What Has Swissmedic Announced?
Mit dem diesjährigen Schreiben informiert Swissmedic informed all Swiss Authorised Representative (CH-REP) about a new focus campaign. Its goal is to review the compliance obligations related to Post-Market Surveillance (PMS). A similar campaign already took place in 2024 and revealed that full compliance with these obligations is a challenge for many manufacturers.
Three Obligations in Focus
Under the Medical Devices Ordinance (MedDO), manufacturers must:
- Establish a PMS system (Art. 56 MedDO): a system for systematically collecting data on how their products are used.
- Maintain a PMS plan (Art. 58 MedDO): documented, traceable planning of their surveillance activities.
- Prepare safety reports (Art. 60–61 MedDO): periodically documenting the results of their analyses in a Periodic Safety Update Report (PSUR).
Who Is Affected?
All Swiss manufacturers registered with Swissmedic are affected. If you distribute products made by foreign manufacturers in Switzerland, we can act as your Swiss Authorised Representative (CH-REP) and take on the associated formal and safety-related obligations (Art. 51 Para. 2 MedDO). Responsibility for complete PMS documentation therefore always rests with a clearly designated party in Switzerland.
How the Review Works
Swissmedic will select a sample of products placed on the Swiss market. For these products, the authority will request PMS documentation directly from the Swiss manufacturer or the CH-REP and review the documents submitted.
You don't need to respond to the information letter itself. Only if one of your products is actually selected for the sample will you receive a separate, specific letter from Swissmedic.
What You Should Do Now
Even without a specific request, it's worth reviewing your own documentation. Check:
- Is your PMS system active? Are you continuously collecting data on complaints, incidents and user experience?
- Is your PMS plan up to date? Does it reflect your actual products and market activities?
- Is your PSUR on schedule? Have you prepared it at regular intervals appropriate to the risk?
- Is your CH-REP involved? For products from foreign manufacturers, communication between manufacturer and authorised representative must be seamless.
Swissmedic has already published the results of the 2024 focus campaign, a good starting point for spotting typical gaps in your own documentation.
We Support You as Your CH-REP
Audit-ready PMS documentation doesn't happen overnight. Together with our partners at Albo-Healthcare GmbH we support you in building and maintaining your PMS system, your PMS plan and your PSURs and, if needed, we take on the role of your Swiss authorised representative (CH-REP).
Want to know how audit-ready your PMS documentation is right now? Get in touch: Together, we'll bring your documentation up to date.
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