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

Ref. Ares(2025)4300616 - 28/05/2025 EUROPEAN COMMISSION Brussels, XXX […](2025) XXX draft COMMISSION IMPLEMENTING REGULATION (EU) …/... of XXX 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 (Text with EEA relevance) This draft has not been adopted or endorsed by the European Commission. Any views expressed are the preliminary views of the Commission services and may not in any circumstances be regarded as stating an official position of the Commission. COMMISSION IMPLEMENTING REGULATION (EU) …/... of XXX 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 (Text with EEA relevance) THE EUROPEAN COMMISSION, Having regard to the Treaty on the Functioning of the European Union, Having regard to Regulation (EU) 2021/2282 of the European Parliament and of the Council of 15 December 2021 on health...