Is MEDDEV 2.12/1 rev. 8 still valid for Vigilance procedures?
If not, what are the reference documents?
The MEDDEV 2.12/1 rev. 8, January 2013 was in operation under the Directives (Directive 93/42/EEC (MDD), Directive 90/385/EEC (AIMDD)) and Directive 98/79/EC (IVDD)). It is not aligned with the requirements of the Regulations and is considered. obsolete
You shall update your Vigilance Procedures with the following documents:
– 2024-01-15 MDCG 2024-1 Guidance on the vigilance system for CE-marked devices & DSVG 00 Template – January 2024
– 2024-11-01 MDCG 2023-3 Rev. 1 Questions and Answers on vigilance terms and concepts as outlined in the MDR & IVDR Regulations.
And eventually:
– MDCG 2021-1_MDR guidance-administrative-practices_en until EUDAMED is fully
functional
– MDCG_2022-12_ IVDR guidance-administrative practice until EUDAMED is fully functional