BioStock’s article series on MDR and IVDR: Notified Bodies – potential bottleneck
With the introduction of MDR and IVDR, the regulatory landscape in the EU is undergoing tremendous change. The new regulations are not only causing challenges for manufacturers of medical devices, but also the Notified Bodies (NBs) that issue CE certificates for the medical devices. There is an insufficient number of designated NBs under the new regulations which creates a bottleneck in the transition to the new regulations.
Read the full article at biostock.se:
This is a press release from BioStock - Connecting Innovation & Capital. https://www.biostock.se