On the 25th of May 2016, the Netherlands Presidency of the Council of the European Union and representatives of the European Parliament agreed new rules for evaluation and market access of medical devices and in vitro diagnostic medical devices. Now, the Council’s Permanent Representatives Committee will be invited to endorse the agreement probably by mid-June 2016. After their legal-linguistic revision, the new regulations will have to be approved by the Council and the European Parliament. They will apply three years after publication as regards medical devices and five years after publication as regards in vitro diagnostic medical devices.
The agreement reached seeks to ensure the safety of medical devices by strengthening the rules on placing devices on the market and tightening surveillance once they are available. The agreement will further tighten the rules for the independent bodies that are responsible for assessing medical devices before they can be placed on the market. The new rules will strengthen the surveillance of these so-called notified bodies by national authorities. They will also give them the right and duty to carry out unannounced factory inspections. Notified bodies will have to ensure that they have available qualified personnel. The draft regulations establish explicit provisions on manufacturers’ responsibilities for the follow-up of the quality, performance and safety of devices placed on the market. The new texts also improve the availability of clinical data on devices. The protection of patients participating in clinical investigations will also be strengthened.
To safeguard patients’ safety, certain high risk devices, such as implants, may undergo an additional check by experts before they are placed on the market. A central database will be set up to create an improved system for all relevant information. It will provide patients, healthcare professionals and the public with comprehensive information on products available in the EU. This will enable them to make better informed decisions. Patients who are implanted with a device will be given key information on the product, including any precautions which might need to be taken. Devices will also have a unique identification number to provide for traceability throughout the supply chain to the end-user or patient.
EFA has been advocating for a regulation that improves transparency and patients’ involvement in development and evaluation of devices, like we are at the level of the European Medicines Agency, as well as strengthened patients’ safety. Together with the European Patients’ Forum (EPF) we have been asking for the voice of patients to be heard and we are pleased to see that at least some of our concerns have been taken on board by the institutions.