The Medical Devices and Pharmaceutical Collaboration Directorate is actively engaged in the Joint Action on Reinforced Market Surveillance of Medical Devices and In Vitro Medical Devices (JAMS 2.0)
This initiative, under the EU4Health Programme, aims to reinforce the market surveillance of medical devices (MDs) and in vitro diagnostic medical devices (IVDs) among member states and harmonise approaches across the European Union.
Concurrent with the ongoing implementation of MD/IVD Regulations, the actions carried out establish a foundation for increased dialogue, facilitating future coordination among Competent Authorities (CAs) through the adoption of aligned and consistent work methods. Through bolstered coordination, JAMS 2.0 enhances the safety of medical devices, thereby effectively contributing to public health protection by ensuring market availability of safe, effective, and good quality devices compliant with regulations. This Joint Action will also facilitate sharing of best practices and development of training modules for MDs/IVDs market surveillance.
Comprising of 8 work packages, JAMS 2.0 provides a platform for 24 CAs across Europe to collaborate via joint inspections, signal detection operations and harmonised market surveillance campaigns. Within this framework, the Medical Devices and Pharmaceutical Collaboration Directorate leads Work Package 5, one of the technical packages, focusing on
· Determining and analysing the present state-of-the-art of signal detection in vigilance
· Establishing a team approach between Competent Authorities in developing and harmonising a framework for MD vigilance signal detection
· Developing the necessary guidance documents to support the integration and implementation of the framework within each Member State and at a European level
· Providing training to Member States on the implementation of the framework including capacity building and digitalisation
The directorate also actively participates in Work Package 6 centred on Inspections and Work Package 8 focused on academic training of experts in the area of medical devices and in-vitro diagnostics. Malta is co-leading 2 tasks within Work Package 8. JAMS 2.0 commenced on 1st November 2023 and relevant work will be conducted over a span of 36 months. It is co-funded by the European Health and Digital Executive Agency (HaDEA) through the EU4Health programme.
Further information is available through the following website:
https://www.camd-europe.eu/joint-action-projects/jams-2-0/