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...
Cries for the EU to pay more attention to IVDs are growing louder by the day. It is feared the EU IVD sector is heading for a crisis and safe products will have to be pulled from the market.
Despite COVID-19 distancing measures and fears that new notified body appointments would grind to a halt, there is now a new notified body for the EU Medical Device Regulation.
Many medtech companies are ready to demonstrate compliance with the EU MDR, but COVID-19 notified body auditing restrictions have brought their plans to a halt. The EU is trying to break the impasse.