EU MDR/IVDR 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...
MDCG 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...
EU MDR/IVDR 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...
EU MDR/IVDR 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...
EU MDR/IVDR 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...
