As part of the JAMS 2.0 project, 30 joint inspections of medical device manufacturers were conducted within the European Union in 2024 and 2025. These inspections, coordinated by the FAMHP, aim to strengthen market surveillance at EU level and harmonise the operation of inspections.
To strengthen market surveillance and harmonise inspection practices, 30 joint inspections of medical device manufacturers were conducted in 14 European countries between March 2024 and July 2025 as part of the JAMS 2.0 project (Joint Action on Reinforced Market Surveillance of Medical Devices and In Vitro Medical Devices). This inspection campaign, coordinated by the Federal Agency for Medicines and Health Products (FAMHP) with the participation of 21 member states, aimed to harmonise inspection practices and strengthen market surveillance at European level. The report ‘JAMS 2.0 work package 6 - Summary on the performance of joint inspections of manufacturers’ sets out the conclusions of this initiative.
Key findings
• No critical non-conformities were identified, indicating that none of the medical devices inspected posed an immediate threat to public health.
• All inspections revealed at least one non-conformity, underlining the importance of on-site inspections and the need for the industry to continue its efforts to achieve full compliance with regulatory requirements.
• The main non-conformities related to the quality management system, technical documentation, labelling, instructions for use and post-market surveillance. For each non-conformity, the manufacturer was asked to submit a plan to resolve the situation within a reasonable period of time.
Guidelines
The report puts forward targeted guidelines for manufacturers, notified bodies and competent authorities to improve regulatory compliance and continue efforts to harmonise inspection practices.
This campaign has made it possible to test and refine the common framework for joint inspections, strengthened cooperation between the competent authorities involved, and has enabled a fruitful exchange of experience and best practices between European inspectors. The campaign represents a major step towards a more consistent and effective surveillance of the medical devices market in Europe.
More information
Report ‘JAMS 2.0 Work Package 6 - Summary on the performance of joint inspections of manufacturers’