Post-Market Surveillance: A Swiss perspective on critical compliance gaps
Written by: Manuel Mateos CEO and Regulatory Affairs Director, CMC Medical Devices & Drugs S.L.
We’ve previously highlighted how important post-market surveillance (PMS) is, not just as a regulatory requirement, but as an essential tool for safeguarding patient safety and monitoring device performance throughout its entire lifecycle.
Today, we’re revisiting the topic with a focus on Switzerland, where Swissmedic recently released the findings of a targeted review on PMS documentation for higher-risk legacy medical devices.
The review aimed to assess whether manufacturers are meeting the Medical Devices Ordinance (MedDO) requirements, which closely align with several provisions of the EU MDR (Regulation 2017/745).
Swissmedic evaluated a sample of 30 devices classified as Class IIa or higher, selected based on vigilance data. The results were striking: 20 out of 30 showed non-compliance with PMS obligations. This indicates that many manufacturers are still struggling to implement effective and structured post-market surveillance processes.
Among the most frequently observed issues were missing or insufficient PMS plans, safety reports that were not aligned with the planned surveillance strategy, and overall weak or poorly defined PMS systems. In several cases, Swissmedic noted the absence of key data such as sales volumes, user population details, and information related to CAPAs (Corrective and Preventive Actions) or PMCF (Post-Market Clinical Follow-up) activities.
Another important aspect to highlight is the role of the Swiss Authorised Representative (CH-REP). Of the 30 devices reviewed, 28 were produced by non-Swiss manufacturers, which meant the CH-REP acted as the official point of contact with Swissmedic. This once again underlines how essential it is to have a trusted and competent representative managing regulatory responsibilities on behalf of the manufacturer.
The takeaway
Swissmedic’s findings send a clear and timely reminder to all stakeholders: post-market surveillance is not a one-time task to be filed and forgotten. It’s an ongoing responsibility that plays a central role in protecting patient safety and ensuring the continued availability of medical devices on the Swiss market.
For manufacturers, especially those based outside of Switzerland, these results highlight the importance of having a well-structured and fully documented PMS process in place. Just as crucial is the role of the Swiss Authorised Representative (CH-REP), who serves as the formal link with Swissmedic and must be ready to respond promptly and accurately to any request for documentation.
At CMC Consulting, we support you not only in drafting and maintaining compliant PMS plans and safety reports, but also by acting as your trusted CH-REP, ensuring full regulatory alignment and ongoing market access in Switzerland.
