This year, the European Medicines Agency (EMA) has already published draft guidelines and a Q&A document on combination products. These include the “Guideline on the quality requirements for drug-device combinations” (EMA/CHMP/QWP/BWP/259165/2019) and the Q&A EMA/37991/2019. Swissmedic will follow these guidelines.
In detail, this means the following: For approval applications for integral combination products, it must be shown from 26 May 2020 that the medical device component fulfills the basic safety and performance requirements determined in Annex I of the new EU MDR if it does not bear the CE marking. An assessment by a designated notified body (Notified Body Opinion) in accordance with Article 117 MDR for integral medical device components of classes Is, Im, Ir, IIa, IIb and III is also required if no certificate from a designated conformity assessment body is available.
According to Swissmedic, practical implementation is based on the
- Guideline on the quality requirements for drug-device combinations (EMA/CHMP/QWP/BWP/259165/2019) as well as the
- Questions & Answers document (EMA/37991/2019)
the European Medicines Agency (EMA). The guideline itself is currently only available as a draft.
Swissmedic will adapt the relevant application forms and the updated guidance “Formal requirements HMV4”. When the EU MDR comes into force in May 2020, the documents will be available online.