Labeling Requirements for the EU, UK and Switzerland In-Country Representative
February 21, 2022
Upcoming Deadline to appoint Swiss Authorized Rep for Mid-risk Devices
March 1, 2022The 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”
Overview
MDR, Article 120 covers the ‘Transitional provisions’, including:
- which devices are eligible, referred to as ‘legacy’ devices
- which aspects of the MDR will apply to legacy devices
- how long the transition period lasts
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.
Manufacturer’s MDR Obligations for Legacy Devices
The following aspects of the MDR apply to legacy devices:
- Post-market surveillance
- Vigilance
- Market surveillance
- Registration of economic operators and of 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.
MDR Topics Under Audit Scope
Two main points:
- The above-mentioned aspects of the MDR apply to legacy devices. Therefore, the Notified Body will be auditing to ensure you comply with those relevant MDR sections. This includes Art. 85 – Post-market surveillance report (PMSR), applicable to Class I devices and Art. 86 – Periodic safety update report (PSUR), applicable to Class IIa, IIb and III devices. Manufacturers should update relevant procedures and generate their Post-market Surveillance (PMS) Plans and Post-market Surveillance (PMS) Reports, as well as the PMSR or PSUR, as applicable. This includes ensuring that your risk management and clinical data is considered in the PMS Plan.
- One of the requirements of Article 120(3) is that there “are no significant changes in the design and intended purpose” of the device. Otherwise, the device needs MDR CE Marking. Therefore, the Notified Body will assess that the scope has not changed and that the manufacturer has adjusted its quality system related to significant changes.
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”.
MDR Topics Not Under Audit Scope
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.
Exceptions and Special Circumstances
Registration of economic operators and devices:
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.
You have both MDD/AIMDD and MDR devices:
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.
Final Note
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.
