MDR Delay: which provisions have been changed?

The  postponement of the entering into force of MDR delay to 26 May 2021 has been published on 24.04.2020 with its publication in the Official Journal of the European Union - Regulation (EU) 2020/561 of the European Parliament and of the Council of 23 April 2020 amending Regulation (EU) 2017/745 on medical devices, as regards the dates of application of certain of its provisions. Check below the concerned disposition:

  • Article 1 (2): Necessary common Specifications for Annex XVI devices shall be adopted by 26 May 2021 instead of 26 May 2020 and shall apply as from six months after the date of their entry into force or from 26 May 2021, whichever is the latest;
  • Article 17 (5): Common Specification for reprocessed single-use devices shall be adopted by 26 May 2021 instead of 26 May 2020 and reprocessing should be carried out according to national provision and available harmonized standards in the event they are not adopted by 26 May 2021;
  • Article17 (6): Only single-use devices that have been placed on the market in accordance with this Regulation, or prior to 26 May 2021 (instead of 26 May 2020) in accordance with Directive 93/42/EEC, may be reprocessed;
  • Article 34 (1): European Commission notice on EUDAMED full functionality expected now on 25 March 2021 instead of 25 March 2020;
  • Article 59: Significant amendment of derogation clause:

Par. 1 has been amended as follows: ‘‘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’’;

Par. 2 has been amended as follows: ‘‘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’’;

Par. 3 has been amended as follows: ‘‘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)’’;


  • Article 113:  Member States notifying of the implementation of penalties to the European Commission: 25 February 2021 instead of 25 February 2020;
  • Article 120(1): Notification in respect of Notified Body to become void: from 26 May 2021 instead of 26 May 2020;
  • Article 120(3) is replaced by the following:

‘‘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 2021and 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’’;

  • Article 120(4) is replaced by following:

‘‘sDevices 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”;

  • Article 120 (5): Compliant MDR devices can be placed on the market prior to 26 May 2021 (instead of 26 May 2020);
  • Article 120 (6): Notified body designations and issuance of MDR certificates prior to 26 May 2021 (instead of 26 may 2020);
  • Article 120 (10)has been replaced by the following: ‘‘Devices falling within the scope of this Regulation in accordance with point (g) of Article 1(6) {transplants, tissues or cells of human origin, or their derivatives} 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;
  • Article 120(11):Clinical investigations which have started to be conducted in accordance with to 26 May 2021 may continue to be conducted. As of 26 May 2021, however, the reporting of serious adverse events and device deficiencies shall be carried out in accordance with this Regulation;
  • Article 122 (repeal): 26 May 2020 replaced by 26 May 2021;

And added paragraph:

“– 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”;

  • Article 123 (2) (date of application):It shall apply from 26 May 2021(instead of 26 May 2020);
  • Article 123(3) points (a): From 26 May 2021, Notified Body obligations from Articles 35-50 of the MDR to apply to NB under MDR designation process;
  • Article 123(3) point (d): EUDAMED is not fully functional on 26 May 2021 (instead of 26 May 2020), the obligations that relate to it shall apply from the date corresponding to six months after the date of the European Commission publication of the notice on EUDAMED functionality in the Official Journal of the EU;
  • Article 123(3) point (g) is replaced by the following:

“With regard to reusable devicesthat 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’’;

  • Article 123 (3) the following point (j) is added:

“Article 59 shall apply from 24 April 2020’’;

  • Annex IX, Section 5.1. (h): The Commission to provide guidance for expert panels for consistent interpretation of criteria (point c of same section) before 26 May 2021 (instead of 26 May 2020);

29.04.2020

Francesca Zuccarello, Ajda Mihelcic

Publishing Department


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