The Medical Device Coordination Group has published MDCG 2022-4 Rev 2. The guidance document provides clarity on the activities that notified bodies must perform as part of the "appropriate surveillance" required under Article 120(3e) of the Medical Device Regulation (MDR) for legacy devices covered by certificates issued under the previous Directives (MDD/AIMDD). The key topics and takeaways of the revised guidance are:
Scope of Appropriate Surveillance
- Appropriate surveillance only applies to legacy devices covered by valid certificates issued under the MDD or AIMDD.
- It does not apply to devices that did not require notified body involvement under the Directives but do under the MDR.
Manufacturer's Obligations
- By 26 May 2024, manufacturers must have a quality management system (QMS) in place that complies with the MDR requirements.
- MDR requirements for post-market surveillance, vigilance, registration, etc. apply to legacy devices instead of the corresponding Directive requirements.
- Manufacturers must submit Periodic Safety Update Reports (PSURs) as per Article 86 MDR.
Notified Body Activities
- Notified bodies must verify the scope of devices covered by MDD/AIMDD certificates and any changes.
- They must ensure contractual arrangements are in place to maintain rights and duties for appropriate surveillance.
- Review of the manufacturer's QMS documentation is required, including transition plans, change management, and alignment with new MDR requirements.
- Specific focus on verifying implementation of new MDR post-market surveillance processes and PSUR requirements.
The key conclusion is that notified bodies must conduct rigorous surveillance activities to ensure legacy devices meet all applicable MDR requirements during the transition period, with particular emphasis on the manufacturer's QMS and post-market surveillance processes.
Get Expert Guidance on the Latest Regulations
Need help navigating the new guidance document? Contact our experienced medical device consultants today to ensure your products meet all regulatory requirements seamlessly.