European Commission 17 October 2025, Commission Implementing Regulation (EU) 2025/2086 of 17 October 2025 laying down, pursuant to Regulation (EU) 2021/2282 on health technology assessment, procedural rules for the interaction during, exchange of information on, and participation in, the preparation and update of joint clinical assessments of medical devices and in vitro diagnostic medical devices at Union level, as well as templates for those joint clinical assessments

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European Union · · · Cited by 2 · 17-10-2025

Article 1. Subject matter
Article 2. Provision of information to the health technology developers on the selection of medical devices for joint clinical assessment
Article 3. Provision of information by the health technology developer upon the certification of the device
Article 4. Exchange of information with the notified body
Article 5. Provision of information to the expert panels
Article 6. Provision of information to the Coordination Group
Article 7. Provision of information to the health technology developer about the start of the scoping process
Article 8. Selection of individual experts for joint clinical assessments
Article 9. Professional secrecy obligations of individual experts
Article 10. Consultation of stakeholder organisations during joint clinical assessments
Article 11. Assessment scope proposal
Article 12. Finalisation of the assessment scope
Article 13. Assessment scope explanation meeting
Article 14. Dossier and additional data for joint clinical assessment to be provided by the health technology developer
Article 15. Commission’s confirmation of the dossier for a joint clinical assessment
Article 16. Draft joint clinical assessment and summary reports
Article 17. Finalisation of the revised draft joint clinical assessment and summary reports
Article 18. Re-initiation of joint clinical assessments
Article 19. Updates of joint clinical assessments
Article 20. Correspondence during joint clinical assessments
Article 21. Confidentiality requests
Article 22. Personal data processing
Article 23. Entry into force
ANNEX I. TEMPLATE FOR THE DOSSIER FOR THE JOINT CLINICAL ASSESSMENT OF A MEDICAL DEVICE

Official Journal
of the European Union

L series

2025/2086

20.10.2025

COMMISSION IMPLEMENTING REGULATION (EU) 2025/2086

of 17 October 2025

laying down, pursuant to Regulation (EU) 2021/2282 on health technology assessment, procedural rules for the interaction during, exchange of information on, and participation in, the preparation and update of joint clinical

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