MEDDEV 2.12-1 rev 8 (Vigilance guidelines) still applicable with the MDR implementation?

[RA Expert]

Hello Everyone,
With the implementation of the new Medical Device Regulation, do you know if the MEDDEV 2.12-1 rev 8 (GUIDELINES ON A MEDICAL DEVICES VIGILANCE SYSTEM) is still applicable?
Thanks in advance for your help!

 

[florijanl]

ttps://johner-institute.com/articles/regulatory-affairs/and-more/post-market-surveillance/

According to this article it can still be used (add h infront of the link)

 

[Aliken]

Hello Everyone,

Please note that according to MDCG 2023-3 (see footnote 1), released last month (February 2023), MEDDEV 2/12-1 rev. 8, January 2013 (operative under the MDD), and AIMDD) is not applicable under the MDR (and IVDR).

Regards,
Daniel

 

[Orca1]

Hello Everyone,
With the implementation of the new Medical Device Regulation, do you know if the MEDDEV 2.12-1 rev 8 (GUIDELINES ON A MEDICAL DEVICES VIGILANCE SYSTEM) is still applicable?
Thanks in advance for your help!

With the implementation of the new MDR and IVDR, the MEDDEV 2.12-1 rev 8 guidelines on medical devices vigilance system are no longer directly applicable. Instead, the MDR and IVDR have introduced new requirements for post-market surveillance, market surveillance, vigilance, and registration of economic operators and devices.

For legacy devices, which are devices placed on the market after the MDR or IVDR dates of application and until 26 May 2024, or until the relevant certificate becomes void, the new requirements apply in place of the corresponding requirements in the Directives (MDCG 2021-25, MDCG 2022-8). This includes the reporting and analysis of serious incidents and field safety corrective actions occurring after the date of application of the MDR or IVDR (MDCG 2022-8, Page 7, Paragraph 2).

However, the quality management system approved under the Directives needs to be maintained for legacy devices (MDCG 2022-4, Page 3, Paragraph 3). Notified bodies responsible for the appropriate surveillance of legacy devices should take into account the new requirements that apply to manufacturers resulting from the transitional provisions (MDCG 2022-8, Page 5, Paragraph 4).