Standards, Guidance & Notices
Showing 91–100 of 124
EU
MDCG
MDCG
MDCG 2021-18
Applied-for scope of designation and notification of a conformity assessment body – Regulation (EU) 2017/746 (IVDR)
MDCG 2021-18 — Applied-for scope of designation and notification of a conformity assessment body – Regulation (EU) 2017/746 (IVDR) — (July 2021)
Published: 2021-07-01
EU
MDCG
MDCG
MDCG 2021-17
Applied-for scope of designation and notification of a conformity assessment body – Regulation (EU) 2017/745 (MDR)
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
MDCG 2021-10
The status of Appendixes E-I of IMDRF N48 under the EU regulatory framework for medical devices
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
JFMDA
Notice
Notice
jaame_20210510_非邦文試験成績書受入
邦文以外で作成された試験成績書等の受入れについて
Published: 2021-05-10
EU
MDCG
MDCG
MDCG 2021-8
Clinical investigation application/notification documents
MDCG 2021-8 — Clinical investigation application/notification documents — (May 2021)
Published: 2021-05-01
EU
MDCG
MDCG
MDCG 2021-1 rev.1
Guidance on harmonised administrative practices and alternative technical solutions until EUDAMED is fully functional
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
JFMDA
Notice
Notice
jaame-well-known-matters-ikw
PMDAの「IKWサイト」及び添付文書の届出・掲載方法について
Published: 2021-02-13
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
IMDRF
IMDRF/CYBER WG/N60
Principles and Practices for Medical Device Cybersecurity
Published: 2020-04-20
EU
MDCG
MDCG
MDCG 2019-8
Guidance document implant card on the application of Article 18 Regulation (EU) 2017/745 on medical devices
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
