Vigilance relating to medical devices

According to the Therapeutic Products Act (TPA, SR 812.21), professional users are required to notify Swissmedic of serious incidents that occur in connection with therapeutic products (Art. 59 para. 3 TPA). The obligation to report serious incidents connected with medical devices is regulated by the Medical Devices Ordinance (MedDO, SR 812.213) and the Ordinance on In Vitro Diagnostic Medical Devices (IvDO, SR 812.219).

According to Art. 66 para. 4 MedDO and Art. 59 para. 4 IvDO, any professional person who, in the course of their work, becomes aware of a serious incident when using a medical device must report this to the supplier and to Swissmedic.

The corresponding reports must be submitted within 2, 10 or 15 days, depending on the risk involved (Art. 87 of Regulation (EU) 2017/745 on medical devices [EU-MDR] and Art. 82 of Regulation (EU) 2017/746 on in vitro diagnostic medical devices [EU-IVDR]).

The terms "incident" and "serious incident" are defined in Art. 2, numbers 64 and 65 EU-MDR and Art. 2 numbers 67 and 68 EU-IVDR.

In the context of medical devices, vigilance refers to the system for monitoring the risks associated with the use of medical devices. As users of these devices, hospitals are often the first to become aware of any problems or risks during incidents. Accordingly, they must:

  • establish an internal system for reporting serious incidents connected with medical devices as part of an established quality management system (Art. 67 para. 1 MedDO and Art. 60 para. 1 IvDO);
  • designate an appropriate person with medical or technical training (vigilance contact person) with responsibility for ensuring compliance with the obligation to report to Swissmedic (Art. 67 para. 2 MedDO and Art. 60 para. 2 IvDO);
  • keep the records and all documents produced in connection with the quality management system for vigilance for at least 15 years (Art. 67 para. 3 MedDO and Art. 60 para. 3 IvDO);
  • store and keep, preferably by electronic means, the unique device identifier (UDI) for class III implantable devices which they have supplied or been supplied with (Art. 65 para. 1 MedDO and Art. 58 IvDO).

If the incident is subject to the reporting obligation, the corresponding form on the Swissmedic website must be completed in full:

The presentation below on vigilance regarding medical devices (only in german) is given at the Centre for Medical Education (medi) in Bern and covers the following topics:

  1. who is Swissmedic?
  2. what is a medical device?
  3. what is vigilance?
  4. medical devices: obligation to report serious incidents
  5. case studies

The presentation does not contain information on vigilance concerning in vitro diagnostic medical devices, medical devices without a medical purpose or systems and procedure packs.

As the authority responsible for monitoring vigilance, Swissmedic conducts inspections of vigilance systems for medical devices in hospitals. The checklist used for these inspections can be found under this link:

IN615_10_004d_CL Checkliste für die Inspektion von Systemen der Vigilance betreffend Medizinprodukten (PDF, 3 MB, 26.05.2022)(Notification of serious incidents in connection with medical devices and safety notices) Document only available in German, French or Italian

For further information on the role of the person responsible for vigilance relating to medical devices, and on incident reporting by users, please refer to the following information sheets:

New medical devices regulations

New medical devices regulations came into force on 26 May 2021. An information meeting was held (in French and German) on 2 September 2021 to explain the impact of the new regulations on the different players in the Swiss medical devices sector.

Information on the new medical devices regulations (French and German only):

Presentation on requirements pertaining to healthcare institutions:

One presentation dealt with the new vigilance requirements. This presentation is available on the Swissmedic website:

Presentation on medical devices vigilance and market surveillance:

Last modification 16.05.2024

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