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5 April 2017 - EU Parliament adopts new medical device and diagnostics regulations

5 April 2017 – The final vote of the European Parliament has endorsed the new Regulation on Medical Devices (MDR) and the new Regulation on In vitro Diagnostic Medical Devices (IVDR). The official timings for transition start 20 days after the new laws are published in the Official Journal. This is expected in early May, which means an official transition starting date around the 1st of June. The Regulations will be fully applicable in three years for medical devices and in five years for in vitro diagnostics medical devices.

The amount of effort needed from manufacturers, notified Body (NB) and European authorized representatives (EARs) to implement these new regulations cannot be underestimated. Essential elements, like N.B. availability to handle the new requirements and the issue of EARs liability for defective devices, should be dealt with outmost urgency. There is a high risks of disruption of needed medical technologies for health care professionals and their patients .

For the medical device sector, a three-year transition period is very tight for the updated clinical evaluation requirements, implementation of the new ‘scrutiny’ process and the availability of N.B.s to handle the enormous flow of new and renewal dossiers that these regulations trigger. It is expected that 50% of the current N.B.s will drop out the medical business while current EAR companies will focus their activities on consulting to avoid the liability issue raised by the new regulations.

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