| 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.