EC Proposal to delay MDR: which provisions are affected?

The European Commission proposal for the MDR delay is now officially published and accessible through: https://ec.europa.eu/commission/presscorner/detail/en/ip_20_589

Proposal for a Regulation of the European Parliament and of the Council amending Regulation (EU) 2017/745 on medical devices as regards the dates of application of certain of its provisions modifies current MDR provisions as follows:

• Article 1(2): Necessary common Specifications for Annex XVI devices shall be adopted by 26 May 2021 instead of 26 May 2020 + 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+ same modification in the event they are not adopted by 26 May 2021
• Article 17 (6): Placing of single-use devices on the market that were reprocessed before 26 May 2021 (instead of 26 May 2020)
• Article 34 (1): European Commission notice on EUDAMED full functionality: 25 March 2021 instead of 25 March 2020
• Article 59: Significant amendment of derogation clause:

”By way of derogation from Article 52 of this Regulation or, for the period from [insert date – date of entry into force of this Regulation] 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.’’

”1. 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 [insert date – date of entry into force of this Regulation].’,

2. 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 [insert date – date of entry into force of this Regulation], 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(4) is replaced by following:

”Devices lawfully placed on the market pursuant to Directives 90/385/EEC and 93/42/EEC prior to 26 May 2021 (instead of May 2020, MDlaw note), 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), (11) : clinical investigations, special devices with non-viable tissues, cells:  prior to 26 May 2021 instead of 26 May 2020
• Article 122: 26 May 2020 replaced by 26 May 2021. and added paragraph:

“– Article 11(13) of Directive 93/42/EEC and Article 9(9) of Directive 90/385/EEC which are repealed with effect from [insert date – date of entry into force of this Regulation]”;

• Article 123 (2): It shall apply from 26 May 2021 (instead of 26 May 2020)
• Article 123(3) points (a), (d): Notified Body obligations A35-50…until 26 May 2021, if not fully functional EUDAMED on 26 May 2021 (instead of 26 May 2020)
• Article 123 (3) point (f) is replaced by the following:

”Article 27(4) shall apply to class IIa and class IIb devices from 26 May 2023 and to class I devices from 26 May 2025;”

• Article 123(3) point (g) is replaced by the following:

”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

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

”Article 59 shall apply from [insert date – date of entry into force of this Regulation]’;

• 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).

We did not notice any amendment/extension to the transition provisions for validity of Certificates – 120(2).

Deadline for making available of MDD compliant devices on the EU market is 26 May 2025 (original MDR text: 27 May 2025) .

As previously mentioned on this Platform, we will need to wait to see whether the Council and the Parliament adopt this Proposal, which shall be done through an accelerated co-decision procedure. We will keep you informed through our News section!