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PRESS RELEASE

Brussels, June 15, 2016 – The medical technology industry welcomes the vote on the consolidated medical device and in vitro diagnostics regulation texts by representatives of the Council and the Parliament today.

The Environment, Public Health and Food Safety (ENVI) Committee of the European Parliament and Council’s Committee of Permanent Representatives (COREPER) voted to endorse the trilogue agreement this afternoon. The texts can be downloaded and viewed on the European Parliament website.
MedTech Europe, the alliance of the medical device association Eucomed and the in vitro diagnostics association EDMA, continue to recognise the importance of these regulations towards the sector and the healthcare continuum at large.

“Medical technologies save lives, improve health and contribute to sustainable healthcare. And many of the proposed updates in the regulations are welcomed by our industry as they will enhance patient safety and facilitate access to new technology” says Serge Bernasconi, CEO of MedTech Europe.“I believe that the new regulations are critical in filling in the gaps of the existing laws and in bringing a more harmonised set of guidelines across the region”, he adds.

EDMA and Eucomed have already begun working on an in-depth analysis of the regulations to assess the overall impact towards the industry…

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