LIVE — Last crawled: 2026-05-07 17:57 JST
Vol.1 — May 8, 2026
MSC Portal Regulatory Watch All Entries (42)
Standards, Guidance & Notices
Showing 31–40 of 42
EU
MDCG
MDCG 2021-17
Applied-for scope of designation and notification of a conformity assessment body – Regulation (EU) 2017/745 (MDR)
PUBLISHED NEW SaMD Classification
MDCG 2021-17 — Applied-for scope of designation and notification of a conformity assessment body – Regulation (EU) 2017/745 (MDR) — (July 2021)
Published: 2021-07-01
EU
MDCG
MDCG 2021-10
The status of Appendixes E-I of IMDRF N48 under the EU regulatory framework for medical devices
PUBLISHED NEW SaMD Classification
MDCG 2021-10 — The status of Appendixes E-I of IMDRF N48 under the EU regulatory framework for medical devices — (June 2021)
Published: 2021-06-01
EU
MDCG
MDCG 2021-8
Clinical investigation application/notification documents
PUBLISHED NEW SaMD Classification
MDCG 2021-8 — Clinical investigation application/notification documents — (May 2021)
Published: 2021-05-01
EU
MDCG
MDCG 2021-1 rev.1
Guidance on harmonised administrative practices and alternative technical solutions until EUDAMED is fully functional
PUBLISHED NEW SaMD Classification
MDCG 2021-1 rev.1 — Guidance on harmonised administrative practices and alternative technical solutions until EUDAMED is fully functional — (May 2021)
Published: 2021-05-01
EU
MDCG
MDCG 2019-16 rev.1
Guidance on cybersecurity for medical devices
PUBLISHED NEW Cybersecurity
MDCG 2019-16 rev.1 — Guidance on cybersecurity for medical devices — (July 2020)
Published: 2020-07-01
EU
MDCG
MDCG 2019-8
Guidance document implant card on the application of Article 18 Regulation (EU) 2017/745 on medical devices
PUBLISHED NEW SaMD Classification
MDCG 2019-8 — Guidance document implant card on the application of Article 18 Regulation (EU) 2017/745 on medical devices — (March 2020)
Published: 2020-03-01
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 2019-2
Guidance on application of UDI rules to device-part of products referred to in article 1(8), 1(9) and 1(10) of Regulation 745/2017
PUBLISHED NEW SaMD Classification
MDCG 2019-2 — Guidance on application of UDI rules to device-part of products referred to in article 1(8), 1(9) and 1(10) of Regulation 745/2017 — (February 2019)
Published: 2019-02-01
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
EU
MDCG
MDCG 2024-5 Appendix A
MDCG 2024-5 Appendix A
PUBLISHED NEW SaMD Classification
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