The EU MDR came into force on the 25th of May 2017. Since the 26th of May 2021, new devices and devices without a valid MDD/AIMDD certificate are required to meet MDR requirements. In December, the EU Health Commissioner proposed key changes to the current MDR framework. The Commission has now formalized Kyriakides’ plan. The proposal now moves to the European Parliament and Council for adoption.
European council members stated that they are concerned there isn’t enough capacity to handle all the thousands of outstanding conformity assessments that must be completed before the transitional period provided in Article 120(3) of the regulation expires and fear the current deadlines could trigger widespread shortages if left in place. Therefore, the members expressed support for the proposal by the European Commission to delay the transitional deadlines for medical devices under the MDR.
Key Changes included in the proposal
The European Union Health Commissioner has proposed delaying enforcement of the Medical Devices Regulation (MDR) by three to four years to prevent product shortages. This brings the new deadline to 2027 for high-risk class III and class IIb devices and to 2028 for medium class IIa and low-risk I devices.
Commissioner Stella Kyriakides also believes that the delays “must be accompanied by additional measures to address the structural problems of the Regulation”, including the need for targeted solutions to the problems facing rare disease devices.
The Health Commissioner also proposed removing the “sell-off” date requiring marketed medical devices to be discarded in May 2025 under both MDR and the In Vitro Diagnostic Devices Regulation (IVDR). Would also like to prioritize orphan devices being able to stay on the market to avoid interrupting patient access.
Why is there a need for an extension?
MedTech Europe stated that the medical device industry welcomes the Commission’s recognition of the ongoing urgent risks of medical device shortages in Europe, stemming from Medical Devices Regulation implementation challenges. These proposed changes could help the critical medical device shortage that the medical industry is facing in Europe.
The above-mentioned key proposals are unchanged from the statement Kyriakides made last month. In a proposal to the European Parliament and the Council, the Commission set out plans to extend the transition period for higher-risk devices until the end of 2028. The Commission also plans to remove the “sell-off” date that would force the unnecessary disposal of some safe medical devices. Manufacturers of class III implantable custom-made devices have until May 26, 2026, to obtain certification by a notified body under the draft MDR amendments. This means that they must start the notified body process by May 26, 2024.
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