News about GMP/cGMP

08.11.2019

Swissmedic adapts requirements for combination products to EU

The Swiss Agency for Therapeutic Products (Swissmedic) is working on adapting the requirements for combination products to the new EU Medical Devices Regulation (MDR). A notification was published on the Swissmedic website on 5 November 2019.

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 fulfils 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, the 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.


Sources:

EMA: Guideline on the quality requirements for drug-device combinations (draft)

EMA: Questions & Answers on Implementation of the Medical Devices and In Vitro Diagnostic Medical Devices Regulations ((EU) 2017/745 and (EU) 2017/746) 

Swissmedic: Revised requirements regarding combination products



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