JAMS 2.0 project aims to reinforce the market surveillance of medical devices (MD) and in-vitro medical devices (IVD) in EU/EEA Member States to harmonize approaches in this field across the European Union, and to ensure the continuous improvement of collaboration.
To strengthen market surveillance and harmonise inspection practices, 30 joint inspections of MD/IVD manufacturers were conducted in 14 European countries between March 2024 and July 2025 as part of the Work Package 6 led by Belgian Competent Authority (FAMHP). Among 21 Competent Authorities that participated the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (JAZMP) took active part by organising 6 inspections of Slovenian manufacturers. The report ‘JAMS 2.0 work package 6 – Summary on the performance of joint inspections of manufacturers’ sets out the conclusions of this campaign.
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 were 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.
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.
