At some point, which could be 11pm BST on Friday 12th April, or perhaps a later date if the UK PM obtains her "short" extension, the UK could still fall over the Brexit "cliff edge" and lands with a bump, or perhaps a boom, of a no-deal/ hard Brexit. In anticipation of such an event, what should medical device manufacturers do?
It is less than 2 years before MDR and 4 years before IVDR become fully applicable, and medical devices manufacturers requiring notified body certification for CE marking should assess their regulatory position urgently to avoid the situation of not being able to sell their devices in the EU.
Chapter 2 in the Tale of Brexit, Medical Devices and MDR / IVDR: Suggestions for coping with the regulatory uncertainty
The UK is facing a perfect regulatory storm with the timing for Brexit and the staggered application of the various provisions of MDR and IVDR, with most of the provisions of the latter not being brought onto the UK statute book by the current draft of the EU (Withdrawal) Bill. Without clear guidance from the UK government on this point, it is difficult for medical device companies to know what to do to ensure that they might be able to continue to sell their devices on the market in the UK and the EU27 after Brexit. This post provides some ideas for how to cope with the uncertainty, ensuring you might prepare for the most favourable position in readiness for Brexit (scroll to section 4. at the bottom if you want the advice without the theory).