Wir möchten alle Hersteller von Medizinprodukten der Klasse 1 an das bevorstehende Ende der Übergangsfrist für die Kennzeichnung erinnern.
Until July 31st, 2023, it is sufficient to provide the CH-REP information on a document enclosed with the product. From August 1st, 2023, the information must be provided on the label. The information on the economic operators includes the name and address of the registered establishment. For higher classified medical devices, this labelling requirement has existed for some time.
The requirements applicable to the devices must be fulfilled at the time they are placed on the market. Devices that were imported into Switzerland before the new regulations came into force or were already in stock with distributors in Switzerland before the new regulations came into force are considered in the European context to have been placed on the market in accordance with the old law and may continue to be made available on the market. A subsequent notification of the importer as well as the CH authorised representative incl. labelling obligations is not required.
- Reminder: If the manufacturer of a serious everyday safety problems is not domiciled in Switzerland, its products may only be placed on the market in Switzerland if an authorised representative domiciled in Switzerland has been appointed. This also applies to manufacturers domiciled in the EU/EEA.
The designation of the authorised representative applies at least to all products of a generic product group.
Do you have any questions on the topic? Please feel free to contact us. by phone or e-mail.
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