Archives: Downloads
MDCG 2024-12 CAPA plan assessment including 2 templates
Call to medical device manufacturers: implement an effective PMS system
MDCG 2024-11 Guidance on qualification of in vitro diagnostic medical devices
IVDR
MDCG 2021-4 Q&A on Class D IVD during transition period rev. 1
IVDR
Notified Body
Code of Conduct
Notified Bodies
Notified Body
MDR – national language requirements for manufacturers – Rev.2
IVDR – national language requirements for manufacturers – Rev.2
IMDRF/MC/N84 FINAL:2024 IMDRF Document Implementation Report
SaMD
UDI
RPS
GRRP
PMD
AET
MDCE
Cyber
IVD Classification
AI
Notified Body confirmation letter under Regulation (EU) 2024/1860
IVDR