MDCG 2022-21: Guidance on Periodic Safety Update Reports (PSURs)
20 December 2022
Switzerland: 2022 Recap & 2023 Look Forward
4 January 2023MDCG 2022-4, originally published in February 2022, has been updated this month. The revised guidance can be found: HERE
Background on MDCG 2022-4
It was published to outline the requirements for Notified Body surveillance audits for MDD/AIMDD legacy devices during the MDR transition period, after the MDR’s date of application on 26 May 2021.
Our overview of the original publication in February 2022 is available: HERE
Overview of Changes
It was updated to:
- Align with MDCG 2022-15, which is the equivalent document for IVDR transition surveillance audits
- Reflect the views of MDG 2022-14, which is the MDCG’s Position Paper on how to increase both Notified Body capacity and manufacturers’ readiness to be audited
Changes include deletions and wording changes to ease the surveillance review process.
Examples of Changes
Original text:
“Considering the overall intention of Article 120(3) MDR that not all MDR provisions will already apply to ‘legacy devices’, the audit activities to be performed by notified bodies should be a continuation of the previous surveillance activities with a focus on the new provisions.”
New text:
“Considering the overall intention of Article 120(3) MDR that certain MDR provisions already apply to ‘legacy devices’, the audit activities to be performed by notified bodies should focus on those new provisions. In that context notified bodies should combine surveillance activities under the MDD/AIMDD and the MDR in a meaningful way (see section 5).”
Original text:
“In case of MDD devices falling under classes IIa and IIb, notified bodies are requested to continue the technical documentation assessments on a sampling basis according to the existing sampling plan (see NBOG BPG 2009-413). Generally, this activity needs to be continued as planned but the plan may be adjusted depending on the outcome of the documentation review (section 4.3)”
New text:
“In accordance with MDCG position paper 2022-14 (action n.3) in case of MDD devices falling under classes IIa and IIb, notified bodies should discontinue the technical documentation assessments on a sampling basis according to existing sampling plans under the MDD in line with NBOG BPG 2009-4 15 and focus on technical documentation assessments according to the MDR instead. However, deficiencies identified in previous audits need to be followed up.”
Deletion of the following text:
“Notified body’s procedures should appropriately describe the different scenarios applied and how
audit programmes should be established for individual manufacturers,audit plans should be drawn up and adapted for individual audits (including reference to scope, objective and duration of the audits),the comparison table reported in the Annex to this guidance document has been considered to define notified body’s activities relating to appropriate surveillance,in case similarities are claimed, these similarities, including scope, manufacturing sites, processes, supplier/subcontractors, etc., have been demonstrated.”
Takeaway
The MDCG – and EU Council – are working to ease the transition process for both Notified Bodies and manufacturers. There are too few Notified Bodies, not enough capacity, MDD/AIMDD certificates are expiring with no MDR Certificate in sight, and extreme concern about the lack of medical devices available on the European market.
The above is one of the steps taken, to ease the process until the MDR compliance date is formally postponed.
For more information on the proposed MDR delay, please read: EU Council Supports Postponement of the May 2024 MDR Deadline
