The revision of the Medical Devices Ordinance (MedDO, SR 812.213) in the context of pending agreements between Switzerland and the EU introduced the role of the authorised representative for medical device manufacturers based in a country outside Switzerland (Swiss authorised representative, CH-REP). The authorised representative is responsible for the formal and safety-related issues connected with the placing on the market of the device. This ensures the existence of a Swiss natural or legal person subject to the legislation (see also FAQ – General – Economic stakeholders – Authorised representative (Switzerland)).
Combination products are medicinal products with a medical device component.
Where this is an integral, non-separable combination, the Medical Device Ordinance does not apply to the combination product and the medical device component must satisfy the general safety and performance requirements set out in Annex I MDR (Art. 2 para. 1 let. f and g and para. 2 MedDO).
For combination products that are placed on the market as co-packaged unit, the medical device component must satisfy the general safety and performance requirements set out in Annex I MDR and meet the conformity requirements of MedDO (CE mark) taking into account its intended use.
To be placed on the Swiss market, these combination products require an authorisation for a ready-to-use medicinal product. The medical device component is part of the authorisation application. In Switzerland, the marketing authorisation holder is responsible for the pharmaceutical quality and safety-related issues connected with the placing on the market of the combination product. The marketing authorisation holder for the combination product assumes full responsibility for the medical device component and safety-related issues; traceability is ensured. There is no need to appoint and state additionally a Swiss authorised representative (CH-REP) for the medical device component of integral combination products and combination products that are placed on the market co-packaged, provided that the medical device is not placed on the market as a stand-alone product (Art. 4 para 1 let. a and b MedDO).
However, where the product concerned is a medicinal product with a referenced medical device component, that means the medical device component is not co-packaged with medicinal product and is intended specifically for use of this product, the requirements of medical devices legislation must be met in full, i.e. this product must also have a CH-REP.