Medical devices in combination products

Swiss authorised representative (CH-REP), importer, labelling for medical devices (MD) combined with medicinal products

There are three different types of combination products: The integral medical devices (e.g. prefilled syringes, pre-loaded powder inhalers), the enclosed medical devices (e.g. measuring cups, measuring spoons) and the medical devices which are referenced in a medicinal product information but are on the market as independent medical devices. All three groups must meet the general safety and performance requirements (MDR 2017/745, Annex I). However, the extent to which Chapter III of Annex I (Labelling) is applicable to integral and enclosed MDs is the subject of further decisions by Swissmedic. The following guideline provides information for the European area. Chapter 6.1.1, in the last section, is particularly important. It has not yet been clarified whether Swissmedic will also implement this extended labelling requirement in Switzerland.

For integral and enclosed MDs, Swissmedic's practical interpretation indicates that these medical devices do not require a CH-REP. However, it is not yet clear whether the importer must be notified (as a rule also the marketing authorisation holder of the medicinal product). MDs that come onto the market independently - even if they are mentioned in a medicinal product information leaflet - are regarded as completely normal MDs and must fulfil all the requirements for CH-REP, importer and labelling.

The requirements for the MD in the medicinal product dossier are defined in the guideline Formal Requirements HMV4, chapter 2.5.15.

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Any questions?
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Dr. Katharina Oehler
Scientific and Managing Director
T +41 44 787 70 20
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