Europe’s new Medical Device Regulation Delayed by One Year
The new European medical devices legislation, MDR, should replace the current Medical Devices Directive from May 26, 2020. However, as a result of a lack of designated Notified Bodies, coupled with Brexit and COVID-19 pandemic the EU has proposed a one-year delay to the Date of Application.
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The Medical Devices Directive 93/42/EEC was formulated 30 years ago. It has been given facelifts during the intervening years, but inevitably a major overhaul was needed. The famous PIP scandal, with poor quality breast implants, was the final straw.
After years of negotiations the Medical Devices Regulation 2017/745 was approved and entered into force in May 2017. The legislation tried to meet every wish, address Unionwide common interpretation of the law, facilitate stronger controls over notified body activities and improve traceability of medical devices through application of the UDI and EUDAMED databases. The Date of Application (DoA) for MDR was set for May 26, 2020 and the MDD was finally to be replaced.
Are we ready for MDR?
Almost three years has passed since the MDR was approved, and Europe is still not ready. Part of the implementing acts, common specifications and guidance documents needed for efficient implementation of MDR are still missing. EUDAMED is not ready to be applied as the center of information exchange and a lack of designated notified bodies is stopping manufacturers (most of which are not prepared yet) from receiving their MDR EC certificates.
Every medical device trade organization has appealed to the European Commission to delay the DoA, to give all stakeholders more time to prepare for the complicated change. To date, the Commission response has always been the same: Everything is going smoothly and there is no reason for an extended transition time.
Extension to the MDR transition time?
Everything was presented as fine, before Brexit and the COVID-19 pandemic. Removing UK-based notified bodies from the system will invalidate about 30% of pre-Brexit MDD EC certificates and coronavirus is exhausting the already strained resources of national authorities and notified bodies. The Commission has acknowledged the issues and on April 3, 2020 the Commission published a proposal to the European Parliament and the Council to effectively move the DoA forward by one year.
Unfortunately, the proposal appeared not to notice that there had been two Corrigenda to the MDR, effectively modifying transition times for devices that would move to a higher risk class on the DoA.
The General Secretariat of the Council took note of the omission and on April 7, 2020 prepared a modified proposal as a mandate for negotiations with the European Parliament. In the updated proposal, all relevant dates tied to the original DoA have been moved forward by one year.
The European Parliament has voted with an urgent procedure for the extension in its plenary meeting on April 17, 2020. Result: 693 in favor, 1 against. It is now almost certain that the proposal will be approved.
Because of the urgent procedure, there will not be a second vote. After the European Economic and Social Committee and the Committee of Regions are consulted, the Council can approve the change to be published in the Official Journal, hopefully before the DoA, May 26, 2020.
Once the OJ publication is complete, all MDD notified bodies will be able to continue to work as before for one more year, performing initial certifications, re-certifications and extensions to the approved scope of certificates. No up-classification will take place before May 26, 2021 and the Commission may be ready to announce, in 2021, that the EUDAMED is functional.
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