About JAMS 2.0: Joint Action on Reinforced Market Surveillance of Medical Devices and In Vitro Medical Devices

The Joint Action on Reinforced Market Surveillance of Medical Devices and In Vitro Medical Devices (JAMS 2.0) aims to reinforce the market surveillance of medical devices (MDs) and in vitro devices (IVDs) between Member States and harmonise approaches across the European Union.

Parallel to the ongoing implementation of MD/IVD Regulations, the actions carried out lay the ground work to increased dialogue. This will facilitate future coordination between Competent Authorities (CAs) through the adoption of aligned and consistent work methods.

By strengthening coordination, JAMS 2.0 helps to increase the safety of medical devices. Therefore, it will 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.

The upcoming work, divided into 8 work packages, will create opportunities for 24 CAs to collaborate by different means: joint inspections, signal detection operations and harmonised market surveillance campaigns. Co-funded by the European Health and Digital Executive Agency (HaDEA) through the EU4Health programme, this Joint Action will also allow to share best practices and develop trainings on Market Surveillance of MDs/IVDs.

After several months of preparation, all Work Package Leaders were invited to exchange on the project and agree on the coordination plan for the 3 years to come during the Kick-off Meeting in Paris, on November 14th and 15th, 2023.

This meeting, which were also attended by representatives from HaDEA and the European Commission (DG Santé), marked the official launch of the Joint Action. JAMS 2.0 will be conducted over a period of 36 months and started on November 1st, 2023.

Overview of the Joint Action on Reinforced Market Surveillance for Medical Devices and In Vitro Medical Devices
Overview of the Joint Action on Reinforced Market Surveillance for Medical Devices and In Vitro Medical Devices

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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.