PROJECT NAME

Reinforced market surveillance of medical devices and in-vitro devices (JAMS 2.0)

SUMMARY

JAMS 2.0 aims to reinforce the market surveillance of medical devices between Member States and to harmonise approaches across the European Union. This project is divided into 4 technical work packages (WP) covering different aspects of market surveillance. Each WP provides opportunities under which information, best practices, knowledge and resources will be shared between Competent Authorities (CA). WP5 (Signal detection) will work towards supporting exchanges of market surveillance information between CAs by harnessing data collected across the market. WP6 (Inspection) will seek to establish current practices and support the development of inspection methods through the experience of joint inspections performed by a team of inspectors from different Member States. Activities will promote the cooperation of inspectors and enforce the harmonization of inspections at EU level. Likewise, WP7 will aim to establish common procedures to conduct market surveillance campaigns, prompting collaboration between CAs. WP8 (MD / IVD University) will create training tools to develop skills uniformly and increase technical knowledge of the MD / IVD Regulations across the CA network and beyond. These activities will be supported by 4 cross-cutting work packages (Coordination, Dissemination, Evaluation and Sustainability) to warrant the successful implementation of the action and its outcomes in the long term. Parallel to the ongoing implementation of MD/IVD Regulations, the actions carried out will lay the ground work to increased dialogue and facilitate future coordination and collaboration between CAs through the adoption of aligned and consistent work methods. By strengthening coordination, the project will help to increase the safety of medical devices and therefore, contribute effectively to public health protection, by ensuring that medical devices available on the market are safe, perform as intended and remain compliant with the regulations in place.

DURATION OF THE PROJECT

1.11.2023 – 30.10.2026

BUDGET

4,84 million

EC co-financing 3,87 million (80%)

PARTNERS                                                          

24 EU/EEA members

Coordinator: ANSM (France)

Beneficiary partners: FAHMP (Belgium), AGES (Austria), INFARMED (Portugal), MoH (Croatia), MoH (Cyprus), SÚKL (Czech Republic), DKMA (Denmark), TERVISEAMET (Estonia), BfArM (Germany), FIMEA (Finland), EOF (Greece), LYFJASTOFNUN (Iceland), AEMPS (Spain), NNGYK (Hungary), HPRA (Ireland), MoH (Italy), MMA (Malta), NoMA (Norway), MPA (Sweden), NAMMDR (Romania), JAZMP (Slovenia), URPLWMIPB (Poland), Ministry VWS (Netherlands), FCSAI (Spain)

ROLE OF JAZMP

JAZMP will act as a leader of Work Package 4 – Sustainability that will ensure sustainability of project’s deliverables and participate in Work Package 5 – Signal detection in the area of medical device vigilance.

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 European Health and Digital Executive Agency (HaDEA). Neither the European Union nor HaDEA can be held responsible for them.