EU MDR/IVDR
The Medical Device Coordination Group (MDCG), an advisory body of the European Commission responsible for medical devices regulations, has published a guidance document dedicated to the integration of the UDI within organizations’ quality management systems. The MDCG...
EU MDR/IVDR
The Medical Device Coordination Group (MDCG), an advisory body of the European Commission responsible for medical devices regulations, has published a joint implementation and preparedness plan for Regulation (EU) 2017/746 on in vitro diagnostic medical devices...
EU MDR/IVDR
The Medical Device Coordination Group (MDCG), an advisory body of the European Commission responsible for medical devices regulations, has published a questions-and-answers document dedicated to the European Medical Device Nomenclature (EMDN). It is important to...
EU MDR/IVDR
The Medical Device Coordination Group (MDCG), an advisory body of the European Commission, the EU regulating authority in the sphere of medical devices, has published updated guidance on standardization. Due to its legal nature, the document should neither be treated...
EU MDR/IVDR
The Medical Device Coordination Group (MDCG), an advisory body of the European Commission, has published a guidance document dedicated to the application of transitional provisions for certification of class D in vitro diagnostic medical devices according to the In...
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...
