News about GMP/cGMP


EMA: Updated Q&A on Drug-Device-Combination Products under new MDR/IVDR

EMA: Updated Q&A on Drug-Device-Combination Products under new MDR/IVDR

EMA has updated its Q&A document on drug-device combination products by end of June 2021. It includes the current requirements under the Medical Devices Regulation (MDR), which entered into force on 26 May 2021. Marketing authorisation holders of combination products are provided with detailed information on all current adjustments.

Medicinal products that are combined with a medical device in a secondary packaging must take into account the specifications according to MDR/IVDR. These so-called co-packaged products (e.g. reusable pens for insulin cartridges) must be labelled specifically. This should distinguish them from combination products offered in a fixed combination with a medicinal product (integral products, e.g. a single-use dose inhaler), which are considered medicinal products according to the MDR.

  • Co-packaged products must fulfil the corresponding MDR requirements. The device included needs additional information, such as a Unique Device Identifier (UDI). 
  • Single intregral products are subject to Directive 2001/83/EC for medicinal products and are addressed in Article 1, MDR.  

For all combination products, the safety and performance requirements of the MDR must be met. If the products were authorised before 26 May 2021, no variation needs to be submitted to demonstrate compliance. If adjustments still need to be made to meet the requirements, a transition period until 26 May 2024 applies.


EMA: Q&A on implementation of the medical devices and in vitro diagnostic medical devices Regulations ((EU) 2017/745 and (EU) 2017/746)