On 13-14 March 2023, Ministers of Health of European Member States discussed, among others, the issue of medical devices.
The Commission provided an update on the implementation of the medical devices regulations and the presidency, together with the Commission, informed delegations about the negotiations for an international agreement on pandemic prevention, preparedness and response.
In its policy brief, the European Commission notably outlined that 38 notified bodies have been designated under the MDR. This is two more than on 9 December 2022. Further 26 applications for designation as notified body are currently being processed; 7 of them are in an advanced stage. The Commission has called upon all actors involved in the assessment, designation and notification of conformity assessment bodies to make all efforts to speed up this process, while preserving the level of requirements to be met by notified bodies under the Regulations.
In its brief, the Commission presented the forthcoming actions, namely:
- Gain momentum in designation of notified bodies
- Continue the implementation of actions to enhance notified body capacity and ensure availability of medical devices and in vitro diagnostics
- Support EMA’s Pilot project on scientific advice for clinical development strategies for high-risk devices
- Increase support for SMEs
- Provide tailored solutions for orphan devices
- Ensure financial support through the EU funded programmes
For more information, visit the Council’s EPSCO page and the Swedish EU Presidency page
