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: