EUDAMED UDI/Devices User Guide – Release 3.22: What Manufacturers Need to Know
Release 3.22 of the EUDAMED UDI/Devices User Guide provides updated guidance on MDR and IVDR device registration, UDI requirements, EMDN codes and lifecycle management for manufacturers.
European Commission Publishes Results of the Second Survey of Economic Operators: Key Takeaways for Medical Device Manufacturers
The European Commission has published the results of its second survey of Economic Operators, revealing the main challenges manufacturers face under the MDR and IVDR. The findings highlight increased administrative burden, regulatory complexity and supply chain challenges, offering important insights for companies placing devices on the EU market.