Surveillance of healthcare institutions
Official responsibilities for surveillance
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, reprocessing and vigilance: 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
Healthcare institutions and hospitals
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.
Maintenance and reprocessing of medical devices in healthcare institutions
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.
New medical devices regulations and implications for hospitals
The new Medical Devices Ordinance (MedDO) and Ordinance on Clinical Trials with Medical Devices (ClinO-MD) entered into force on 26 May 2021, and the In vitro Diagnostic Medical Devices Ordinance (IvDO) on 26 May 2022. Swissmedic informed hospital managers in writing of the changes to the legal framework and the associated obligations
Letter of 15 April 2021 regarding «Entry into force of the new Medical Devices Ordinance on 26 May 2021» (available in German):
Letter of 16 May 2022 regarding «Entry into force of the Ordinance on In Vitro Diagnostics Medical Devices (IvDO) on 26 May 2022 amendments due to the new legal basis» (available in German):
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.
One presentation dealt with healthcare institutions and the new requirements facing them. The presentations can be found on Swissmedic’s website by following the links below:
Information on the new medical devices regulations (French and German only):
Presentation on requirements pertaining to healthcare institutions:
Information on devices manufactured and used in healthcare institutions can be found at Frequently Asked Questions on medical devices (swissmedic.ch)
Presentation on medical devices vigilance and market surveillance:
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:
