With the position papers MDCG 2022-4 and MDCG 2022-15, Notified Bodies are requested to identify relevant certificates (under Directive 93/42/EEC and 98/79/EC) which are subject to surveillance according to Article 120 (3) of the MDR or Article 110 (3) of the IVDR. The requirement for adequate surveillance of existing legacy devices1/2 by Notified Bodies is sharpened and should be reflected in the audit. This means that the following aspects will become a focus of the audit:
- Transition strategy to MDR / IVDR
- Assessment of (non-) significant changes according to MDCG 2020-3 or MDCG 2022-6
- Adjustments of the requirements according to Article 120 (3) of the MDR or Article 110 (3) of the IVDR in the QMS (including post-market surveillance (Annex III of the MDR / IVDR), market surveillance, vigilance and registration of economic operators and devices)
- Assess whether all appropriate processes related to post-market surveillance, including risk management and performance data, are included in the post-market surveillance plan
For manufacturers, in addition to maintaining the QM system, all requirements must be implemented or mapped.
1Products placed on the market under Article 120(3) of the MDR after the date of application of the MDR (26 May 2021) and until the end of the transitional period on 26 May 2024, provided that certain conditions are met.
2Products placed on the market under Article 110(3) of the IVDR after the date of application of the IVDR (26 May 2022) and until the end of the respective transitional period referred to in the second or third subparagraph of Article 110(3), provided that certain conditions are met.