In Switzerland, the vigilance framework is regulated by the Swiss Medical Devices, and the In Vitro Diagnostic Medical Devices Ordinances (MedDO and IvDO). Post-market vigilance reporting is a fundamental obligation for manufacturers of devices, and healthcare professionals.
As the number of serious incidents reports increases, industry stakeholders have identified areas of concern affecting vigilance activities. On 12 December 2025, Swissmedic and Swiss Medtech have published a joint memorandum, addressing these concerns, and proposing measures to mitigate said challenges.
Key vigilance challenges and agreed solutions: what manufacturers need to know
Years of structured dialogues between the Swiss competent authority and industry representatives highlighted several recurring vigilance challenges:
- Manufacturers face short response timelines
- Authorities raise questions on non-reportable cases
- The management of follow-up requests is unclear
The parties involved aligned on practical measures to streamline vigilance, reduce administrative burden, and support patient safety in a proportionate manner.
- Short response timelines will apply to urgent cases, and when information is readily available. Manufacturers may request extensions.
- For cases deemed non-reportable, manufacturers must carefully assess reportability beforehand, within 15 days of becoming aware of the incident, to avoid delays.
- Swissmedic will minimise repeated questions, but may follow up if new trends arise. Manufacturers must clearly justify non-reportable cases.
How to report incidents in Switzerland: an overview
The measures above implement Switzerland’s broader vigilance reporting framework. Under MedDO and IvDO, manufacturers of devices and other economic operators must report serious incidents occurring in Switzerland and Liechtenstein to Swissmedic.
How to report
Manufacturers must use the Manufacturer Incident Report (MIR) form, complete it in English or a Swiss national language, and send it as XML and PDF file to materiovigilance@swissmedic.ch. The latest version of the form (MIR 7.3.1) becomes mandatory for use as of 1 May 2026.
When to report
Reporting timelines depend on the severity of the incident:
- 2 calendar days for incidents constituting serious public health threat
- 10 calendar days for incidents resulted in death or unexpected person’s health deterioration
- 15 calendar days for all other serious incidents
Additional reporting types
In addition to single incidents, manufacturers may also need to submit:
- Trend Reports, when a significant increase in non-serious incidents, expected undesirable side-effects, or device’s performance erroneous results arise.
- Periodic Summary Reports, to group similar serious incidents that share a known root cause or meet common criteria.
- If a manufacturer conducts a Field Safety Corrective Actions (FSCA) involving devices available on the Swiss or Liechtenstein market, it must notify Swissmedic without delay.
Swissmedic makes available all applicable submission forms and relevant guidance for each reporting type on its dedicated website.
How can Obelis Swiss GmbH help?
For all manufacturers who are not based in Switzerland or Liechtenstein, their appointed Authorised Representative may assume responsibility of incident reporting tasks. Obelis Swiss GmbH, acting as Swiss Authorised Representative, supports manufacturers in fulfilling their vigilance obligations, and in interactions with Swissmedic, helping ensure timely compliance and regulatory continuity on the Swiss market.
Do you have questions on registrations of medical devices and IVDs? Contact us today here.
Giorgia Peotta
Regulatory Intelligence & Innovation
19/01/2026
Reference:
Fedlex. (2020). Medical Devices Ordinance. Retrieved on 19/01/2026.
Fedlex. (2022). In Vitro Diagnostic Medical Devices Ordinance. Retrieved on 19/01/2026.
Swissmedic. (2025). Economic Operators. Retrieved on 19/01/2026 from Economic operators.
Delfosse, D., & Wälti, M. (2025). Memo: Vigilance Reporting in Switzerland. Swiss Medtech. Retrieved on 19/01/2026 from MDR Portal | Swiss Medtech.
Swissmedic (2025). Guidance document: Incident economic operators (MU680_20_009, Version 3.6). Retrieved on 19/01/2026 from Economic operators.
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