The legal requirements applicable to professional users for medical device vigilance are set out in Article 59 of the Therapeutic Products Act (TPA, SR 812.21), Articles 65, 66 and 67 of the Medical Devices Ordinance (MedDO, SR 812.213) and Articles 58, 59 and 60 of the Ordinance on In Vitro Diagnostic Medical Devices (IvDO, SR 812.219).
The «Schweizerische Gute Praxis der Materiovigilance im Spital (GPMV-Spital)» is the guideline that describes the legal requirements applicable to hospitals. This document contains all the information relating to the obligations to report serious incidents and the implementation of Field Safety Corrective Actions (FSCA) in hospitals. Its application is mandatory for all hospitals, and any deviations must be assessed accordingly, remedied or justified and documented if necessary.
The implementation of the GPMV-Spital in hospitals is reviewed by Swissmedic as part of administrative proceedings, including inspections, with the aid of the following checklist (which will be updated shortly):
Incident reporting by users
Under the TPA, professional users are required to report serious incidents involving medicinal products to Swissmedic (Art. 59 para. 3 TPA).
In accordance with Art. 66 para. 4 MedDO and Art. 59 para. 4 IvDO, any professional who becomes aware of a serious incident when using devices must report it to the supplier and Swissmedic, in accordance with the timelines set out in the European regulations.
Where the incident is serious and therefore subject to the reporting obligation, the form provided on the Swissmedic website must be fully completed:
Users
www.swissmedic.ch/md-materiovigilance-utilisateurs
For further information on incident reporting by users, please refer to the following information sheet:
Training healthcare professionals in vigilance
To ensure that the vigilance system implemented in the hospital is effective, all relevant hospital personnel must be trained.
The following presentation (only in german, french or Italian) is from a training course given by Swissmedic at a professional school and provides an example of the topics that may be covered during vigilance training:
The content and examples must be adapted to suit the specific institution to better reflect the vigilance processes in place there. The GPMV-Spital provides comprehensive information on all aspects to be taken into account for these trainings.
