Legal provisions of COM(2020)144 - Amendment of Regulation (EU) 2017/745 on medical devices as regards the dates of application of certain of its provisions

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dossier COM(2020)144 - Amendment of Regulation (EU) 2017/745 on medical devices as regards the dates of application of certain of its provisions.
document COM(2020)144 EN
date April 23, 2020

Contents

Article 1

Regulation (EU) 2017/745 is amended as follows:

(1)in Article 1(2), the second subparagraph is amended as follows:

(a)in the first sentence, the date ‘26 May 2020’ is replaced by ‘26 May 2021’;

(b)in the second sentence, the date ‘26 May 2020’ is replaced by ‘26 May 2021’;

(2)Article 17 is amended as follows:

(a)paragraph 5 is amended as follows:

(i)in the first sentence, the date ‘26 May 2020’ is replaced by ‘26 May 2021’;

(ii)in the third sentence, the date ‘26 May 2020’ is replaced by ‘26 May 2021’;

(b)in paragraph 6, the date ‘26 May 2020’ is replaced by ‘26 May 2021’;

(3)in Article 34(1), the date ‘25 March 2020’ is replaced by ‘25 March 2021’;

(4)Article 59 is amended as follows:

(a)paragraph 1 is replaced by the following:

‘1.By way of derogation from Article 52 of this Regulation or, for the period from 24 April 2020 to 25 May 2021, by way of derogation from Article 9(1) and (2) of Directive 90/385/EEC or from Article 11(1) to (6) of Directive 93/42/EEC, any competent authority may authorise, on a duly justified request, the placing on the market or putting into service within the territory of the Member State concerned, of a specific device for which the applicable procedures referred to in those Articles have not been carried out but use of which is in the interest of public health or patient safety or health.’;

(b)in paragraph 2, the following subparagraph is added:

‘The Member State may inform the Commission and the other Member States of any authorisation granted in accordance with Article 9(9) of Directive 90/385/EEC or Article 11(13) of Directive 93/42/EEC before 24 April 2020.’;

(c)in paragraph 3, the first subparagraph is replaced by the following:

‘Following a notification pursuant to paragraph 2 of this Article, the Commission, in exceptional cases relating to public health or patient safety or health, may, by means of implementing acts, extend for a limited period of time the validity of an authorisation granted by a Member State in accordance with paragraph 1 of this Article or, when granted before 24 April 2020, in accordance with Article 9(9) of Directive 90/385/EEC or Article 11(13) of Directive 93/42/EEC to the territory of the Union and set the conditions under which the device may be placed on the market or put into service. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 114(3).’;

(5)in Article 113, the date ‘25 February 2020’ is replaced by ‘25 February 2021’;

(6)Article 120 is amended as follows:

(a)in paragraph 1, the date ‘26 May 2020’ is replaced by ‘26 May 2021’;

(b)in paragraph 3, the first subparagraph is replaced by the following:

‘3.By way of derogation from Article 5 of this Regulation, 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 this 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 paragraph 2 of this Article, may be placed on the market or put into service until 26 May 2024, provided that from 26 May 2021 it continues to comply with either of those Directives, and provided there are no significant changes in the design and intended purpose. However, the requirements of this Regulation relating to post-market surveillance, market surveillance, vigilance, registration of economic operators and of devices shall apply in place of the corresponding requirements in those Directives.’;

(c)paragraph 4 is replaced by the following:

‘4.Devices lawfully placed on the market pursuant to Directives 90/385/EEC and 93/42/EEC prior to 26 May 2021, and devices placed on the market from 26 May 2021 pursuant to paragraph 3 of this Article, may continue to be made available on the market or put into service until 26 May 2025.’;

(d)in paragraph 5, the date ‘26 May 2020’ is replaced by ‘26 May 2021’;

(e)paragraph 6 is replaced by the following:

‘6.By way of derogation from Directives 90/385/EEC and 93/42/EEC, conformity assessment bodies which comply with this Regulation may be designated and notified prior to 26 May 2021. Notified bodies which are designated and notified in accordance with this Regulation may carry out the conformity assessment procedures laid down in this Regulation and issue certificates in accordance with this Regulation prior to 26 May 2021.’;

(f)paragraph 10 is replaced by the following:

‘10.Devices falling within the scope of this Regulation in accordance with point (g) of Article 1(6) which have been legally placed on the market or put into service in accordance with the rules in force in the Member States prior to 26 May 2021 may continue to be placed on the market and put into service in the Member States concerned.’;

(g)paragraph 11 is amended as follows:

(i)in the first sentence, the date ‘26 May 2020’ is replaced by ‘26 May 2021’;

(ii)in the second sentence, the date ‘26 May 2020’ is replaced by ‘26 May 2021’;

(7)in Article 122, the first paragraph is amended as follows:

(a)in the introductory part, the date ‘26 May 2020’ is replaced by ‘26 May 2021’;

(b)the following indent is added:

‘—Article 9(9) of Directive 90/385/EEC and Article 11(13) of Directive 93/42/EEC, which are repealed with effect from 24 April 2020.’;

(8)Article 123 is amended as follows:

(a)in paragraph 2, the date ‘26 May 2020’ is replaced by ‘26 May 2021’;

(b)paragraph 3 is amended as follows:

(i)in point (a), the date ‘26 May 2020’ is replaced by ‘26 May 2021’;

(ii)in the first sentence of point (d), the date ‘26 May 2020’ is replaced by ‘26 May 2021’;

(iii)point (g) is replaced by the following:

‘(g)with regard to reusable devices that are required to bear the UDI carrier on the device itself, Article 27(4) shall apply to:

(i)implantable devices and class III devices from 26 May 2023;

(ii)class IIa and class IIb devices from 26 May 2025;

(iii)class I devices from 26 May 2027;’;

(iv)the following point is added:

‘(j)Article 59 shall apply from 24 April 2020.’;

(9)in point (h) of Section 5.1 of Annex IX, the date ‘26 May 2020’ is replaced by ‘26 May 2021’.

Article 2

This Regulation shall enter into force on the day of its publication in the Official Journal of the European Union.

This Regulation shall be binding in its entirety and directly applicable in all Member States.