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.
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There are very few regulatory hurdles to placing a COVID-19 test on the EU market under the IVD Directive. This situation, however, is changing under the IVD Regulation. The European Commission explains what manufacturers need to weigh up when deciding their regulatory pathway.
When Will A Notified Body Conduct An MDR/IVDR Virtual Audit And How? BSI Netherlands Gives Its Views
When it comes to notified bodies deciding whether to undertake virtual audits or not in the context of the new EU medtech regulations, there are many elements that need considering and many different potential responses and cost implications. In this interview, BSI Netherlands explains its approach.