Unprecedented Number Of EU Medtech Guidance Documents Now Available On New Commission Website
The European Commission’s output of guidance documents over the last few months has been extraordinary, and unprecedented. A new website gives users access to all these documents and shows what has changed.
You may also be interested in...
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.