Swissmedic: Focus Campaign on Post-Market Surveillance of Medical Devices
Swissmedic will conduct a new focus campaign to assess compliance with post-market surveillance (PMS) requirements for higher-risk medical devices.
A previous campaign in 2024 revealed that many manufacturers face challenges in fully meeting these obligations, particularly regarding the establishment of PMS systems, the definition of surveillance plans, and the regular documentation of results in safety reports.
Swissmedic emphasises the key role of manufacturers and authorised representatives in ensuring device safety and will again review PMS documentation as part of the upcoming campaign.
Source:
Swissmedic: Focus campaigns
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