On 7 March 2023, the Council of the EU (“Council”) approved at first reading the European Commission’s proposal, supported by the European Parliament, to amend the transitional provisions in Regulation (EU) 2017/745 on medical devices (“MDR”) and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (“IVDR”). All 27 members of the Council, representing the 27 EU Member States, voted in favor of the proposed legislative amendment during a session of the Education, Youth, Culture and Sports Council.

As discussed in our previous blog post, the related amendment was proposed by the European Commission in response to the imminent risk of medical device shortages on the EU market resulting from the limited capacity and availability of notified bodies and the insufficient preparedness of device manufacturers to bring their devices into conformity with the Regulations within the original transition timelines. The amendment will not introduce any substantive revisions to the requirements established in the Regulations. It will, however, postpone the timeline within which manufacturers of certain medical devices certified in accordance with Directive 93/42/EEC on medical devices (“MDD”) and Directive 90/385/EEC on active implantable devices (“AIMDD”) will be required to comply with the requirements established in the MDR.

The extension of the transitional periods in the MDR will follow a staggered approach based on the risk classification of each device and will be subject to cumulative conditions. These conditions are intended to ensure that only devices that are safe and for which the necessary actions have been taken to facilitate their transition to the requirements established in the MDR benefit from this extension.

Specifically, the legislative amendment will allow certain medical devices that are certified in accordance with the MDD and the AIMDD prior to 26 May 2021 – so called “legacy” devices – to be placed on the EU market or put into service until:

  • 31 December 2027 for Class III and Class IIb implantable devices[1];
  • 31 December 2028 for Class IIb, Class IIa and Class I devices placed on the market in sterile condition or having a measuring function; and
  • 26 May 2026 for Class III custom-made implantable devices provided that an application for conformity assessment has been lodged before or on 26 May 2024 and a written agreement has been signed by the notified body and the manufacturer before or on 26 September 2024.

The validity of the CE Certificates of Conformity for legacy devices benefitting from one of the above transitional periods will also be prolonged based on the risk class of each device.

The legislative amendment will also allow medical devices and IVDs covered by a CE Certificate of Conformity issued in accordance with the MDD, AIMDD or Directive 98/73/EC on in vitro diagnostic medical devices (“IVDD”) before 26 May 2021 to continue to be sold on the EU market. Removing the “sell-off” deadline in the MDR and the IVDR will prevent safe medical devices that have already been placed on the EU market but have not yet reached the final user from being withdrawn.

The medical device industry has welcomed the adoption of the extended transitional periods by the European Parliament and Council and the removal of the “sell-off” deadline. Med Tech Europe, the trade association representing the EU medical device industry, has, however, called for “aligned and clear interpretation of the amendment”. This includes a streamlined submission process for conformity assessment by notified bodies and guidance on the type of evidence needed to demonstrate that the validity of CE Certificates of Conformity has been extended.

Formal adoption of the European Commission proposal by the European Parliament and the Council will take place on 15 March 2023 with the signature of the legislative act by the Presidents of the two bodies. The amended Regulation will then enter into force the day of its publication in the Official Journal of the European Union.

This blog was authored by Elizabeth Anne Wright and Anastasia Vernikou.

[1] The following devices do not benefit from the extended transitional period: sutures, staples, dental fillings, dental braces, tooth crowns, screws, wedges, plates, wires, pins, clips and connectors.

Posted by Cooley