Swissmedic Launches 2026 PMS Focus Campaign for Higher-Risk Medical Devices

Swissmedic has issued a formal information letter announcing that it will conduct a focus campaign in 2026 reviewing post-market surveillance (PMS) documentation for higher-risk medical devices on the Swiss market. 

Swissmedic’s Division Medical Device Surveillance (MDS) confirmed it will conduct a focused review of PMS documentation for Class IIa, IIb, and III medical devices placed on the Swiss market. A random selection of devices will be identified, and the Swiss manufacturer or Swiss Authorized Representative on record will be contacted and asked to submit relevant documentation for review. 

Swissmedic will specifically assess whether manufacturers have: 

• A compliant post-market surveillance system in place (Art. 56 MedDO) 
• A documented post-market surveillance plan (Art. 58 MedDO) 
• Up-to-date periodic safety reports, PMSR or SSCP as applicable, based on that plan (Art. 60–61 MedDO) 

This campaign follows a similar review conducted in 2024, which found that full compliance with PMS obligations remains a challenge for many manufacturers. The latest Swissmedic report is available here, and a recap of the key outcomes from that campaign is detailed on our website here. 

Swissmedic has made clear that PMS obligations are non-negotiable and that further inspections may occur at any time, independent of any focus campaign. 

What this Means for Manufacturers 

No proactive response to Swissmedic is required at this stage. If one of your devices is selected as part of the sample, you will be notified directly by Swissmedic by separate letter. 

Regardless, manufacturers should treat this announcement as a prompt to verify that their PMS documentation is current, complete, and audit-ready; particularly for higher-risk device portfolios. The three documentation pillars Swissmedic is scrutinizing (PMS system, PMS plan, and periodic safety reports) are ongoing obligations under Swiss MedDO, not one-time exercises. 

How MedEnvoy Can Support  

As a Swiss Authorized Representative (CH-REP), MedEnvoy acts as the formal point of contact with Swissmedic on behalf of foreign medical device manufacturers placing products on the Swiss market. This includes receiving and coordinating responses to regulatory correspondence, such as requests arising from focus campaigns like this one. 

If your PMS documentation is not yet in order, or if you do not currently have a CH-REP in place, now is a good time to act. 

Contact us to learn more about MedEnvoy’s Swiss Authorized Representative services and how we can support your compliance obligations.