Commission ‘Must Act’ Over Uncertain Virtual Audit Situation As Threat Looms Over MDR Certificates
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.
You may also be interested in...
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.
Notified bodies may temporarily deviate, where fully justified, from the MDR and IVDR rules for notified body audits of manufacturers’ QMS to take place on site. Vital audits can now go ahead.
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.