The European Commission (EC), the EU body responsible for medical device regulations, has published a Q&A document dedicated to in vitro diagnostic medical device conformity assessment and performance in the context of COVID-19. The guidance is intended to provide...
The Medical Device Coordination Group (MDCG), an advisory body of the European Commission comprised of the representatives of all Member States, has published a guidance document dedicated to harmonized administrative practices and alternative technical solutions...
The European Commission (EC), the EU regulating authority in the sphere of medical devices, has published a document describing the regulatory requirements under the MDR EUDAMED framework. Regulatory Background The new guidance published by the European Commission...
The Notified Body Operations Group (NBOG), an organization established by the European Commission to improve the performance of notified bodies earlier in 2000, has published a best practice guide dedicated to the designation and notification of conformity assessment...
The Notified Body Operations Group (NBOG), an organization established by the European Commission to improve the performance of notified bodies earlier in 2000, has published a best practice guide dedicated to the designation and notification of conformity assessment...