Will MDR Delays Create Roadblocks For Companion Diagnostics Regulation?
Companion diagnostics are needed increasingly by pharma companies to justify the safety and effectiveness of their products. With specific first-time EU regulation of these products within sight – and urgently needed – is there a risk of delays to these products being able to demonstrate compliance?
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With less than three months to go until the full application of the EU’s Medical Device Regulation, industry is trying to put its foot on the accelerator, but is finding the brakes are on.
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.