MSC Regulatory Watch — Medical Device Software Regulatory Knowledge Database

MSC Regulatory Watch

Medical Device Software — Regulatory & Standards Knowledge Base

LIVE — Last crawled: 2026-08-13 17:29 JST

Vol.1 — August 14, 2026

MSC Portal ›Regulatory Watch› All Entries (2)

Standards, Guidance & Notices

Showing 1–2 of 2

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CEN/
CENELEC

EN ISO 14971:2019

Medical devices - Application of risk management to medical devices (ISO 14971:2019)

PUBLISHED Risk Management

Regulation: MDR (EU) 2017/745 | Legislation: 2017/745 - Medical Devices | ESO: CEN | Amendments/Corrigenda: EN ISO 14971:2019/A11:2021 | Publication Decision: 2022/757 | Publication OJ: OJ L 138 | Start of legal effect: 17.05.2022

Published: 2022-05-17

CEN/
CENELEC

EN ISO 13485:2016

Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)

PUBLISHED Quality Management

Regulation: MDR (EU) 2017/745 | Legislation: 2017/745 - Medical Devices | ESO: CEN | Amendments/Corrigenda: EN ISO 13485:2016/AC:2018, EN ISO 13485:2016/A11:2021 | Publication Decision: 2022/6 | Publication OJ: OJ L 1 | Start of legal effect: 05.01.2022

Published: 2022-01-05