The European Union is taking several measures to address concerns regarding the safety and performance of medical devices in the market. There have been fears of a shortage of medical devices due to expiring certificates, as well as a lack of overall capacity among the notified bodies designated under the Medical Devices Regulation (MDR).
To address these concerns, the EU has established several guiding principles, including ensuring patient access to a wide range of safe devices and giving more time to manufacturers to transition to MDR.
To implement these principles, the EU has taken both legislative and non-legislative actions.
The Commission has proposed an extension of the transition period, along with the extension of the validity of certificates for certain medical devices. The EU is also providing financial support through the EU4Health programme, and is undertaking market surveys to monitor implementation progress.
In addition to these measures,
the EU is taking non-legislative actions to enhance the capacity of notified bodies and ensure the availability of medical devices. This includes ongoing work to designate more notified bodies, as well as targeted support for small and medium-sized enterprises (SMEs) through the Enterprise Europe Network.
Pilot scientific advice to manufacturers:
The European Medicines Agency (EMA) is also undertaking a pilot project to offer scientific advice to manufacturers of high-risk medical devices such as class III and class IIb active medical devices.
The EMA will start accepting letters of interest from companies interested in the pilot program at the end of February Letter of interest template for online application (europa.eu).
This project will provide manufacturers with guidance on their intended clinical development strategies and proposals for clinical investigation, helping to ensure that safe and effective medical devices are available to patients.
In conclusion, the EU is taking a comprehensive approach to address the concerns surrounding medical devices, with a focus on ensuring patient safety and ensuring the availability of safe and effective medical devices.
Reference: Information session on the pilot for expert panels’ scientific advice to manufacturers of high-risk medical devices | European Medicines Agency (europa.eu)