ANNEXES to the COMMISSION IMPLEMENTING REGULATION (EU) .../... laying down, pursuant to Regulation (EU) 2021/2282 on health technology assessment, procedural rules for the interaction during, exch...

Ref. Ares(2025)4300616 - 28/05/2025 EUROPEAN COMMISSION ANNEXES to the Brussels, XXX […](2025) XXX draft ANNEXES 1 to 5 COMMISSION IMPLEMENTING REGULATION (EU) .../... 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 ANNEX I TEMPLATE FOR THE DOSSIER OF THE JOINT CLINICAL ASSESSMENT OF A MEDICAL DEVICE The provision of information, data, analysis and other evidence in the dossier shall follow international standards of evidence-based medicine. The health technology developer may also consult, if available, the methodological guidance adopted by the Member State Coordination Group on Health Technology Assessment (‘Coordination Group’) under Article 3(7), point (d), of Regulation (EU) 2021/2282 where applicable and describe and justify any deviations from that guidance. The information requested in the dossier template shall be provided in a clear format, preferably in tabular format when possible. Revision history Unnecessary lines shall be deleted. If needed, lines may be added. Version Document Legal reference Submission date Commission’s check date V0.1 Initial...