The new Regulation (EU) 2017/745 on medical devices (MDR) has been in effect since 26 May 2021. In its publication dated 26 May 2021, Swissmedic provided information on the new requirements for combination products. For practical implementation of Art. 117 of the aforementioned Regulation, Swissmedic refers to the EMA's “Guideline on quality documentation for medicinal products when used with a medical device” (EMA/CHMP/QWP/BWP/259165/2019). A revised version of this was published on 22 July 2021.
Revised versions of Swissmedic's specification documents are also now available. You can find all relevant information in section 2.5.15 of the Guidance document Formal requirements HMV4.
A basic distinction is now made between combination products with a non-separable medical device component according to Art. 2 para. 1 let. f of the Medical Devices Ordinance (MedDO; SR 812.213) and those with a separable medical device component. Non-separable combination products are further divided into those with physical non-separability (described in the EMA Guideline as integral) and those with use-specific non-separability (described in the EMA guideline as co-packaged).
The requirements to be met by the medical device components are described in detail in the Guidance document Formal requirements HMV4 and are equivalent in practice to those in the “Guideline on quality documentation for medicinal products when used with a medical device” (EMA/CHMP/QWP/BWP/259165/2019).
For both categories of non-separable combinations, the marketing authorisation holder bears full responsibility for the whole product, including the medical device component. It also ensures that in the case of co-packaged products, the medical device component cannot be marketed separately.
In the case of separable combinations (described in the EMA guideline as referenced), the medical device component must meet all the conformity requirements set forth in Art. 1 para. 3 let. b MedDO.