The Medical Device Coordination Group issued a new guidance document, available: HERE
The full title is: “Guidance on appropriate surveillance regarding the transitional provisions under Article 120 of the MDR with regard to devices covered by certificates according to the MDD or AIMDD”
MDR, Article 120 covers the ‘Transitional provisions’, including:
MDCG 2022-4 outlines the requirements for Notified Body surveillance audits for these legacy devices. Therefore, it is a worthwhile read for manufacturers with MDD/AIMDD CE Marking certificates, as this directly impacts you during your next audit.
The following aspects of the MDR apply to legacy devices:
The above is true whether the device has a Notified Body CE Marking certificate or is self-certified.
There is a helpful MDCG 2021-25 guidance document that outlines what aspects of the MDR apply to legacy devices. Particularly useful is the table starting page 9. It has an easy to understand ‘YES’ / ‘NO’ format regarding whether certain articles of the MDR apply.
Two main points:
Regarding what to expect during the audit, MDCG 2022-4 recommends that the Notified Body audit “should be a continuation of the previous surveillance activities with a focus on the new provisions”.
Outside of the above items, your MDD/AIMDD quality system should be maintained ‘as is’.
MDCG 2022-4 specifies that provisions outside of the above-mentioned, should not be included the scope of the surveillance audit. For example, the requirement for a Person Responsible for Regulatory Compliance (Art. 15) and UDI (Art. 27) are outside the scope.
Annex in MDCG 2022-4 contains an excel sheet comparing the QMS requirements under the MDD versus MDR.
Per the MDR, this registration should occur in the EUDAMED system. However, EUDAMED has been delayed and is not expected to be fully functional until Q2 2024. Therefore, manufacturers must comply with the registration requirements as outlined under the MDD/AIMDD until EUDAMED is mandatory. It is likely you are already compliant, although it would be good practice to re-verify that you have met the registration obligations under the old Directives.
The Notified Body may perform the audit to the MDR, and may couple MDR audits with the legacy device audit of the Art. 120(3) transition requirements, with proper justification.
There are a lot of CE certificates on the market with an expiry date of 26 May 2024, which is the day the transition period ends. If you were scrambling to recertify to the MDD/AIMDD before the MDR’s date of application (26 May 2021), then so were many other manufacturers. We recommend starting an MDR certification dialog with your Notified Body sooner rather than later. They will be inundated with work the year before the legacy transition period ends.