The UK does not know which direction its future will take, with respect to its current leadership and its relationship with the EU, from one hour to the next. But if the EU/UK Brexit Draft Agreement is accepted, there will be some short-term relief for the medtech sector.

The European Commission is optimistic that work on standards for the new EU medtech regulations will begin as soon as May. After previous setbacks, the medtech sector is pinning it hopes on the EU standards bodies, CEN and Cenelec, accepting the Commission’s latest proposal

The medtech sector has reached the point of exasperation over the European Commission’s handling of virtual audits under the MDR and IVDR. Advantages gained by having a delay in the MDR date of application could be all but lost.