The lack of a renewed Mutual Recognition Agreement (MRA) on the medical device legislation between the European Union and Switzerland means that the latter is now considered a third country.
Swissmedic offers guidance, answers to concerns regarding the application of the legislative framework for medical devices and medicinal products and constantly monitors legislation changes and developments, particularly in the EU framework.
Regarding combination products, defined as “medicinal products with a medical device component” (Swissmedic, 2021a), Swissmedic has also clarified their requirements in the guidance which covers all formal requirements for human medicinal products, from the general ones such as packaging, pharmacovigilance and good manufacturing practices, to special requirements concerning Plasma Master Files, radiopharmaceuticals, antidotes, and many more.
An essential distinction is also made between those combination products, resulting as follows:
- Combination products with a non-separable medical device component
- Combination products with a separable medical component. They are additionally divided into:
- Combination products with physical non-separability
- Combination products with use-specific non-separability
Do combination products need a Swiss authorised representative?
To place medical devices on the market, non-Swiss manufacturers need to appoint a Swiss Authorised Representative (CH-REP) to “ensure the existence of a Swiss natural or legal person subject” on the Swiss market (Swissmedic, 2021a).
Since 2021, Swissmedic has published several practical interpretations to clarify whether this requirement also applies to combination products. The last update was published in December 2022.
According to their interpretation, manufacturers of combination products sold as non-separable units, either “integral” or “co-packaged”, do not need to appoint a CH-REP. However, the medical device component should satisfy the requirements detailed in the above-mentioned guidance document and transposed from EMA’s guidelines on quality documentation for medicinal products when used with a medical device
As the Swiss authorities explain, medicinal products require pre-market authorisation. The medical device is already included in this authorisation in a combination product. Therefore, the marketing authorisation holder will assume full responsibility medical device component. Therefore, they will ensure traceability and address any safety-related issues. The holder “also ensures that in the case of co-packaged products, the medical device component cannot be marketed separately.” (Swissmedic, 2022). Hence, there is no need to appoint a CH-REP for non-separable combination products.
Nonetheless, in case of separable combinations (i.e., the medical device is placed on the market as a stand-alone product), the medical device component must comply with the requirements in Art. 1 para. 3 let. b and a CH-REP shall be appointed.
Requirements for importers of combination products
In another practical interpretation, Swissmedic states that MedDO requirements do not apply to importers of authorised non-separable combination products. However, if the medical device component is sold as a separable unit, the requirements must be fully met.
The complete list of requirements for combination products can be found in Section 2.5.15 of the guidance mentioned above on combination products.
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Swissmedic (2021a). ). Practical interpretation – Swiss authorized representative (CH-REP) for combination products. Retrieved on 21 October 2021
Swissmedic (2021b). Practical interpretation – Requirements for importers under the Medical Devices Ordinance in the case of combination products. Retrieved on 17 December 2021.
Swissmedic (2022). Clarification of terminology for combination products (medicinal products with a medical device component). Retrieved on 9 January 2023.
Swissmedic (15/12/2022). Guidance document. Formal Requirements HV4. Retrieved on 9 January 2023.
European Medicines Agency (2022). Quality documentation for medicinal products when used with a medical device – Scientific guideline. Retrieved on 9 January 2023.
Swiss Federal Council. 812.213 Medical Devices Ordinance (MedDO) of 1 July 2020 (Status as of 26 May 2022). Retrieved on 9 January 2023.
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