Last updated: 4 October 2022
See updates at the end of the post.
Swissmedic has provided practical interpretation on the requirement of an authorised representative (CH-REP) for drug-device combination products.
Swiss authorised representative (CH-REP)
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).
If the manufacturer of a medical device does not have its registered place of business in Switzerland, its products may only be placed on the market once an authorised representative domiciled in Switzerland has been appointed (Art. 51 para. 1 MedDO). This also applies to manufacturers with their registered place of business in the EU.
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.
The requirements
Combination products are medicinal products with a medical device component.
Below is as attempt to tabulate the requirements for drug-device combination products using the information provided on the Swissmedic website.
| Product category | Applicability of the Medical Devices Ordnanace (MedDO) to the combination product | Requirements to be satisfied by the Medical device component of the drug-device combination product | Requirements to place the product on the market | Is a CH-Rep required? |
|---|---|---|---|---|
| The combination product is an integral, non-separable combination | The MeDO does not apply to combinations which, when placed on the market or put into service, incorporate as an integral part a medicinal product in addition to the device, where the medicinal product assumes a primary function in such combinations. | The medical device component must satisfy the GSPRs set out in Annex I of the Medical Devices Regulation (EU) 2017/745 and para. 2 MedDO. | 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 MAH is responsible for the pharmaceutical quality and safety-related issues connected with the placing on the market of the combination product. The MAH 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 a Swiss authorised representative (CH-REP) 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). |
| The combination product is are placed on the market as a co-packaged unit. | – | The medical device component must satisfy the GSPRs set out in Annex I of the Medical Devices Regulation (EU) 2017/745 and meet the conformity requirements of MedDO (CE mark) taking into account its intended use. | Same as above | Same as above |
| The product is a medicinal product with a referenced medical device component, i.e. the medical device component is not co-packaged with medicinal product (but mentioned in the SmPC and PIL of the medicinal product with which it is supposed to be used) and is intended specifically for use of this product, | The requirements of medical devices legislation must be met in full. | This product must have a CH-REP. | ||
Further information on the CH-REP is provided in this blog post.
Source: Swissmedic website
Updates
| Date | Update |
|---|---|
| 4 October 2022 | Link added at the end of the post to another blog post on the CH-REP |