As the long road to the UK’s formal withdrawal from the EU came to an end, this signalled a degree of regulatory certainty at least in the UK until the end of the transition period on 31st December 2020. During this period the UK will remain aligned with EU law, and the current rules on trade and business for the UK and EU will continue to apply. During the run-up to withdrawal, the situation regarding UK-certified medical devices has been the subject of much concern. However, it appears that products with a UK notified body number may continue to be placed on the EU market during the transition period. There is certainly no requirement for an EU-based authorised representative during this time.
Companies can continue to submit information to the MHRA using the existing routes. This includes reporting of serious adverse incidents. MHRA will continue to report into the systems it has access to. They will also continue to provide expert advice during the transition and access for UK-based companies to the EU agencies and authorities will remain.
The UK’s participation in certain decision-making bodies will cease but the decisions of those bodies will be respected in the UK. Preparations are now underway to formulate the positions to be taken by the UK in the forthcoming withdrawal negotiations. The UK industry association, ABHI, is providing input to the relevant government departments.