of a member state other than the State, pursuant to Article 44(3) of the EU Regulation, within 15 days of such request,

(l) fails to inform the Authority, in accordance with Article 46(3) of the EU Regulation, that it intends to cease conformity assessment activities,

(m) fails to inform a manufacturer concerned that the notified body’s designation has been suspended, restricted or fully or partially withdrawn pursuant to Article 46(4) of the EU Regulation,

(n) fails to suspend or withdraw an unduly issued certificate in accordance with a request by the Authority under Article 46(4) of the EU Regulation,

(o) fails to make publicly available, in accordance with Article 50 of the EU Regulation, a list of its standard fees for the conformity assessment activities that it carries out,

(p) fails to notify the competent authorities, through the electronic system referred to in Article 57 of the EU Regulation, of a certificate it has granted to a device in respect of which it has performed a conformity assessment, in accordance with Article 55(4) of the EU Regulation,

(q) fails to take appropriate action to address the failure of a manufacturer to meet the requirements of the EU Regulation, in accordance with Article 56(4) of the EU Regulation,

(r) fails to enter in the electronic system referred to in Article 57 of the EU Regulation the information referred to in Article 56(5) of the EU Regulation regarding a certificate it has issued,

(s) enters into a contract with a manufacturer which is changing notified bodies without executing an agreement in compliance with Article 58(1) of the EU Regulation,

(t) fails to withdraw, in accordance with Article 58(2) of the EU Regulation, a certificate it issued which has become invalid in the context of the termination of the contract with the manufacturer,

is guilty of an offence.

Offences by health institutions

22. Subject to Regulation 40, a health institution which—

(a) manufactures and uses an in-house device which is not in compliance with the relevant general safety and performance requirements set out in Annex I to the EU Regulation,

(b) fails to comply with Regulation 6,

(c) fails to comply with a condition in Article 5(5) of the EU Regulation in respect of an in-house device which it manufactures and uses, or

(d) fails to store and keep the UDI of a class III implantable device which it has supplied or with which it has been supplied,

is guilty of an offence.

Offences by sponsors

23. (1) Subject to paragraphs (3) to (7) and Regulation 40, a sponsor who, in respect of a clinical investigation to be, or being, conducted in the State, for which the sponsor is responsible—

(a) fails to ensure that the clinical investigation is designed, authorised, conducted, recorded and reported in accordance with Article 62(1) of the EU Regulation, where applicable,

(b) fails to ensure that the clinical investigation is designed and conducted in accordance with Article 62(3) of the EU Regulation,

(c) fails to ensure that all of the conditions listed in Article 62(4) of the EU Regulation are met,

(d) fails to submit to the Authority a copy of an opinion of a National REC in respect of a clinical investigation in accordance with Regulation 11,

(e) starts the clinical investigation otherwise than in accordance with Article 70(7) of the EU Regulation and Regulation 13,

(f) fails to ensure that the clinical investigation is conducted in accordance with the approved clinical investigation plan,

(g) fails to ensure adequate monitoring of the conduct of the clinical investigation in accordance with Article 72(2) of the EU Regulation,

(h) fails to ensure that information in relation to the clinical investigation is recorded, processed, handled and stored in accordance with Article 72(3) of the EU Regulation,

(i) fails to inform the Authority of the temporary halting or early termination of the clinical investigation in accordance with Article 77(1) of the EU Regulation,

(j) fails to notify the Authority of the end of the clinical investigation in accordance with Article 77(3) or (4) of the EU Regulation,

(k) fails to submit a clinical investigation report in accordance with Article 77(5) of the EU Regulation,

(l) fails to record information referred to in Article 80(1) of the EU Regulation in relation to an adverse event, or

(m) fails to report to the Authority the information referred to in Article 80(2) of the EU Regulation in relation to a serious adverse event, in accordance with that provision or Article 80(3) or (4) of the EU Regulation, as applicable,

is guilty of an offence.

(2) A sponsor of a clinical investigation in the State who is not established in the European Economic Area is guilty of an offence where he or she fails to ensure that a natural or legal person is established in the European Economic Area as its legal representative (“legal representative”) in accordance with Article 62(2) of the EU Regulation,

(3) Where a legal representative has been appointed in accordance with Article 62(2), the offences listed in paragraph (1) apply to the legal representative in place of the sponsor.

(4) A sponsor or legal representative, as the case may be, is not guilty of an offence under paragraph (1) by reason of the failure to ensure compliance with Article 62(4)(f), 63, 64(1)(a) or (b) or 65(1)(a) or (b) of the EU Regulation where an emergency situation derogation under Article 68(1) of the EU Regulation applies and the relevant requirements of Article 68(2) and (3) of the EU Regulation are met.

(5) In the case of a clinical investigation coming within the scope of Article 74(1) of the EU Regulation (“PMCF investigation”), which is considered notifiable to the Authority, the offences in paragraph (1) shall not apply, other than those at subparagraphs (i), (j) and (k) thereof, and the sponsor or legal representative of the clinical investigation is, in addition, guilty of an offence where it—

(a) fails to ensure that the conditions listed in Article 62(4)(b) to (k) and (m) of the EU Regulation are met, or

(b) fails to ensure that the provisions on vigilance laid down in Articles 87 to 90 of the EU Regulation are complied with.

(6) Notwithstanding paragraph (5), the offences in paragraph (1)(l) and (m) shall apply to the sponsor or legal representative of a PMCF investigation where a causal relationship between the serious adverse event and the preceding investigational procedure has been established.

(7) In the case of a clinical investigation referred to in Regulation 14(1), the offences in paragraph (1) shall not apply, but the sponsor or legal representative of the clinical investigation is guilty of an offence where it fails to ensure compliance with—

(a) the requirements of Article 82(1) of the EU Regulation, or

(b) the requirements listed in Regulation 14(2).

Offences - general

24. Subject to Regulation 40, a person who—

(a) makes available on the market or puts into service a device which fails to comply with a general safety and performance requirement under Annex I to the EU Regulation which applies to it taking into account its intended purpose,

(b) makes available on the market or puts into service a combination product the device part of which does not comply with the relevant general safety and performance requirements set out in Annex I to the EU Regulation,

(c) offers by means of information society services, to a natural or legal person established in a member state, a device which is not in compliance with the EU Regulation,

(d) uses in the context of a commercial activity, whether in return for payment or free of charge, for the provision of a diagnostic or therapeutic service offered by means of information society services or by other means of communication, directly or through intermediaries, to a natural or legal person established in a member state, a device which is not in compliance with the EU Regulation,

(e) offers a device by means of information society services in accordance with Article 6(1) of the EU Regulation, or provides a service in accordance with Article 6(2) of the EU Regulation, and fails to make available to the Authority on request a copy of the EU declaration of conformity of the device,

(f) fails to comply with a request by the Authority pursuant to Article 6(4) of the EU Regulation to cease providing information society services,

(g) in the labelling, instructions for use, making available, putting into service or advertising of a device, uses text, names, trademarks, pictures or figurative or other signs that may mislead the user or the patient contrary to Article 7 of the EU Regulation,

(h) makes available on the market a custom-made device which is not accompanied by the statement referred to in Section 1 of Annex XIII to the EU Regulation,

(i) combines a device bearing a CE marking with a device or product listed in Article 22(1) of the EU Regulation in the manner referred to in that provision without drawing up a statement in accordance with Article 22(2) of the EU Regulation,

(j) sterilises systems or procedure packs referred to in Article 22(1) of the EU Regulation without complying with Article 22(3) of the EU Regulation,

(k) having made a statement referred to in Article 22(2) of the EU Regulation, fails to keep it available for the Authority in accordance with Articles 22(5) and 10(8) of the EU Regulation,

(l) makes available on the market an item, specifically intended to replace an identical or similar integral part or component of a device in the circumstances referred to in Article 23(1) of the EU Regulation, which adversely affects the safety and performance of the device,

(m) having made available on the market an item referred to in Article 23(1) of the EU Regulation, fails to keep supporting evidence of compliance with that provision available for the Authority,

(n) places on the market a system or procedure pack pursuant to Article 22(1) and (3) of the EU Regulation, that is not a custom-made device, without first assigning to the system or procedure pack a Basic UDI-DI

(o) places on the market a system or procedure pack pursuant to Article 22(1) and (3) of the EU Regulation, that is not a custom-made device, without providing the Basic UDI-DI to the UDI database, in accordance with Article 29(2) of the EU Regulation,

(p) places on the market, or puts into service, a device that has not been the subject of a conformity assessment in accordance with Article 52 of the EU Regulation or which has not been subject of a derogation granted under Article 59 of the EU Regulation,

(q) fails to comply with a request, notice or order made under these Regulations,

(r) in purported compliance with a request, notice or order under these Regulations gives information to the Authority or an authorised officer that he or she knows to be false or misleading in any material respect,

(s) obstructs or interferes with the Authority, an authorised officer, a member of An Garda Síochána or a person with expertise relating to any relevant thing, in the course of performing a function conferred on him, her or it by these Regulations,

(t) falsely represents himself or herself to be an authorised officer under these Regulations,

(u) impedes the performance by a person referred to in paragraph (s) of such function, or fails or refuses to comply with a request or requirement of, or to answer a question asked by such person,

(v) discloses any confidential information to which he or she has access by virtue of these Regulations, otherwise than in accordance with these Regulations,

(w) discloses or uses for business or commercial purposes or any other purpose any information relating to a CE marking approval application in the possession of a notified body without the consent of that body,

(x) fails to take reasonable measures to guarantee confidentiality with regard to forwarding any documentation required under these Regulations,

(y) makes a false document or possesses or uses a document knowing it to be false or purporting to be issued, granted, given or required under this Regulation or the EU Regulation (“a false document”),

(z) alters with intent to defraud or deceive, or uses knowing it to be so altered, a document issued, granted, given or required under this Regulation or the EU Regulation (“an altered document”),

(aa) without lawful authority, has in his or her possession a false document or an altered document,

(bb) tampers with any substance or device, or parts, material or accessory designated to be used as part of or with a device,

(cc) tampers or interferes with any sample taken under Regulation 29(3)(i) or (j),

(dd) being a supplier of a device, or a subcontractor of a manufacturer, fails to allow the Authority access to his or her premises for the purposes of an inspection under Article 93(3)(b) of the EU Regulation,

(ee) being a professional user of a device, fails to allow the Authority access to his or her facilities for the purpose of a necessary inspection under Article 93(3)(b) of the EU Regulation, or

(ff) reprocesses a single-use device to make it suitable for further use within a member state otherwise than in accordance with Regulation 7.

is guilty of an offence.

Provisions related to offences

25. (1) For the purpose of these Regulations, every contravention of a provision of these Regulations shall be deemed a separate contravention and every contravention of a paragraph or a subparagraph of such provision shall also be deemed to be a separate contravention and shall carry the same penalty as for a single contravention of any such provision.

(2) Where a person is convicted of an offence under these Regulations, the court shall, unless it is satisfied that there are special and substantial reasons for not doing so, order the person to pay to the Authority the costs and expenses, measured by the court, incurred by the Authority, in relation to the investigation, detection and prosecution of the offence, including costs and expenses incurred in the taking of samples, the carrying out of tests, examinations and analyses and in respect of the remuneration and other expenses of employees, consultants and advisors engaged by the Authority.

(3) On conviction for an offence under these Regulations, the court may, in addition to any other penalty or cost—

(a) order any relevant thing or any vehicle, vessel or container to which the offence relates to be forfeited to the Authority for destruction or disposal as the Authority thinks fit, and

(b) upon application made to it by or on behalf of the Authority, order the person convicted of the offence to pay to the Authority all or part of the costs of the destruction or disposal of such relevant thing or any vehicle, vessel or container, subject to such conditions, if any, as specified in the order.

(4) An order for costs and expenses under paragraph (2) or (3) is in addition to, and not instead of, any fine or penalty the court may impose.

(5) In any proceedings for an offence under these Regulations, where no conviction is recorded, the court may, upon application made to it by or on behalf of the Authority, order any relevant thing to which the offence relates to be forfeited to the Authority for destruction or disposal.

Proceedings

26. (1) Proceedings in relation to a summary offence under these Regulations may be brought and prosecuted by the Authority.

(2) In proceedings for an offence under these Regulations, a certificate or report signed by an approved examiner stating the results of any test, examination or analysis of a sample shall, with regard to that sample, be evidence of the matters stated in the certificate or report unless the contrary is proved.

(3) In proceeding for an offence under these Regulations, a relevant thing, or package containing a relevant thing, that purports to bear the name of the manufacturer or importer of that thing, or of the person who made that thing available on the market, shall, unless the contrary is proved, be evidence that the relevant thing was manufactured or imported, or made available on the market, as the case may be, by the person so named.

PART 4

COMPLIANCE AND ENFORCEMENT

Enforcement generally

27. (1) These Regulations, and the provisions of the EU Regulation to which they refer, shall be enforced by the Authority.

(2) In carrying out its compliance and enforcement role under the EU Regulation and these Regulations, the Authority shall adhere to the principle of good administrative practice, as provided for in Article 99 of the EU Regulation.

Authorised officers

28. (1) For the purposes of ensuring compliance with the EU Regulation and these Regulations, the chief executive of the Authority—

(a) may appoint such and so many persons as he or she thinks fit to be authorised officers for the purpose of these Regulations, and

(b) shall furnish each authorised officer appointed by him or her with a warrant of the authorised officer’s appointment.

(2) An authorised officer, other than an authorised officer who is an officer of Customs and Excise, shall, when performing a function imposed under these Regulations on an authorised officer, produce his or her warrant for inspection if requested to do so by a person affected by the performance of that function.

(3) For the purposes of ensuring compliance with the EU Regulation or the Market Surveillance Regulation, an authorised officer may—

(a) subject to paragraph (5), enter (if necessary by the use of reasonable force), at all reasonable times, any premises at which he or she has reasonable grounds for believing that—

(i) any trade, business or activity connected with the manufacture, processing, sterilisation, disposal, export, import, distribution, sale, supply, storage, packaging, labelling, preparation, professional use, conformity assessment, or advertising of any relevant thing or the processing of financial transactions in relation to the relevant thing is or has been carried on, or

(ii) books, records or other documents (including documents stored in non-legible form) relating to such trade, business or activity or the processing of financial transactions in relation to the relevant thing are kept,

(b) at such premises inspect and take copies of, any books, records, other documents (including documents stored in non-legible form) or extracts therefrom, which he or she finds in the course of his or her inspection,

(c) remove any such books, records or other documents from such premises and detain them for such period as he or she reasonably considers to be necessary for the purposes of his or her functions under these Regulations,

(d) carry out, or have carried out, such tests, examinations, analyses, inspections and checks of—

(i) the premises,

(ii) any relevant thing at the premises, or

(iii) any equipment, machinery or plant at the premises,

as he or she reasonably considers to be necessary for the purposes of his or her functions under these Regulations,

(e) require any person at the premises, the owner or person in charge of the premises or any person employed there to give to him or her such assistance and information and to produce to him or her such books, records or other documents (and in the case of documents or records stored in non-legible form, produce to him or her a legible reproduction thereof) that are in that person’s power or procurement, as he or she may reasonably require for the purposes of his or her functions under these Regulations,

(f) purchase or take without payment a sample of any relevant thing found at the premises for the purposes of any test, examination or analysis,

(g) secure and detain for later inspection any premises or part of any premises in which a relevant thing is found or ordinarily kept, or books, records or other documents are found or ordinarily kept, for such period as may reasonably be necessary for the purposes of his or her functions under these Regulations,

(h) without payment, take possession of and remove from the premises for any test, examination or analysis any relevant thing found there, and detain it for such period as he or she considers reasonably necessary for the purposes of his or her functions under these Regulations,

(i) without payment, take samples of any relevant thing detained pursuant to subparagraph (j), for the purposes of any test, examination, or analysis,

(j) where the taking of samples of any relevant thing pursuant to subparagraph (f) or (i) is, for whatever reason, not practicable, purchase or take without payment the relevant thing concerned for the purposes of any test, examination or analysis, or carry out testing, examination or analysis of the relevant thing at the premises,

(k) stop any person, vehicle, vessel or container at the premises,

(l) board and search any such vehicle, vessel or container,

(m) require the name and address of any person on the premises,

(n) make a record whether in writing, by photography or otherwise,

(o) inspect and copy or extract information from any data within the meaning of the Data Protection Acts 1988 to 2018,

(p) require a person, having authority to do so, to break open any container, receptacle or package, or to open any vending machine, or to permit him or her to do so, as he or she may reasonably require for the purposes of his or her functions under these Regulations,

(q) require a person, who makes available facilities such as post office boxes, telecommunications, financial payment services, electronic mail addresses or other like facilities, to give him or her such assistance and information as he or she may reasonably require for the purposes of his or her functions under these Regulations in any case where the officer has reasonable grounds for believing that any relevant thing is being supplied by information society services or mail order, or in contravention of any provision of these Regulations or the EU Regulation relating to any trade, business or activity referred to in subparagraph (a)(i), or books, records or documents referred to in subparagraph (a)(ii), or

(r) where no other effective means are available to eliminate a serious risk—

(i) require the removal of content referring to devices and related products from an online interface or require the explicit display of a warning to end users when they access an online interface, or

(ii) where a request under clause (i) has not been complied with, require information society service providers to restrict access to the online interface, including by requesting a relevant third party to implement such measures.

(4) When performing a function under these Regulations, an authorised officer may, subject to any warrant under paragraph (6), be accompanied by such number of—

(a) other authorised officers,

(b) members of An Garda Síochána, or

(c) persons with expertise relating to any relevant thing,

as he or she considers appropriate in the circumstances of the case.

(5) An authorised officer shall not enter a dwelling, other than—

(a) with the consent of the occupier, or

(b) in accordance with a warrant issued under paragraph (6).

(6) Upon the application of an authorised officer, a judge of the District Court, if satisfied that there are reasonable grounds for believing that—

(a) a relevant thing is to be found in any dwelling, or is being or has been subjected to any process or stored in any dwelling,

(b) a dwelling is occupied in whole or in part by an undertaking engaged in any trade, business or activity referred to in paragraph (3)(a)(i), or

(c) books, records or other documents (including documents stored in non-legible form) referred to in paragraph (3)(a)(ii) are being stored or kept in any dwelling,

may issue a warrant authorising a named authorised officer accompanied by such other authorised officers, members of An Garda Síochána, or persons with expertise relating to any relevant thing, as may be necessary, at any time or times, within one month of the date of issue of the warrant, to enter the dwelling and perform any of the functions of an authorised officer under paragraph (3)(b) to (r).

(7) Where an authorised officer, upon reasonable grounds, believes that a person has committed an offence under these Regulations, he or she may require that person to provide him or her with his or her name, date of birth, and the address at which he or she ordinarily resides, and to produce corroborative evidence of same.

(8) Where an authorised officer has reasonable cause to suspect that—

(a) an offence is being or has been committed under these Regulations, or

(b) evidence of an offence or contravention may be, is or has been on or in any premises,

the authorised officer may, in addition to the powers exercisable by him or her under paragraph (3)—

(i) search a person, where the authorised officer considers it necessary,

(ii) seize and detain a vessel, vehicle, container, equipment, machinery or relevant thing,

(iii) dispose of a relevant thing, or require the owner or person in charge of or in possession of a relevant thing to deal with or dispose of it (or any other thing used in connection with, or that may have been in contact with, the relevant thing) in a manner that the authorised officer thinks fit.

(9) An authorised officer may dispose of, or cause to be disposed, a relevant thing, or a sample of a relevant thing, taken under this Regulation, in such manner and at such place as the authorised officer considers appropriate in the circumstances of the case.

(10) The costs (including ancillary costs) of any seizure, detention or disposal carried out by the Authority under paragraph (8) or (9) shall be recoverable as a simple contract debt in any court of competent jurisdiction from the relevant manufacturer, distributor, importer or other person responsible for the item seized, detained or disposed of.

(11) A statement or admission made by a person pursuant to a requirement under paragraph (3) shall not be admissible as evidence in proceedings brought against that person for an offence (other than an offence under these Regulations for failing to give information or giving false information).

(12) Nothing in this Regulation shall be taken to compel the production by any person of a document which he or she would be exempt from producing in proceedings in a court on the ground of legal professional privilege.

Taking of samples

29. (1) Subject to paragraph (3), where an authorised officer purchases or takes without payment a sample of a relevant thing pursuant to Regulation 28(3)(i) he or she may, where practicable—

(a) take multiple samples,

(b) place each sample into separate containers, and

(c) forthwith seal and mark each such container in such a manner as to identify it as part of the sample taken by the authorised officer.

(2) Where the authorised officer has, sealed and marked a sample of a relevant thing in accordance with paragraph (1), he or she shall—

(a) offer one of the sealed containers to the owner or the person for the time being in charge or possession of the relevant thing from which the sample concerned was taken,

(b) retain one of the sealed containers, and

(c) forward, or cause to be forwarded, one of the sealed containers for test, examination or analysis of the sample concerned by an approved examiner or where appropriate for examination by the Authority.

(3) Where a relevant thing is contained in a container and, for whatever reason, it is not practicable to take multiple samples, an authorised officer, who wishes to take samples of such relevant things for the purposes of any tests, examination or analysis may take possession of 3 such containers belonging to the same batch or lot, and each such container shall be deemed to be part of a sample for the purposes of paragraph (1), and the provision of paragraphs (1) and (2) shall apply thereto accordingly.

(4) Where an authorised officer purchases or takes without payment a relevant thing pursuant to Regulation 28(3)(j) he or she may, where practicable—

(a) place the relevant thing in a container,

(b) forthwith seal and mark the container in such a manner as to identify it as a relevant thing taken pursuant to that subparagraph, and

(c) forward, or cause to be forwarded, the sealed container for test, examination or analysis of the relevant thing by an approved examiner.

Production order

30. (1) For the purpose of investigating compliance with the EU Regulation and these Regulations, an authorised officer may apply to a judge of the District Court for an order under this Regulation (“production order”) in relation to making available any particular material or material of a particular description.

(2) On an application under paragraph (1), the judge, if satisfied—

(a) that there are reasonable grounds for suspecting that the person on whom the order is to be served has the material concerned in his or her possession or has access to such material, and

(b) that the material concerned is required for the purpose of such investigation,

may order that the person shall—

(i) produce the material to the authorised officer so that he or she may take it away, or

(ii) give the authorised officer access to it within a period to be specified in the order.

(3) The period to be so specified shall be one week, unless it appears to the judge that another period would be appropriate in the particular circumstances of the case.

(4) An order under this Regulation in relation to material in any place may, on the application of the authorised officer concerned, require any person who appears to the judge to be entitled to grant entry to the place to allow the authorised officer to enter it to obtain access to the material.

(5) Where a person required under paragraph (4) to allow an authorised officer to enter a place does not allow the authorised officer to do so, the person shall be treated as if he or she is in breach of a warrant issued under Regulation 28(6) authorising him or her to search the place and any person found there.

(6) Where material to which a production order relates consists of information stored electronically, the order shall have effect as an order to produce the material, or to give access to it, in a form in which it is visible and legible and in which it can be taken away.

(7) A production order —

(a) in so far as it may empower an authorised officer to take away a document or to be given access to it, shall authorise him or her to make a copy of it and to take the copy away,

(b) shall not confer any right to production of, or access to, any material subject to legal privilege, and

(c) shall have effect notwithstanding any other obligation as to secrecy or other restriction on disclosure of information imposed by statute or otherwise.

(8) Any material taken away by an authorised officer under this Regulation may be retained by him or her for use as evidence in any proceedings.

(9) A judge of the District Court may vary or discharge an order under this Regulation on the application of any person to whom an order under this Regulation relates or an authorised officer.

Quarantine notice

31. (1) Where an authorised officer, other than an authorised officer who is an officer of Customs and Excise, is of the opinion that—

(a) there is a potential non-compliance with a requirement of the EU Regulation in relation to a device or relevant thing, or

(b) a device or relevant thing has the potential to pose a serious risk to human health,

the authorised officer may, with the approval of the chief executive of the Authority, or another officer of the Authority designated by the chief executive of the Authority for that purpose, serve, or arrange to have served, on the manufacturer, authorised representative, distributor, health institution, economic operator, notified body or other person(s) concerned a notice (“quarantine notice”) in accordance with paragraph (2).

(2) A quarantine notice shall—

(a) be signed by the authorised officer issuing it, or the officer consulted in accordance with paragraph (1),

(b) state the reason why quarantine is being applied or provide a justification for the quarantine action,

(c) specify—

(i) the provision or provisions of the EU Regulation with which there is non-compliance and the matters giving rise to the non-compliance, or

(ii) the serious risk to human health posed by the device or relevant thing, and

(d) direct the person on whom the quarantine notice is served to ensure that the device or relevant thing is not made available on the market or put into service until all the necessary conditions for the device or relevant thing to be compliant have been met or the device or relevant thing no longer poses a serious risk to human health, as appropriate.

(3) The approval referred to in paragraph (1) may be given orally or in writing and if given orally shall be recorded in writing as soon as practicable.

(4) Save in the case of a quarantine notice which takes effect immediately when it is received by the person on whom it is served, a quarantine notice shall give the person on whom it is served a reasonable period within which he or she may put forward his or her viewpoint on the notice or appeal the notice.

(5) Where appropriate, the Authority shall, without delay, provide a copy of the quarantine notice to the person(s) responsible for regulatory compliance of the manufacturer or the authorised representative designated in respect of the relevant device or relevant thing, and where necessary any importer(s) or distributor(s).

(6) Subject to paragraph (7)(a), a quarantine notice shall give the person on whom it is served a reasonable period within which he or she may put forward his or her viewpoint on the notice or appeal the notice.

(7) A quarantine notice shall take effect—

(a) where required, and where the quarantine notice so declares, immediately when the notice is received by the person on whom it is served, or

(b) in any other case—

(i) where no appeal is taken against the quarantine notice, on expiration of the period referred to in paragraph (6), or

(ii) where an appeal is taken, on the day next following the day on which the quarantine notice is confirmed on appeal or the appeal is withdrawn or on the expiration of the period referred to in paragraph (6), whichever is the later.

(8) The chief executive of the Authority, or another officer of the Authority designated by the chief executive of the Authority for that purpose, may, for stated reasons, revoke or vary a quarantine notice issued by an authorised officer appointed by the Authority.

(9) In the event of non-compliance by the person on whom a quarantine notice has been served, an authorised officer, other than an authorised officer who is an officer of Customs and Excise, shall, with the approval of the chief executive of the Authority, or another officer thereof designated by the chief executive of the Authority for that purpose, take whatever measures are considered necessary to ensure compliance with the quarantine notice, including the seizure, detention and destruction of the device in question or the making of any arrangements for such seizure, detention and destruction.

(10) This Regulation shall not operate to prevent or restrict—

(a) the entitlement of the Authority to take other action to secure compliance with the EU legislation and these Regulations by a person, or

(b) the bringing or prosecuting of any proceedings for an offence under these Regulations.

Compliance notice

32. (1) Where an authorised officer, other than an authorised officer who is an officer of Customs and Excise, is of the opinion that there is non-compliance with a requirement of the EU Regulation, the authorised officer may, following consultation with another officer of the Authority designated by the chief executive of the Authority for that purpose, serve, or arrange to have served, on the person concerned a notice (“compliance notice”) in accordance with paragraph (2).

(2) A compliance notice shall—

(a) be signed by the authorised officer issuing it, or the officer consulted in accordance with paragraph (1),

(b) identify the requirement(s) of the EU Regulation with which there has not been compliance,

(c) identify the corrective actions to be taken,

(d) where appropriate, direct the person on whom the compliance notice is served to inform, without delay, the manufacturer, authorised representative, distributor(s) or importer(s) of the device concerned of the corrective actions to be taken, and

(e) give a time period, commensurate with the nature of the risk, within which the person on whom the compliance notice is served must take the corrective actions identified pursuant to subparagraph (c).

(3) Where appropriate, the authorised officer shall, without delay, provide a copy of the compliance notice to the person(s) responsible for regulatory compliance of the manufacturer or the authorised representative designated in respect of the device concerned and where necessary any importer(s) or distributor(s).

(4) Subject to paragraph (5)(a), a compliance notice shall give the person on whom it is served a reasonable period within which he or she may put forward his or her viewpoint on the notice or appeal the notice.

(5) A compliance notice shall take effect—

(a) where required, and where the compliance notice so declares, immediately when the notice is received by the person on whom it is served, or

(b) in any other case—

(i) where no appeal is taken, on expiration of the period referred to in paragraph (4), or

(ii) where an appeal is taken, on the next day following the day on which the notice is confirmed on appeal or the appeal is withdrawn or on the expiration of the period referred to in paragraph (4), whichever is the later.

(6) The chief executive of the Authority or another officer of the Authority designated by the chief executive of the Authority for that purpose may, for stated reasons, revoke or vary a compliance notice issued by an authorised officer appointed by the chief executive of the Authority.

(7) In the event of non-compliance with a compliance notice by the person on whom a compliance notice has been served, an authorised officer shall, with the approval of the chief executive of the Authority, or another officer thereof designated by the chief executive of the Authority for that purpose, take whatever measures are considered necessary to ensure compliance with the compliance notice, including the seizure, detention and destruction of the relevant thing or device in question or the making of any arrangements for such seizure, detention and destruction.

(8) This Regulation shall not operate to prevent or restrict—

(a) the entitlement of the Authority to take other action to secure compliance with the EU Regulation and these Regulations by a person, or

(b) the bringing or prosecuting of any proceedings for an offence under these Regulations.

Prohibition order

33. (1) Where the Authority is of the opinion that—

(a) there is non-compliance with a requirement of the EU Regulation,

(b) a device presents an unacceptable risk to the health or safety of patients, users or other persons, or to other aspects of the protection of public health, or

(c) a person has failed to comply with a compliance notice.

the Authority may serve, or arrange to have served, on the person concerned an order (“prohibition order”) in accordance with paragraph (2).

(2) A prohibition order shall—

(a) be signed by the chief executive officer of the authority or another officer thereof authorised for that purpose by the chief executive officer,

(b) state that the Authority is of the opinion that a particular consignment, group, category, batch or lot of the device concerned is not in conformity with the EU Regulation,

(c) specify the provision or provisions of the EU Regulation with which the device is not in compliance and the matters giving rise to the non-compliance,

(d) where relevant, identify the part or parts of the compliance notice with which there has not been compliance, and

(e) direct the person on whom the prohibition order is served to ensure that—

(i) the device is not to be placed on the market, made available on the market or put into service until such time as all appropriate measures, including corrective measures, have been taken to bring the device into conformity with the EU Regulation,

(ii) the placing on the market, making available on the market or putting into service of the device is restricted or made subject to particular requirements,

(iii) the device is prohibited from being placed on the market, made available on the market or put into service

(iv) the device is withdrawn or recalled from the market within a specified time-limit, or

(v) the device is destroyed within a specific time limit and in a manner prescribed by the Authority or is detained for the purposes of destruction by an authorised officer.

(3) The approval referred to in paragraph (1) may be given orally or in writing and if given orally shall be recorded in writing as soon as practicable.

(4) Where appropriate, the Authority shall, without delay, provide a copy of the prohibition order to the person(s) responsible for regulatory compliance of the manufacturer/authorised representative designated in respect of the device concerned, and where necessary any importer(s) or distributor(s).

(5) A prohibition order shall take effect—

(a) where the prohibition order so declares, immediately the order is received by the person on whom it is served, or

(b) in any other case—

(i) where no appeal is taken against the prohibition order, on the expiration of the period during which such an appeal may be taken or the day specified in the prohibition order as the day on which it is to come into effect, whichever is the later, or

(ii) where an appeal is taken, on the day next following the day on which the prohibition order is confirmed on appeal or the appeal is withdrawn or the day specified in the prohibition order as the day on which it is to come into effect, whichever is the later.

(6) The bringing of an appeal against a prohibition order which is to take effect in accordance with paragraph (5)(a) shall not have the effect of suspending the operation of the prohibition order, but the appellant may apply to the Circuit Court to have the operation of the prohibition order suspended until the appeal is disposed of and, on such application, the Circuit Court may, if it thinks it proper to do so, direct that the operation of the prohibition order be suspended until the appeal is disposed of.

(7) In the event of non-compliance by the person on whom the prohibition order has been served, an authorised officer shall, with the approval of the chief executive of the Authority or other officer designated in that behalf by the chief executive of the Authority, take whatever steps are considered necessary to ensure compliance with the direction given under paragraph (2)(e) and this may include the seizure, detention and destruction of the devices in question or the making of any arrangements for such seizure, detention and destruction.

(8) This Regulation shall not operate to prevent or restrict—

(a) the entitlement of the Authority to take other action to secure compliance with the EU legislation and these Regulations by a person, or

(b) the bringing or prosecuting of any proceedings for an offence under these Regulations.

(9) The chief executive of the Authority may, for stated reasons, revoke or vary a prohibition order made in accordance with this Regulation and the Authority shall be notified at the next available meeting of the Authority of any such revocation or variation and the reasons therefore.

(10) Where a prohibition order has been served and activities are carried on in contravention of the prohibition order, the High Court may, on the application of the Authority, by order prohibit the continuance of the activities.

(11) An application to the High Court for an order under paragraph (10) shall be by motion and the Court, when considering the matter, may make such interim or interlocutory order (if any) as it considers appropriate and the order by which an application under paragraph (10) is determined may contain such terms and conditions (if any) as to the payment of costs as the Court considers appropriate.

Appeals from quarantine notices and compliance notices

34. (1) A person may appeal a quarantine notice or compliance notice served on him or her in accordance with appeals procedures provided in guidelines published by the Authority.

(2) The Authority shall inform a person of his or her right of appeal, and the applicable time limits, when serving him or her with a quarantine notice or compliance notice.

(3) A person who is aggrieved by a decision on an appeal under paragraph (1) may appeal that decision to the District Court in the district court district in which the quarantine notice or compliance notice was served, not later than 7 days after the decision concerned.

(4) The bringing of an appeal under this Regulation against a notice which is to take effect immediately on service shall not have the effect of suspending the operation of the notice, but the appellant may apply—

(a) in the case of an appeal under paragraph (1), in accordance with the procedures referred to therein, or

(b) in the case of an appeal under paragraph (3), to the District Court,

to have the operation of the quarantine notice or compliance notice concerned suspended until the appeal is disposed of.

(5) The District Court shall, upon an appeal under paragraph (3), do one of the following:

(a) affirm the notice concerned;

(b) direct the Authority to withdraw the notice concerned; or

(c) direct the Authority to modify the notice concerned.

(6) The Authority shall comply with a direction under paragraph (5)(b) or (c).

(7) Where on the hearing of an appeal under paragraph (3) a notice is affirmed, notwithstanding Regulation 31(7) or 32(5), as applicable, the judge of the District Court by whom the appeal is heard may, on the application of the appellant, suspend the operation of the notice for such period as in the circumstances of the case the district judge considers appropriate.

(8) A person who appeals under paragraph (3) or who applies for a direction under paragraph (7) shall at the same time notify the Authority of the appeal or application and the grounds for the appeal or application and the Authority shall be entitled to appear, be heard and adduce evidence on the hearing of the appeal or application.

(9) A decision of the District Court on an appeal under paragraph (3) shall be final.

Appeals from prohibition orders

35. (1) A person may appeal a prohibition order served on him or her, to the Circuit Court in the circuit in which the order was served, not later than 7 days after the service of the notice or order concerned.

(2) The bringing of an appeal under this Regulation against a prohibition which is to take effect immediately on service shall not have the effect of suspending the operation of the order, but the appellant may apply to the Circuit Court to have the operation of the order suspended until the appeal is disposed of and, on such application, the Court may, if it thinks it proper to do so, direct that the operation of the order be suspended until the appeal is disposed of.

(3) The Circuit Court shall, upon an appeal under this Regulation, do one of the following:

(a) affirm the order concerned;

(b) direct the Authority to withdraw the order concerned; or

(c) direct the Authority to modify the order concerned.

(4) The Authority shall comply with a direction under paragraph (3)(b) or (c).

(5) Where on the hearing of an appeal under this Regulation an order is affirmed, notwithstanding paragraph (5) of Regulation 33, as applicable, the judge of the Circuit Court by whom the appeal is heard may, on the application of the appellant, suspend the operation of the order for such period as in the circumstances of the case the judge considers appropriate.

(6) A person who appeals under this Regulation or who applies for a direction under paragraph (5) shall at the same time notify the Authority of the appeal or application and the grounds for the appeal or application and the Authority shall be entitled to appear, be heard and adduce evidence on the hearing of the appeal or application.

(7) A decision of the Circuit Court on an appeal under this Regulation shall be final, save that, by leave of the Court an appeal from the decision shall lie to the High Court on a specified question of law.

Destruction and disposal

36. Where—

(a) any relevant thing, book, record, document, or premises is detained under this Part, but is not the subject of a prosecution, and

(i) no claim is made for its return within 28 days of notice in writing being given of the intention to destroy or dispose of same, or render same inoperable, or

(ii) the supplier of the relevant thing is not reasonably identifiable, or

(b) a device being supplied at a distance by information society services in contravention of the EU Regulation is detained,

an authorised officer may destroy or dispose of, or render inoperable, such thing, book, record, document, premises or device, in the interest of the protection of public health.

Suspension, restriction and withdrawal of designation of notified bodies

37. Where the Authority has ascertained that a notified body—

(a) no longer meets the applicable requirements set out in the EU Regulation,

(b) is failing to fulfil its obligations, or

(c) has not implemented necessary corrective measures,

the Authority shall suspend, restrict or fully or partially withdraw the notified body’s designation, in accordance with Article 46(4) of the EU Regulation.

Service of notices and orders

38. (1) A notice or order served or given by or under this Part shall be addressed to the person concerned and served or given in one of the following manners:

(a) by addressing it to the person by name and delivering it to him or her;

(b) by leaving it at the address at which the person ordinarily resides or carries on business;

(c) by sending it by post in a prepaid registered letter addressed to the person at the address at which he or she ordinarily resides or carries on business;

(d) if an address for the service of notices has been furnished by the person, by leaving it at, or sending it by prepaid registered post addressed to him or her to, that address;

(e) where the address at which the person ordinarily resides or carries on business cannot be ascertained by reasonable inquiry and notice is required to be served on, or given to, him or her in respect of any premises by delivering it to a person over the age of 16 years resident in or employed on the premises, or by affixing it in a conspicuous position on or near the premises; or

(f) by sending it by means of electronic mail to a device or facility for the reception of electronic mail where such an electronic mail address has been furnished by the person, but only if the sender’s facility for the reception of electronic mail generates a message confirming a receipt of the electronic mail confirming successful transmission of the notice.

(2) Where the name of the person concerned cannot be ascertained by reasonable inquiry, a notice or order under this Part may be addressed to “the occupier”, “the owner” or “the person in charge”, as the case may be.

(3) For the purposes of this Regulation, a company within the meaning of the Companies Act 2014 (No. 38 of 2014) shall be deemed to be ordinarily resident at its registered office, and every other body corporate and every unincorporated body shall be deemed to be ordinarily resident at its principal office or place of business.

(4) A person shall not at any time during the period of 3 months after a notice is affixed under paragraph (1)(e) remove, damage or deface the notice without lawful authority.

PART 5

REVOCATIONS AND TRANSITIONAL PROVISIONS

Revocations

39. The following are revoked:

(a) the Regulations of 1994;

(b) the European Communities (Active Implantable Medical Devices) Regulations 1994 ( S.I. No. 253 of 1994 );

(c) the European Communities (Medical Devices) (Amendment) Regulations 2001 ( S.I. No. 444 of 2001 );

(d) the European Communities (Medical Devices) (Amendment) Regulations 2002 ( S.I. No. 576 of 2002 ), other than Regulation 3 thereof;

(e) the European Communities (Medical Devices) (Tissues of Animal Origin) Regulations 2003 ( S.I. No. 554 of 2003 );

(f) the European Communities (Medical Devices) (Reclassification of Breast Implants) (Amendment) Regulations 2003 ( S.I. No. 358 of 2003 );

(g) the European Communities (Medical Devices) (Reclassification of Hip, Knee and Shoulder Joint Replacements) (Amendment) Regulations 2007 ( S.I. No. 92 of 2007 );

(h) the European Communities (Active Implantable Medical Devices) (Amendment) Regulations 2009 ( S.I. No. 109 of 2009 );

(i) the European Communities (Medical Devices) (Amendment) Regulations 2009 ( S.I. No. 110 of 2009 );

(j) the European Communities (Medical Devices) (Amendment) Regulations 2020 ( S.I. No. 144 of 2020 );

(k) the European Communities (Active Implantable Medical Devices) (Amendment) Regulations 2020 ( S.I. No. 300 of 2020 );

(l) the European Communities (Medical Devices) (Amendment) (No. 2) Regulations 2020 ( S.I. No. 301 of 2020 ).

Transitional provisions

40. (1) Notwithstanding the provisions of these Regulations—

(a) a person is not guilty of an offence by reason of relying upon a certificate issued by a notified body in accordance with Directives 90/385/EEC and 93/42/EEC (other than Annex 4 to Directive 90/385/EEC or Annex IV to Directive 93/42/EEC) prior to 25 May 2017 provided that the period indicated on the certificate has not expired,

(b) until 27 May 2022, a person is not guilty of an offence by reason of relying upon a certificate issued by a notified body in accordance with Annex 4 to Directive 90/385/EEC or Annex IV to Directive 93/42/EEC prior to 25 May 2017 provided that the period indicated on the certificate has not expired,

(c) until 27 May 2024, a person is not guilty of an offence by reason of relying upon a certificate issued by a notified body in accordance with Directives 90/385/EEC and 93/42/EEC on or after 25 May 2017, provided that the period indicated on the certificate has not expired and less than five years have passed since its issuance,

(d) a person is not guilty of an offence by reason of placing on the market or putting into service, on or before 26 May 2024, a device which is a class I device pursuant to Directive 93/42/EEC, for which the declaration of conformity was drawn up prior to 26 May 2021 and for which the conformity assessment procedure pursuant to the EU Regulation requires the involvement of a notified body, or which has a certificate that was issued in accordance with Directive 90/385/EEC or Directive 93/42/EEC and that is valid by virtue of Article 120(2) of the EU Regulation, provided that—

(i) from 26 May 2021 the device continues to comply with either of those Directives,

(ii) there are no significant changes in the design and intended purpose of the device, and

(iii) the requirements of the EU Regulation relating to post-market surveillance, market surveillance, vigilance, registration of economic operators and of devices are complied with in place of the corresponding requirements in those Directives,

(e) until 26 May 2025, a person is not guilty of an offence by reason of making available on the market or putting into service a device lawfully placed on the market pursuant to Directives 90/385/EEC and 93/42/EEC prior to 26 May 2021, or a device placed on the market from 26 May 2021 pursuant to Article 120(3) of the EU Regulation,

(f) a person is not guilty of an offence by reason of placing on the market or putting into service a device manufactured utilising derivatives of tissues or cells of human origin which are non-viable or are rendered non-viable, which device has been legally placed on the market or put into service in accordance with the rules in force in the State prior to 26 May 2021,

(g) a sponsor is not guilty of an offence by reason of the continuance of a clinical investigation which was started in accordance with Article 10 of Directive 90/335/EEC or Article 15 of Directive 93/42/EEC before 26 May 2021, provided that the reporting of serious adverse events and device deficiencies is carried out in accordance with the EU Regulation.

(2) Notwithstanding Regulation 39, until the Eudamed functionality date—

(a) the manufacturer’s undertaking in—

(i) the seventh indent under paragraph 3.1 of Schedule 2,

(ii) paragraph 3 of Schedule 4,

(iii) the eighth indent under paragraph 3.1 of Schedule 5,

(iv) the eighth indent under paragraph 3.1 of Schedule 6, and

(v) paragraphs 4 and 5 of Schedule 7,

to the Regulations of 1994 (as amended by Regulation 29 of the European Communities (Medical Devices) (Amendment) Regulations 2009),

(b) Article 28 (inserted by Regulation 4 of the European Communities (Medical Devices) (Amendment) (No. 2) Regulations 2020) of the Regulations of 1994,

(c) the manufacturer’s undertaking in—

(i) the fifth indent under paragraph 3.1 of Schedule 2,

(ii) paragraph 4 of Schedule 4,

(iii) the sixth indent under paragraph 3.1 of Schedule 5, and

(iv) paragraph 5 of Schedule 6,

to the European Communities (Active Implantable Medical Devices) Regulations 1994 (as amended by Regulation 17 of the European Communities (Active Implantable Medical Devices) (Amendment) Regulations 2009),

(d) Article 22 (inserted by Regulation 4 of the European Communities (Active Implantable Medical Devices) (Amendment) Regulations 2020) of the European Communities (Active Implantable Medical Devices) Regulations 1994

(e) Articles 4(8) and 10, Schedule 6, paragraphs 1, 2.2 and 3.2 and Schedule 7 (as amended by Regulations 14 and 17 of the European Communities (Active Implantable Medical Devices) (Amendment) Regulations 2009) of the European Communities (Active Implantable Medical Devices) Regulations 1994 in relation to notification procedures and the provision and exchange of documentation regarding clinical investigations

(f) Articles 5(8) and 16 and Schedules 8 and 10 (as amended by Regulations 26 and 29 of the European Communities (Medical Devices) (Amendment) Regulations 2009) of the Regulations of 1994,

continue to apply as if they had not been revoked, for the purposes of information and data exchange only, and a person who fails to comply with same is guilty of an offence.

(3) Notwithstanding Regulation 39—

(a) Article 17 (as amended by Regulation 9 of the European Communities (Medical Devices) (Amendment) Regulations 2001) of the Regulations of 1994, and

(b) Article 11 (as amended by Regulation 15 of the European Communities (Active Implantable Medical Devices) (Amendment) Regulations 2009) of the European Communities (Active Implantable Medical Devices) Regulations 1994,

continue to apply, as if they had not been revoked, in respect of—

(i) devices granted CE Marking approval thereunder and made available on the market or put into service up to 27 May 2025, and

(ii) the means by which information is to be exchanged with and notifications to the Authority until Eudamed is functional.

(4) Notwithstanding Regulation 39, as regards the devices referred to in paragraph (1)(d) and (e), the Regulations of 1994 and the European Communities (Active Implantable Medical Devices) Regulations 1994, as amended, continue to apply until 27 May 2025 to the extent necessary for the application of Articles 120(3) and (4) of the EU Regulation, as if those Regulations had not been revoked.

(5) For the purposes of paragraphs (1) to (4), notwithstanding Regulation 39, Regulation 2 of the European Communities (Medical Devices) (Amendment) Regulations 2001 and the enforcement provisions of the Regulations of 1994 and the European Communities (Active Implantable Medical Devices) Regulations 1994, as amended, continue to apply, as if they had not been revoked, for the periods referred to in those paragraphs.

(6) Notwithstanding the provisions of these Regulations, until 6 months after the Eudamed functionality date, the offences in—

(a) Regulation 16(1)(z), (aa), (bb), and (ll),

(b) Regulation 17(e) and (f),

(c) Regulation 19(j) and (k),

(d) Regulation 20(c) and (d)

(e) Regulation 21(p), and

(f) Regulation 25(o),

do not apply, in so far as they apply to using Eudamed as the mechanism for information exchange.

(7) Notwithstanding the provisions of these Regulations, until 18 months after the Eudamed functionality date, the offences in—

(a) Regulation 16(1)(cc) and (dd), and

(b) Regulation 21(r),

do not apply.

(8) Notwithstanding the provisions of these Regulations—

(a) until 26 May 2023, for class IIa and class IIb devices, and

(b) until 26 May 2025, for class I devices,

the offence in Regulations 16(1)(x) does not apply.

(9) Notwithstanding the provisions of these Regulations, with regard to reusable devices that are required to bear the UDI carrier on the device itself—

(a) until 26 May 2023, for implantable devices and class III devices,

(b) until 26 May 2025, for class IIa and class IIb devices, and

(c) until 26 May 2027, for class I devices,

the offence in Regulation 16(1)(x) does not apply.

(10) In this Regulation—

“Directive 90/385/EEC” means Council Directive 90/385/EEC of 20 June 19908 ;

“Directive 93/42/EEC” means Council Directive 93/42/EEC of 14 June 19939 ;

“Eudamed functionality date” means the date of publication of the notice referred to in Article 24(3) of the EU Regulation.

/images/ls

GIVEN under my Official Seal,

25 May, 2021.

STEPHEN DONNELLY,

Minister for Health.

EXPLANATORY NOTE

(This note is not part of the Instrument and does not purport to be a legal interpretation.)

These Regulations—

- confer functions on the Health Products Regulatory Authority in relation to medical devices,

- lay down requirements for health institutions in relation to making information available to patients who have been implanted with implantable devices,

- set out the national position with regard to reprocessing of single-use devices to make them suitable for further use,

- provide for various matters in relation to clinical investigations of medical devices, and

- provide offences for breaches of the requirements of Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 and provisions herein.

- These Regulations may be cited as the Medical Devices Regulations 2021.

1 OJ No. L 117, 5.5.2017, p. 1.

2 OJ No. L 130, 24.4.2020, p. 18.

3 OJ No. L 218, 13.8.2008, p. 30.

4 OJ No. L 169, 25.6.2019, p. 1.

1 OJ No. L 117, 5.5.2017, p. 1.

2 OJ No. L 130, 24.4.2020, p. 18.

5 OJ No. L 241, 17.9.2015, p. 1.

4 OJ No. L 169, 25.6.2019, p. 1.

3 OJ No. L 218, 13.8.2008, p. 30.

6 OJ No. L 210, 7.8.1985, p. 29.

7 OJ No. L 210, 7.8.1985, p. 29.

8 OJ No. L 189, 20.7.1990, p. 17.

9 OJ No. L 169, 12.7.1993, p. 1.