Standards, Guidance & Notices
Showing 11–15 of 15
EU
MDCG
MDCG
MDCG 2023-4
Medical Device Software (MDSW) – Hardware combinations Guidance on MDSW intended to work in combination with hardware or hardware components
MDCG 2023-4 — Medical Device Software (MDSW) – Hardware combinations Guidance on MDSW intended to work in combination with hardware or hardware components — (October 2023)
Published: 2023-10-01
EU
MDCG
MDCG
Helsinki Procedure
Helsinki Procedure for borderline and classification under MDR & IVDR
Helsinki Procedure — Helsinki Procedure for borderline and classification under MDR & IVDR — (September 2021)
Published: 2021-09-01
EU
MDCG
MDCG
MDCG 2019-16 rev.1
Guidance on cybersecurity for medical devices
MDCG 2019-16 rev.1 — Guidance on cybersecurity for medical devices — (July 2020)
Published: 2020-07-01
EU
MDCG
MDCG
MDCG 2020-1
Guidance on clinical evaluation (MDR) / Performance evaluation (IVDR) of medical device software
MDCG 2020-1 — Guidance on clinical evaluation (MDR) / Performance evaluation (IVDR) of medical device software — (March 2020)
Published: 2020-03-01
EU
MDCG
MDCG
MDCG 2018-5
UDI assignment to medical device software
MDCG 2018-5 — UDI assignment to medical device software — (October 2018)
Published: 2018-10-01