Swissmedic 2026 Focus Campaign on Post-Market Surveillance for Higher-Risk Medical Devices

Swissmedic has announced a 2026 focus campaign targeting post-market surveillance (PMS) requirements for higher-risk medical devices placed on the Swiss market. The campaign will include a random selection of Class IIa, IIb, and III devices, with manufacturers and Swiss Authorized Representatives required to submit PMS documentation for regulatory review.

Scope of the Swissmedic 2026 Focus Campaign

The campaign is part of Swissmedic’s ongoing market surveillance activities under Swiss medical device legislation. It focuses specifically on higher-risk devices already placed on the market.

Devices Included in the Review

Swissmedic will randomly select medical devices from the following risk classes:

• Class IIa  

• Class IIb  

• Class III  

The selection will not be limited to specific technologies, meaning all higher-risk device categories may be subject to review.

Post-Market Surveillance Documentation Review

For selected devices, Swissmedic will request comprehensive post-market surveillance documentation. This may include:

• Post-Market Surveillance (PMS) Plans  

• Periodic Safety Update Reports (PSURs) where applicable  

• Post-market clinical follow-up (PMCF) data  

• Complaint and vigilance records  

• Trend analysis and corrective action documentation  

The documentation will be submitted by either the Swiss manufacturer or the Swiss Authorized Representative.

Regulatory Objective of the Campaign

The focus campaign is designed to verify compliance with Swiss PMS requirements and ensure that manufacturers maintain effective post-market systems. Key objectives include:

• Ensuring continuous monitoring of device safety and performance  

• Verifying proper implementation of PMS systems  

• Checking adequacy of PSUR and PMCF activities  

• Identifying gaps in post-market evidence collection  

This reflects Swissmedic’s commitment to proactive market oversight.

Impact on Manufacturers and Authorized Representatives

The campaign increases regulatory scrutiny of post-market activities for higher-risk devices. Manufacturers should expect:

• Potential requests for detailed PMS documentation  

• Review of PMS system effectiveness  

• Assessment of PSUR completeness and quality  

• Increased focus on traceability of post-market data  

Non-compliance or incomplete documentation may lead to further regulatory action or corrective requirements.

Compliance Expectations

Manufacturers placing Class IIa–III devices on the Swiss market should ensure:

• PMS systems are fully implemented and documented  

• PSURs are up to date and aligned with regulatory requirements  

• PMCF activities are properly planned and executed  

• Vigilance reporting processes are complete and traceable  

• Documentation is readily available for Swissmedic inspection  

Regulatory Context in Switzerland

This campaign forms part of Switzerland’s broader medical device surveillance framework, which emphasizes:

• Continuous post-market oversight  

• Alignment with international PMS expectations  

• Risk-based regulatory supervision  

• Strengthened accountability of manufacturers and representatives  

External Resource

Swissmedic Switzerland Medical Device Registration

External Resource

Swissmedic Official Information (PMS Focus Campaign 2026)

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