The new Medical Devices Regulation will include tightened rules on placing devices on the market as well as surveillance once they are on the market. Its implementation should also avoid burdens and unnecessary bureaucracy.
On 25 May, the Council and representatives of the European Parliament reached a political agreement about the Medical Devices Regulation. On 15 June, the Council's Permanent Representatives Committee endorsed the agreement reached with the European Parliament. The Commission stated that it also supports the agreement reached between the two co-legislators. The Council’s approval at ministers’ level is planned for September 2016. The directives will apply three years after publication as regards medical devices and five years after publication as regards in vitro diagnostic medical devices.
The view of industry on the new medical devices regulation is in general positive and supportive.
According to MedTech Europe (the alliance of European medical technology industry associations) and the European Trade Association (representing the medical imaging, radiotherapy, health ICT, and electromedical industries (COCIR)), the new legislation should avoid unnecessary red tape and a lot of work will remain after the regulations have been adopted and published. They find the political agreement an important step that brings the process closer to its conclusion and possible adoption.
A central European database will contain all devices, labelled with a unique code, in order to be traceable for surveillance, to assure safety and effectiveness, according to the President of the European Public Health Association Section on Health Technology Assessment. Although the European Consumer Organization (BEUC) is happy with this database, as it will be easier to monitor medical devices once they are on the market, they note that it is a pity that we have to wait a few more years before consumers will truly benefit.
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