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).
According to Art. 66 para. 4 MedDO, 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 MDR-EU). Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices (MDR-EU).
The terms "incident" and "serious incident" are defined in Art. 2, numbers 64 and 65.
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);
- designate an appropriate competent person with medical or technical training (vigilance officer) with responsibility for ensuring compliance with the obligation to report to Swissmedic (Art. 67 para. 2 MedDO);
- 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);
- 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).
If the incident is subject to the reporting obligation, the corresponding form on the Swissmedic website must be completed in full: