Updated Registration Guidance for Reusable Class I and Upclassified Medical Devices in the UK

Key Findings:
Swissmedic’s review of post-market surveillance (PMS) documentation for higher-risk medical devices uncovered significant non-conformities in 20 out of 30 cases, accounting for 13.5% of examined aspects. A total of 85 non-conformities were identified across PMS plans, safety reports, and PMS systems.

Main Compliance Issues:

Missing or Non-Compliant PMS Plans: 11 products lacked an adequate PMS plan.
Deficient Safety Reports: In 8 cases, the safety report did not align with the PMS plan.
Timely Submission: Swiss authorized representatives provided required documents on time in 25 out of 28 cases.
Regulatory Actions:

Swissmedic requires manufacturers to strengthen PMS processes and ensure compliance with the Medical Devices Ordinance (MepV).
Corrective measures are being implemented to address gaps, with further regulatory actions possible if deficiencies persist.
This review highlights the critical importance of robust PMS documentation in ensuring the safety and effectiveness of medical devices in Switzerland.

Region: European Union

Source: https://www.swissmedic.ch/dam/swissmedic/de/dokumente/medizinprodukte/infos/ueberpruefung-dokumentation-ueberwachung-nach-inverkehrbringen-smc.pdf.download.pdf/DE_Schwerpunktaktion_PSUR-final.pdf