Report on joint inspections at EU level published – Fimea participates in strengthening market surveillance in the EU
A recent report of the JAMS 2.0 project presents the results of 30 joint inspections of medical device manufacturers carried out in 14 EU Member States between March 2024 and July 2025. JAMS 2.0 is part of the EU4Health programme and involves 24 European Supervisory Authorities.
The Medical Devices Regulation obligates the authorities in Member States to take joint market surveillance measures, such as joint inspections. Their aim is to strengthen the effectiveness of market surveillance, harmonise the activities of the authorities at the EU level and support the authorities of the Member States in the implementation of the duties referred to in the Regulation.
Key observations from joint inspections
- No critical non-conformities were identified, which indicates that the inspected devices did not pose an immediate risk to public health.
- All inspections revealed at least one non-conformity, which highlights the importance of on-site inspections and the need to further improve conformity.
- Non-conformities were linked especially to quality systems, technical documentation, labelling, instructions for use and post-market monitoring. The manufacturers were required to present corrective actions within a reasonable time.
The report also contains recommendations for manufacturers, notified bodies and authorities to strengthen regulatory compliance and to develop an EU-level audit methodology.
Fimea actively involved in EU cooperation
Fimea promotes the harmonisation of inspection activities in the EU by participating both in joint inspections and in the development of methods. Between 2024 and 2025, the inspectors from Fimea’s unit for the supervision of medical devices participated in several joint inspections in different EU Member States. In addition, Fimea has been involved in developing joint inspection methods in close cooperation with the authorities of the other Member States.
Read more:
Website of the EU4Health project (European Commission)
Co-funded by the European Union. The views and opinions expressed are only those of the authors and do not necessarily reflect the views of the European Union or the European Health and Digital Executive Agency (HaDEA). Neither the European Union nor HaDEA can be held responsible for them.
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