5th IVDR Notified Body Appointed Amidst Signs Of Pressure And A Need For Swift Action
TÜV Rheinland has been designated as a notified body under the IVD Regulation. Its appointment is a reminder of how many more notified bodies are needed if the IVDR is to be implemented effectively and on time.
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If the tools are not in place by the end of 2020 to allow diagnostics companies to comply with the EU IVDR, the 2022 compliance deadline should be delayed, say EU notified bodies.
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.