Brexit Delay Gives EU27 Yet More Time To Grow Number Of EU-Compliant Devices
Has the European Commission done enough to allow UK-certified medical devices to continue on the EU27 market in the event of the UK dropping out of the EU without a deal – a possibility that remains very real?
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April 2019 was seemingly a bumper month in terms of the amount of progress toward implementation of the EU Medical Device and IVD Regulations. There is now, finally, a sense that the sector is moving towards implementation of the MDR. But with so much left until so late, will enough progress be achieved in the time left?
While the details of UK's Brexit deal are not finalized, those paralyzed in disbelief at the enormity of the fallout will have to act. The European Commission spells out the upheaval necessary for medtech to realign into the EU-27.
Where are the biggest challenges for notified bodies and manufacturers now there is some experience with the MDR, and can the sector manage the new regulatory requirements successfully?