The Board of MedTech Europe has issuing the following recommendation to IMSTA/its members:
If you have any business interaction with the UK, consider this as a critical and urgent situation requesting all your attention. Anticipate business continuity plans including a “hard Brexit” scenario that should include no recognition of your UK CE marked products in the EU27 after the end of the transition period. This includes not only products originating in the UK but products from other countries who used UK Notified Bodies to gain CE marking, e.g. BSI (Italics added by IMSTA).
These plans need to take into consideration the possible delays in product re-certification by Notified Bodies due to the transition into the new Medical Device Regulation (2020) and IVD Regulation (2022).
The dynamic of the negotiations will evolve as we get closer to the end of the transition period and to a possible “cliff”. Rest assured that MedTech Europe will continue to put all their effort in advocating their proposition up to and even after the end of the transition period. We will keep you informed on the evolution of the situation, which is fully monitored by the Board of MedTech Europe and its dedicated Brexit Task Force.