BILLEV PHARMA EAST

NEWS

9 January 2024

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

The Medicines and Healthcare products Regulatory Agency (MHRA) signed a Grant Agreement with the Consumers, Health, Agriculture and Food Executive Agency (Chafea) – an executive agency of the European Commission – to lead a Joint Action on Market Surveillance of Medical Devices.

On 19 October 2016, at the 39th meeting of the Competent Authorities for Medical Devices in Bratislava, Slovakia, the Joint Action in Market Surveillance of Medical Devices (JAMS) was launched.

 

Comprised of 24 Competent Authorities, the Joint Action 2.0 on Reinforced Market Surveillance of Medical Devices and In Vitro Medical Devices (JAMS 2.0) officially started on November 1st, 2023. It will last 36 months, as final results are expected for October 2026.

 

The goal of JAMS 2.0 is to enhance market surveillance of medical devices in EU/EEA member states and harmonize approaches in this field within the European Union. Under the project, competent authorities will share information, best practices, and knowledge. Exchange of information on market surveillance, training, improvement of technical knowledge on new legislation, and the development of inspection methods will take place among member states. These activities will promote collaboration among inspectors and harmonization of approaches at the EU level. The joint action will also foster cooperation among competent authorities of EU/EEA member states and establish unified procedures for conducting market surveillance campaigns for medical devices. In parallel with the ongoing implementation of medical device regulations, these activities will lay the groundwork for improved dialogue and easier coordination of work procedures among competent authorities of EU/EEA member states. The strengthened coordination facilitated by the joint action will contribute to greater safety of medical devices and, consequently, safeguard public health.