Combination products are medicinal products with a medical device component. Combination products can either be non-separable combinations or separable combinations.
EU MDR amendment of 20 March 2023
Regulation (EU) 2023/607 amending the MDR and the IVDR as regards the transitional provisions for certain medical devices and IVDs published
In the EU, Regulation (EU) 2023/607 amending the MDR and the IVDR as regards the transitional provisions for certain medical devices and IVDs was published on 20 March 2023 and included information on the transitional period for medical device certificates issued under the old legislation (MDD).
Swissmedic follows 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.
You can read more on Regulation 2023/607 in this post.
Non-separable combinations
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 of the Medical Devices Regulation (EU) 2017/745 (MDR) (Art. 2 para. 1 let. f and g and para. 2 MedDO).
- For non-separable combinations 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.
Separable combinations
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.
Source: Swissmedic