EU Council & Parliamentary councils signs off on new med device, IVD regs

June 16, 2016 By Fink Densford Leave a Comment

The Environment, Public Health and Food Safety Committee of the European Parliament and Council’s Committee of Permanent Representatives voted yesterday to endorse new medical device and in vitro diagnostic regulations, according to MedTech Europe.

The approval paves the way for for the adoption of 2 new draft regulations by the end of 2016, though the new rules would not take effect for 3 years in relation to medical devices and 5 years for IVD.

The new regulations cover the design, manufacturing and clinical testing of medical devices and in vitro diagnostics, and will affect all device manufacturing and sales in the E.U., according to the report.

“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. I believe that the new regulations are critical in filling in the gaps of the existing laws and in bringing a more harmonized set of guidelines across the region” MedTech Europe CEO Serge Bernasconi said in prepared remarks.

Consolidated texts from the new regulations are expected to undergo legal review and translations in the coming months.

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