The European Commission’s Proposal to amend the transitional provisions of the EU Medical Devices Regulation (MDR) and the In Vitro Diagnostic Medical Devices Regulation (IVDR) has now been formally adopted by the Council of the European Union.
The amendment will help mitigate the immediate risk that medical devices across all areas of medicine, which are still on the EU market, would no longer be available after May 2024.
Stella Kyriakides, Commissioner for Health and Food Safety, welcomed the move, commenting:“I would like to express my gratitude to the European Parliament, the Council, and the Swedish Presidency in particular for swiftly agreeing on our proposal to extend the transitional periods of the Medical Devices Regulation. This is an important step that will help address the short-term difficulties Member States are facing and ensure a continued access to needed medical devices for patients in the EU.”
“The amendment of the Medical Devices Regulations’ transitional provisions is a needed step forward to help ensure that more medical devices remain available to patients and healthcare systems across Europe. This decision grants Notified Bodies more time to complete certification of more than 500,000 medical devices and accelerates efforts to certify innovative devices in the pipeline,” says Oliver Bisazza, CEO of MedTech Europe.
As soon as the amendment comes into force, MedTech Europe and its members will work toward its implementation according to the new provisions and extended deadlines. In that regard, it is important that all stakeholders have an aligned and clear interpretation of the amendment, including the process for submitting applications to Notified Bodies, and how the extended validity of certificates can be concretely demonstrated.
Looking ahead, MedTech Europe calls on the European Commission, Member States, and Notified Bodies to solve the remaining MDR and IVDR implementation and governance challenges to ensure that medical devices and IVDs are certified and made available to patients in a timely, efficient, and predictable manner.
Clear regulatory pathways are needed for strengthening the role of Europe as an attractive region for research, development, and launch of needed medical technology innovation. These include – but are not limited to – orphan devices and niche devices that risk disappearing from the EU market due to the current state of MDR implementation.