Archives: Downloads
IMDRF/AIML WG/N88 FINAL: 2025 Good machine learning practice for medical device development: Guiding principles
IMDRF/SaMD WG/N81 FINAL: 2025 Characterization Considerations for Medical Device Software and Software Specific Risk
2021-12 FAQ on the European Medical Device Nomenclature (EMDN) – Rev.1
MDR
IVDR
MDCG 2024-2 Procedures for the updates of the EMDN – Rev.1
EU 2017/745 Medical Device Regulation (2025-01-10)
MDR
Regulation 2020-561 (2020-04-24)
Corrigendum I (2019-05-03)
Corrigendum II (2019-12-27)
2023/607
2024/1860
Consolidated
MDCG 2021-15 Application form NB under MDR + Annex
(EU) 2017/745
MDCG 2021-16 Application form NB under IVDR + Annex
(EU) 2017/746
MDCG 2024-8 Preliminary assessment review (PAR) form template (IVDR) – Rev.1 + Annex
NB
Notified Body
MDCG 2024-7 Preliminary assessment review (PAR) form template (MDR) – Rev.1 + Annex
NB
Notified Body