Combination products are medicinal products with a medical device component. In the case of non-separable combinations (“integral” and “copackaged”), the combination product is not subject to the Medical Devices Ordinance. However, the medical device component must meet the basic safety and performance requirements according to Annex I EU-MDR 2017/745 (Art. 2 para. 1 let. f and g and para. 2 MedDO).
In the case of separable combinations (“referenced”), the medical device component is considered to be a stand-alone medical device. It must meet all conformity requirements of MedDO.
In the EU, an amendment was published to the EU-MDR on 20 March 2023 regarding the transitional period for medical device certificates issued under the old legislation (MDD). Swissmedic is following the European regulations on medical devices and is already implementing enforcement for medical devices according to the requirements of the revised EU-MDR in the transitional phase until the Swiss Medical Devices Ordinance (MedDO) is revised.
For combination products (“integral” and “copackaged”) currently authorised in Switzerland whose medical device component documentation also includes EU conformity certificates (CE certificates) for medical devices, the regulations on the validity of certificates set out in the changes to the EU-MDR will also apply.
If a new certificate is issued in accordance with EU-MDR in this regard, a separate application for variation does not as a rule have to be submitted. These certificates can be submitted together with another quality variation as an editorial change (see section 3.12, subsection 3.12.5 of Guidance document Formal requirements). If no other quality variations are planned in the near future, these certificates can also be submitted as a B.IV.1.z, type IA variation.
However, if the variation or new issuance of a certificate is the result of a significant change to the medical device component which affects/may affect the design or intended purpose or the quality, efficacy or safety of the combination product under medicinal product legislation, a separate application for variation must be submitted.