Industry Perspective on the Implementation Status of the MDR/IVDR
Posts published in “In Vitro Diagnostic Medical Device Regulation IVDR”
European Commission expert panels on medical devices and in vitro diagnostic devices
Factsheet for healthcare professionals and health institutions
Update from the EU Council – Public session (health) – Friday, 14 June 2019 10:25 CET
UK NB Will Not Apply for EU MDR/IVDR
The next meeting of the MDCG is schedule for 20 June 2019. Some guidance are up for endorsement: Vigilance: Manufacturer Periodic Safety Report (MPSR) form…
Commission Implementing Decision (EU) 2019/939 of 6 June 2019 designating issuing entities designated to operate a system for the assignment of Unique Device Identifiers (UDIs)…
MDCG 2019-6 Questions and answers: Requirements relating to notified bodies
Eudamed Data Exchange Guidelines
Eudamed Data exchange services and entity models introductions