Brussels, 07/10/2015 (Agence Europe) - On Monday 5 October, the EU Council of Ministers formally adopted its negotiating position at the EPSCO Council meeting in Luxembourg on medical devices and in vitro diagnosis. The member states' permanent representatives to the EU on the Coreper committee had already given their approval on 23 September. The inter-institutional talks with the European Parliament will now start as planned on 13 October under the watchful eye of the European Commission. The member states were able to reach partial agreement on two draft regulations at the Health Council of 19 June under the Latvian Presidency, leaving technical details to be sorted out (see EUROPE 11339). The Luxembourg Presidency got down to work immediately in the summer and managed to iron out all the technical aspects in September, enabling the Council meeting in October to reach broad agreement on both draft regulations.
Ahead of the talks that are about to begin, MedTech Europe, which represents players in the medical devices industry (Eucomed) and the in vitro diagnosis devices industry (EDMA) in Europe, is calling on negotiators to not lose sight of the two objectives set by the legislation, namely ensuring the highest degree of safety for patients while ensuring the development and competiveness of the medical device industry in Europe, because the new legislation will have considerable consequences in the European market.
“We need this regulation, but policy makers must ask themselves: does each new measure see a real increase in patient safety, help rather than hinder needed innovation for patients and avoid unnecessary complexity for SMEs and regulators,” explained the director of MedTech Europe, Serge Bernasconi. The medical devices and in vitro diagnosis industry fears that increased controls of medical devices in the name of patient safety will hold back expansion in this innovative sector. (Original version in French by Isabelle Lamberty)