On 16 February 2023, the European Parliament voted at first reading 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”). The proposed text was adopted without any amendments. The approved amendment will not introduce substantive revisions to the quality, safety, and performance requirements established in the MDR and the IVDR. It will, however, give medical device manufacturers additional time to bring their devices into conformity with the requirements foreseen in the Regulations. It will also allow more time for notified bodies to conduct conformity assessment procedures in accordance with the Regulations.

Following pressure from the medical device industry and from the EU Member States, the European Parliament approved the European Commission’s proposal to:

  1. extend the transitional periods foreseen in the MDR for certain devices certified in accordance with the Medical Devices Directive 93/42/EEC (“MDD”) and the Active Implantable Devices Directive 90/385/EEC (“AIMDD”) on the basis of the risk classification of each device;
  2. prolong the validity of CE certificates of conformity issued in accordance with the MDD, AIMDD and the In Vitro Medical Devices Directive 98/79/EEC (“IVDD”) prior to 26 May 2021; and
  3. allow medical devices and IVDs certified in accordance with the MDD, AIMDD and IVDD that are on the market to continue to be sold beyond the “sell-off” deadline of May 2025. (For more information on the European Commission’s proposal, please refer to Cooley’s related Cooley Alert)

The amendment to the transitional provisions in the MDR and the IVDR was adopted in accordance with the urgent procedure. A related request was approved by the European Parliament two days before the plenary vote on the substance of the legislative amendment. The European Commission’s proposal provides that the urgency of the measure is justified by the “imminent risk of shortages of medical devices and the associated risk of a public health crisis”. The urgency to adopt this amendment was also expressed by health ministers of the EU Member States in the meeting of the Employment, Social Policy, Health and Consumer Affairs Council (“EPSCO”) in December 2022 (for more information on the EPSCO meeting, please refer to Cooley’s related Productwise blog) and has been sustained throughout the legislative process, with the European Commission’s proposal being available for stakeholder feedback for only 8 days

Next steps

The text approved by the European Parliament will now be subject to an official adoption procedure by the Council of the European Union (“Council”). The text has already been reviewed and agreed by the Permanent Representatives Committee (“Coreper”), the body responsible for preparing and coordinating the Council’s work items. It will, however, require formal adoption by the Council. The European Parliament’s position was discussed by the Council on Friday 17 February 2023 and is expected to be formally approved early in the week of 20 February 2023. After formal adoption by the Council, the amended Regulation will be published in the Official Journal of the European Union.

In addition to the approved legislative amendments, the European Commission has announced its intention to carry out a comprehensive assessment of the MDR by May 2027. The purpose of the assessment will be to identify structural problems with the MDR and examine potential solutions to these issues. The European Commission also intends to fund actions to support the implementation of the MDR, including in relation to notified body capacity and orphan medical devices. These actions will be funded under the EU4Health programme starting in early 2023.

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

Posted by Cooley