Harmonisation of assessment processes for combined studies of medicines and medical devices is progressing

The EU Member States have officially endorsed the new strategy for EU's COMBINE programme for combined studies of medicines and medical devices. For the coming years, the programme’s projects have many goals, such as

• A single harmonised assessment process for multi-country combined studies (pilot project)

• Harmonisation of severe adverse event reporting processes

• Clarification of the interfaces between clinical trials and combined studies of medical devices

• Exploration of new opportunities for advising sponsors and facilitation of knowledge exchange among national authorities.

The programme is a collaboration between national authorities responsible for clinical trials and medical devices, the European Commission, the European Medicines Agency (EMA), ethics committees and other stakeholders.

 

COMBINE programme strategy (European Commission, pdf)

European Commission news article 16 December 2024

Previous Fimea news article on the COMBINE programme 27 May 2024