Eucomed MedTech Forum 2010: EU team needed to analyse clinical investigations?
This article was originally published in RAJ Devices
Should the European Commission create a structure whereby a high-level team of clinical and technical experts analyses a manufacturer's application for clinical investigation for a given medical device? And should such a procedure replace the current system where a single competent authority reviews the application nationally with the support of an ethics committee?
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.