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. Non-Swiss manufacturers need to appoint a Swiss Authorized Representative (CH-REP) to “ensure the existence of a Swiss natural or legal person subject” on the Swiss market (Swissmedic, 2021).
On September 21, 2021, Swissmedic published a practical interpretation to clarify whether this requirement also applies to combination products, which are defined as “medicinal products with a medical device component” (Swissmedic, 2021).
According to their interpretation, manufacturers of combination products sold as co-packaged units do not need to appoint a CH-REP, but the medical device component should nevertheless “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” (Swissmedic, 2021).
As the authorities explain, medicinal products require a pre-market authorization: in a combination product, the medical device is already included in this authorization, as it is considered an integral part of the product. The marketing authorization holder will therefore assume full responsibility also for the medical device component: they will ensure traceability and address any safety-related issues. Hence, there is no need to appoint a CH-REP.
Nonetheless, where the combination product is not sold as a co-packaged unit (i.e., the medical device is placed on the market as a stand-alone product), MedDO requirements will fully apply and a CH-REP shall be appointed.
Swissmedic (2021). Practical interpretation – Swiss authorised representative (CH-REP) for combination products. Retrieved on 21 October 2021 at https://www.swissmedic.ch/swissmedic/en/home/news/mitteilungen/ch-bevollmaechtigter-kombiprodukte.html