February’s Reg Top Hits: Concerns Over Notified Body Performance Under Spotlight Again
This article was originally published in Clinica
Articles on notified bodies and the ongoing trilogue discussions attracted the most attention from Clinica subscribers during the month of February.
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.