Swissmedic Calls on CH-REP to Act

Swissmedic is responsible for the Market Surveillance of Medical Devices in Switzerland.

In June, as part of its market surveillance activities, the authority drew attention to the following facts concerning ECM - Zertifizierungsgesellschaft für Medizinprodukte in Europa mbH, Aachen, identification number NB 0481 ( referred to below as ECM). Unfortunately, it is currently not possible to provide specific information to the CH-REPs concerned due to the fact that product registration has not yet been implemented. This information has thus been sent to BEO BERLIN and all CH-REPs registered with Swissmedic and will be published on the Swissmedic website.

Until May 25th, 2020, the ECM was a notified body for the conformity assessment of medical devices in accordance with the old-law European MDD(Medical Device Directive)The designation was not renewed and expired on May 25th, 2020 (source: NANDO). On May 26th, 2021 (i.e. approximately one year after the expiry of the ECM designation), the EU-MDR (Medical Device Regulation) entered into force. According to the EU-MDR (Medical Device Regulationtransitional provisions, although the notified body that issued the legacy certificates under the MDD remains responsible for the adequate surveillance of all applicable requirements for the devices it certifies, the ECM is not responsible for the surveillance of the devices it certifies.

According to the considerations in two German court judgements

1. judgement of the Schleswig-Holstein Administrative Court of 23.06.2021
2. judgement of the Schleswig-Holstein Higher Administrative Court of 23.09.2021

the transitional provisions regarding surveillance by the ECM are not applicable.

A publication in the German Medizinprodukte Journal Heft 4 / 29th Jahrgang November 2022 pages 348-356 summarises these considerations as follows:

«The OVG [Schleswig-Holstein Higher Administrative Court] confirms the decision of the VG [Schleswig-Holstein Administrative Court] […] and states that Art. 120 (3) EU MDR only covers cases in which the designation of the notified body has become invalid under Art. 120 (1) EU MDR, which is why the transitional provisions are not intended to apply to the notified body ECM, since the designation of ECM had expired due to deficiencies in the performance of its tasks.»

BEO BERLIN, its co-operation partner albo-healtcare GmbH and all other CH-REPs are now required:

• to check all products in this regard and, if necessary, to take the necessary measures within the scope of their duties as CH-REPs.
• If a CH-REP terminates the mandate because the manufacturer is in breach of its obligations under the EU-MDR, then it must inform Swissmedic of the termination of the mandate.

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