EU Regulatory Roundup, December 2020: UK Break With EU Tops News Amidst MDR Preparations Latest
Four out of 10 of Medtech Insight's top EU stories were dominated by news related to the implications for medtech of the UK’s final break from the EU on 31 December. But no one should ignore the pressure that implementation of the new EU medtech regulations is causing.
You may also be interested in...
Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Sixty-seven guidance documents have been posted on the tracker since its last update.
The UK responsible person is the UK equivalent of the Authorized Representative in the EU. MedTech Europe’s Jesús Rueda gives an update on the early experiences of medtech manufacturers seeking to comply with the UK’s new standalone regulations.
The European Commission has reluctantly allowed virtual audits in the context of new MDR and IVDR. The EU notified body association is helping the collective effort to meet its strict requirements.