Theme Vigilance
Target Audience Competent authorities, economic operators, and other interested parties
Products concerned MD
Regulatory reference MDR (EU) 2017/745
Documents mentioned MEDDEV 2.12/1 rev.8
Regulation (EU) No 1025/2012
EN ISO 15223-1:2021
Manufacturer Incident Report (MIR)
EN ISO 13485:2016
EN 62366-1:2015
EN ISO 14155:2020
EN ISO 14971:2019
EN 62366-1:2015/AMD1
Regulation (EEC, EURATOM) NO 1182/71
MDCG 2021-1
Commission implementing regulation (EU) 2021/2078
MDCG 2021-27

This MDCG guide provides clarification of terms and concepts on the implementation of the vigilance process according to Regulation (EU) 2017/745 and thus replaces MEDDEV 2.12/1 rev.8 which was applicable under Directives 93/42/EEC and 90/385/EEC.