Fimea participates in an EU4Health project focusing on market surveillance of medical devices

The Finnish Medicines Agency Fimea participates in JAMS 2.0, a joint project funded by the European Commission and part of the EU4Health programme. The aim of the project is to harmonise market surveillance of medical devices (incl. IVD devices, medical devices intended for in vitro diagnostics) in the European Union by supporting

• regular exchange of market surveillance information between Member States’ competent authorities;
• cooperation related to the implementation of the market surveillance measures;
• the cooperation of inspectors;
• joint inspections of manufacturers and other economic operators to harmonise the inspection activities at Union level.

The total budget of the JAMS 2.0 project (Joint Action on Market Surveillance for Medical Devices) is EUR 4.8 million, of which 80% will be covered with the EU4Health funding from the European Commission. The project was officially launched on 1 November 2023 and it will end in October 2026. A total of 24 European agencies conducting surveillance of medical devices participate in the project.

FIMEA participates in two work packages

The JAMS 2.0 project consists of a total of eight work packages, of which Fimea participates in two.

The work package focusing on inspections aims to harmonise the inspection activities targeted at manufacturers and other economic operators (e.g., authorised representatives, importers, distributors) in accordance with the MD Regulation (EU) 2017/745 and the IVD Regulation (EU) 2017/746. Fimea will have a central role especially in the harmonisation of inspections focusing on other economic operators. 

The work package concentrating on incident reports aims to enhance the utilisation of information received from incident reports in the planning of proactive market surveillance.

Read more:

Website of the EU4Health project (European Commission)

JAMS 2.0 LinkedIn website

Co-funded by the European Union. Views and opinions expressed are however those of the author(s) only and do not necessarily reflect those of the European Union or the European Health and Digital Executive Agency (HaDEA). Neither the European Union nor the granting authority can be held responsible for them.