Surveillance of healthcare institutions
Swissmedic is the authority responsible for overseeing the maintenance and reprocessing of medical devices intended for use in hospitals. It is also responsible for controlling of third-party providers who provide medical device maintenance and reprocessing services for hospitals.
In addition, Swissmedic is responsible for monitoring the vigilance (reporting in connection with serious incidents – see the information under Users & operators) in all healthcare institutions. The Cantons are responsible for controlling the maintenance and reprocessing by all other professionals who use medical devices (e.g. medical practices, outpatient clinics, dental clinics).
The legal basis for this requirement is Art. 76 of the Medical Devices Ordinance (MedDO, SR 812.213) and Art. 69 of the Ordinance on In Vitro Diagnostic Medical Devices (IvDO, SR 812.219).
Users in hospitals can contact Swissmedic if they have any questions about medical device maintenance and reprocessing, as well as vigilance in connection to medical devices: questions.devices@swissmedic.ch.
Any users that fall within the jurisdiction of the cantons can contact the cantonal Department of Public Health or the competent cantonal authority (either the Cantonal Pharmacist's Office or the cantonal Medicines Inspectorate depending on the canton) if they have any questions about the maintenance and reprocessing of medical devices.
List of Public Health Departments, Cantonal Pharmacist's Offices, Cantonal Medical Officers or Medicines Inspectorates of the cantons:
Website of the Swiss Association of Cantonal Pharmacists: http://www.kantonsapotheker.ch
The terms “healthcare institution” and “hospital” are defined in Art. 4 of MedDO and IvDO.
According to these definitions, healthcare institutions are organisations whose primary purpose is to provide care or treatment for patients or to promote public health. The term “hospital” is applied to all healthcare institutions in which inpatient treatments for illnesses, inpatient medical rehabilitation and inpatient medical measures for cosmetic purposes are provided by medical or nursing interventions.
Anyone who uses a medical device commercially or applies it to third parties is subject to a legal duty to maintain it, as set out in Art. 49 of the Therapeutic Products Act (TPA). To this end, all maintenance measures that are necessary to ensure the correct functioning and safety of the medical device must be in place. Furthermore, Swissmedic can issue and publish requirements for maintenance measures. These requirements will be deemed to constitute the current state of technology and science (Art. 71 MedDO and Art. 64 IvDO).
According to Art. 4 MedDO and Art. 4 IvDO, the term “maintenance” comprises measures such as mechanical maintenance, software updates, inspection, repair, preparation for first use and reprocessing for reuse or measures to keep a product in functional condition or restore it to such condition. “Reprocessing” is part of maintenance and comprises cleaning, disinfection, sterilisation and similar procedures, such as packing, transport and storage, testing used devices and restoring a device’s technical and functional safety.
According to the TPA, 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 MedDO and the IvDO.
Information on the medical devices regulations which came into force in May 2021 (French and German only):
Presentation on requirements pertaining to healthcare institutions:
Presentation on medical devices vigilance and market surveillance:
Information on devices manufactured and used in healthcare institutions can be found at Frequently Asked Questions on medical devices (swissmedic.ch)
Swissmedic informed in "Pipette", the official media of the Swiss Union of Laboratory Medicine (SULM), about the IvDO which entered into force on 26 May 2022 and its consequences for medical laboratories:
