During a plenary debate in Strasbourg on Wednesday 9 October, a majority of MEPs called for a rapid revision of the regulations on medical devices (see EUROPE 13420/8).
“I understand the calls for an urgent review of the regulations on medical devices. However, having worked together on the extension of the transitional periods, I would strongly caution against a hasty initiative. We must do the right thing on the basis of data and analysis, with the necessary involvement of all the stakeholders concerned”, replied Věra Jourová, Vice-President of the Commission.
The process of targeted evaluation has already begun, and it is important to “gather the data and points of view required for an in-depth evaluation”, the institution added. In line with the political indications of the President, Ursula von der Leyen, the Commissioner-designate for Health will give priority to evaluation and any necessary follow-up action.
The EU recently amended the regulations on medical devices (implants, surgical tools, inhalers) and in vitro diagnostics. “Extended transition periods were essential to avoid shortages of devices”, said Ms Jourová. However, the Commission acknowledged that these measures alone do not constitute a sustainable long-term solution. “We have already taken preparatory measures ahead of the legal deadline of May 2027 to assess the existing European rules and remedy any shortcomings”. The Commission is currently gathering the necessary data and intends to open a call for contributions and a public consultation by the end of 2024.
Peter Liese (EPP, German) has received information that a proposal may be submitted in 2026. “It’s too late. We need a concrete proposal within 100 days of the new Commission taking office”, he said. Andreas Glück (Renew Europe, German) also called for the rules to be adapted: “We need a workable solution for orphan devices and paediatric surgery, and the abolition of the additional five-year certification for low-risk products. We need sufficient capacity in terms of notified bodies and fast track authorisations for innovative products”. (Original version in French by Lionel Changeur)