Commission outlines system improvements achieved thus far and highlights remaining gaps to be addressed in new Regulation
Brussels, 18 June 2014 - Eucomed, the European medical technology industry association, today welcomes the release of a Commission Staff Working Document which outlines progress on the Implementation of the Joint Plan for Immediate Actions under the existing Medical Devices Directives. The Commission’s assessment confirms that much needed improvements to Europe’s notified body system have been successfully implemented and are already yielding tangible results. The Commission also outlines a series of remaining gaps in the system that it believes can only be appropriately addressed in the new Regulation.
The conclusions outlined in the Commission’s staff working document reflect the collective feedback from Eucomed member companies that Europe’s notified body system is now subject to tightened controls with tangible results such as unannounced audits of manufacturers and notified bodies. Eucomed has long championed the need for stronger, more controlled and more specialised notified bodies and welcomes the Commission’s concrete progress to that end. “There is a feeling across the MedTech industry and among the notified bodies that things are already tightening up across the board.” said Eucomed CEO Serge Bernasconi. “The Action Plan very much reflects our recommendation to implement a ‘reinforced control procedure’ rather than turning the system on its head with a complex, costly and overly bureaucratic measure like the ‘scrutiny procedure’ contained in the Commission’s initial proposal and the European Parliament’s first reading agreement.”
Eucomed also welcomes the Commission’s clear delineation in the final pages of their report of the issues that are critical to a strengthened system and must be addressed in the new Regulation, including the obligations of notified bodies, clinical evaluation and vigilance. The European medical device industry also welcomes the Commission’s reference to registries and looks forward to further dialogue on the topic. “Member States, in collaboration with the Commission, and in particular its Joint Research Centre, JRC, and DG SANCO's audit and inspection service, have made astonishing progress towards improving the system,” Mr Bernasconi said, “but perhaps more importantly, in this document they have made clear where there is more work to be done. I am hopeful that the Commission’s emphasis on these points will serve as inspiration to the Council as it continues negotiations towards its position.”
Eucomed is the European medical technology industry association. Its mission is to make modern, innovative and reliable medical technology available to more people. Eucomed represents directly and indirectly 25,000 designers, manufacturers and suppliers of medical technology used in the diagnosis, prevention, treatment and amelioration of disease and disability. Small and medium sized companies make up more than 95% of this sector. The market size is estimated at roughly € 100 billion while the industry reinvests around €4 billion per year back into research and development. The industry employs more than 575,000 highly skilled workers. For more information visit www.eucomed.org.