Swissmedic PMS
Swissmedic Tightens PMS Compliance Checks: Are You Ready?
📢 Swissmedic’s latest campaign highlights major post-market surveillance (PMS) compliance failures. Is your company prepared?
Swissmedic’s 2025 focus campaign reviewed 30 legacy medical devices from non-Swiss manufacturers, revealing widespread non-compliance in PMS documentation.
⚠ Key compliance gaps:
🔹 67% of assessed devices had PMS non-conformities.
🔹 Safety reports lacked required details on device usage and benefit-risk assessments.
🔹 Swiss Authorized Representatives played a crucial role in PMS oversight but faced challenges in documentation submission.
⏳ What’s next?
Swissmedic will enforce corrective actions and impose stricter measures to ensure PMS compliance. Failure to comply could result in regulatory penalties or market withdrawal.
✅ How can manufacturers and Swiss Authorized Representatives prepare?
🔹Conduct PMS plan audits to align with MedDO & EU MDR requirements.
🔹 Ensure PMS safety reports include full lifecycle data.
🔹 Work closely with a trusted regulatory partner for compliance strategies.
At AF Pharma, we support medical device manufacturers with PMS compliance, Swissmedic audits, and Swiss Authorized Representative services.
📩 Need help navigating Swissmedic’s PMS requirements? Contact us at www.afpharmaservice.com.
💬 How do you see post-market surveillance evolving in Switzerland? Let’s discuss!
Swissmedic
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