Swissmedic, the Swiss Agency for Therapeutic Products, is responsible for carrying out the control tasks in Switzerland. In the framework of market surveillance of medical devices, Swissmedic performs random tests or inspections following the receipt of suspicion reports. In the case of any non-conformities, the Agency proceeds with necessary corrective actions to restore the device’s conformity.
In January 2024, Swissmedic announced a new organizational structure for the market surveillance activities of the Agency, ad published the results on medical devices’ checks with certification from the former notified body ECM.
New organisational structure with separate Medical Devices Surveillance Sector
From 1 January 2024, the new Medical Devices Surveillance Sector of Swissmedic has been assigned market surveillance activities in Switzerland. Previously under the Market Surveillance Sector, this surveillance unit oversees the safety of clinical trials, materiovigilance, monitors the market of medical devices, as well as the maintenance and processing of medical devices in hospitals.
In the context of an enhanced market surveillance, the Swiss legislation on medical devices and IVD medical devices introduces the registration of economic operators and medical devices in Swissdamed. Swissdamed is currently under development and expected to be functional this year. In the meanwhile, Swiss manufacturers, importers, and authorised representatives have to register with Swissmedic directly.
Monitors of medical devices with ECM certification
In January 2024, Swissmedic published the results of their controls on medical devices certificated by ECM. ECM-Zertifizierungsgesellschaft für Medizinprodukte in Europa GmbH (based in Achen, Germany), with identification number 0481, was a notified body designated to certify high-risk devices. Authorities did not renew their notified body status and since May 2020, ECM can no longer certify medical devices.
However, products certified by ECM are still on the Swiss market and therefore, Swissmedic informed hundreds of authorised representatives about the expiry of the notified body status and decided to carry out control activities between July and October 2023. To further investigate the matter, the Agency selected a sample of 15 authorised representatives and assessed that seven authorised representatives were informed about the expiration of the notified body status but did not take measures to address this. Therefore, these authorised representatives did not observe their duties according to the Therapeutic Products Act. Authorised representatives are responsible for formal and safety-relevant interests of medical devices and also liable for defective products jointly with the manufacturer.
CH-REP: why you need an authorised representative
Non-Swiss based manufacturers must designate a Swiss-based Authorised Representative, also if based in the EU and compliant with the EU Regulations. To ensure compliance with the post-market surveillance obligations, Obelis, as your CH-REP, supports manufacturers with their registration obligations, assists them with complaints and incidents’ reports, and cooperates with the Swiss competent authority.
Are you interested in selling your medical devices in Switzerland? Obelis can act as your Swiss Authorised Representative and turn your Swiss journey into a success story! Contact us today.
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