S.I. No. 300/2020 - European Communities (Active Implantable Medical Devices) (Amendment) Regulations 2020
Notice of the making of this Statutory Instrument was published in | ||
“Iris Oifigiúil” of 14th August, 2020. | ||
I, Stephen Donnelly, Minister for Health, in exercise of the powers conferred on me by section 3 of the European Communities Act 1972 (No. 27 of 1972) and for the purpose of giving further effect to Council Directive 90/385/EEC of 20 June 19901 and Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 20172 , as amended by Regulation (EU) 2020/561 of the European Parliament and of the Council of 23 April 20203 , hereby make the following regulations: | ||
1. (1) These Regulations may be cited as the European Communities (Active Implantable Medical Devices) (Amendment) Regulations 2020. | ||
(2) The Principal Regulations, Regulations 2(3) and 20 of the European Communities (Medical Devices) (Amendment) Regulations 2001 ( S.I. No. 444 of 2001 ), the Regulations of 2009 and these Regulations may be cited together as the European Communities (Active Implantable Medical Devices) Regulations 1994 to 2020 and shall be construed together as one. | ||
2. In these Regulations— | ||
“Principal Regulations” means the European Communities (Active Implantable Medical Devices) Regulations 1994 ( S.I. No. 253 of 1994 ); | ||
“Regulations of 2009” means the European Communities (Active Implantable Medical Devices) (Amendment) Regulations 2009 ( S.I. No. 109 of 2009 ). | ||
3. Article 7(5) of the Principal Regulations is amended by substituting “public health or patient safety or health” for “protection of health”. | ||
4. The Principal Regulations are amended by inserting after Article 21 the following Article: | ||
“Information on incidents occurring following placing of devices on market | ||
22. (1) The Competent Authority shall record and evaluate any information brought to its attention regarding the following incidents involving a device: | ||
(a) any malfunction of or deterioration in the characteristics and performances of a device, as well as any inadequacy in the labelling or in the instructions for use which might lead to or might have led to the death of a patient or user or to a serious deterioration in his or her state of health; and | ||
(b) any technical or medical reason in relation to the characteristics or performances of a device for the reasons referred to in paragraph (a), leading to systematic recall of devices of the same type by the manufacturer. | ||
(2) After carrying out an assessment, if possible together with the manufacturer or his or her authorised representative, the Competent Authority shall, without prejudice to Article 13(A), immediately inform the Commission and the other Member States of measures that have been taken or are contemplated to minimise recurrence of the incidents referred to in subarticle (1), including information on the underlying incidents.”. | ||
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GIVEN under my Official Seal, | ||
6 August, 2020. | ||
STEPHEN DONNELLY, | ||
Minister for Health. | ||
EXPLANATORY NOTE | ||
(This note is not part of the Instrument and does not purport to be a legal interpretation.) | ||
The purpose of these Regulations is to give effect to Regulation 59(1) of Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017, as amended by Regulation (EU) 2020/561 of the European Parliament and of the Council of 23 April 2020. In addition, these Regulations implement Article 8 of Council Directive 90/385/EEC of 20 June 1990 in the State. | ||
These Regulations amend the European Communities (Active Implantable Medical Devices) Regulations 1994. | ||
These Regulations may be cited as the European Communities (Active Implantable Medical Devices) (Amendment) Regulations 2020. | ||
1 OJ No. L 189, 20.7.1990, p. 17. |
