LIVE — Last crawled: 2026-06-24 17:27 JST
Vol.1 — June 24, 2026
MSC Portal Regulatory Watch All Entries (22)
Standards, Guidance & Notices
Showing 21–22 of 22
EU
MDCG
MDCG 2020-1
Guidance on clinical evaluation (MDR) / Performance evaluation (IVDR) of medical device software
PUBLISHED NEW AI / Machine Learning
MDCG 2020-1 — Guidance on clinical evaluation (MDR) / Performance evaluation (IVDR) of medical device software — (March 2020)
Published: 2020-03-01
EU
MDCG
MDCG 2018-5
UDI assignment to medical device software
PUBLISHED NEW AI / Machine Learning
MDCG 2018-5 — UDI assignment to medical device software — (October 2018)
Published: 2018-10-01
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