Changes in the guidance on MDR appropriate surveillance – MDCG 2022-4 Rev. 2
Are you the manufacturer who is using the transitional provisions? This guidance is for you. According to Article 120(3e) of the MDR, the notified body that issued your MDD or AIMDD certificate is still responsible for monitoring your devices to make sure they meet the necessary requirements. This means that their surveillance activities will continue as they did before under the previous Directives. The revised guidance regarding the transitional provisions under Article 120 of the MDR concerning devices covered by certificates according to the MDD or the AIMDD is very useful for manufacturers of legacy devices, notified bodies involved in transitional provisions and competent authorities.
According to Article 120(3e) of the MDR, the notified body that issued your MDD or AIMDD certificate is still responsible for monitoring your devices to make sure they meet the necessary requirements. This means that their surveillance activities will continue as they did before under the previous Directives. The revised guidance regarding the transitional provisions under Article 120 of the MDR concerning devices covered by certificates according to the MDD or the AIMDD is very useful for manufacturers of legacy devices, notified bodies involved in transitional provisions and competent authorities.
What are the key points of the MDR appropriate surveillance according to MDCG?
- Manufacturers must have a quality management system that complies with the MDR by 26 May 2024.
- Notified bodies will review evidence in the technical documentation, focusing on the new MDR provisions.
- Manufacturers should make PSURs (outside the EUDAMED), PMS plans, and any PMS reports available to their notified bodies during audits.
- The outcome of the surveillance activities should be documented and provided to the manufacturer.
Finally, the EC proposed very useful checklist on comparison of the “full” quality management system requirements between the Medical Device Directive (MDD) and the medical device Regulation (MDR) using MDR Art. 10 (9) as “backbone”.
See more: