Swissmedic: Invalid Certification of the Notified Body ECM
On 9 January 2024, the Swiss Medicines Agency Swissmedic informed about critical deficits in the system of medical device regulation.
To ensure safety and efficiency, medical devices and the quality management system of medical device manufacturers are inspected and continuously monitored by notified bodies. The German notified body ECM (ECM-Zertifizierungsgesellschaft für Medizinprodukte in
Europa GmbH, Aachen) used to be such a notified body until its designation expired on 25 May 2020 and has not been renewed by the corresponding German authority. Since then, ECM-certified products have no longer been monitored in accordance with the requirements of the Therapeutic Products Act.
Last year, Swissmedic discovered that ECM certified medical devices of foreign manufacturers were still being sold in Switzerland. In response, the Swiss authority informed the approximately 980 registered Swiss authorised representatives of foreign manufacturers about the problem in June 2023 and asked them to review their mandates.
During the period from July to October 2023, the Swiss authority then carried out extensive research for a sample check. This revealed that 7 of the 15 specifically selected authorised representatives had products with an ECM certificate in their portfolio.
Swissmedic has ordered the authorised representatives concerned to take corrective action to ensure that the products distributed in Switzerland comply with the regulatory requirements.
Source:
Swissmedic: Announcements on market control issues
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