The European Commission publishes today the final of six Regulations implementing the Regulation on Health Technology Assessment (HTA) (Regulation (EU) 2021/2282 of 15 December 2021 on health technology assessment and amending Directive 2011/24/EU) (the HTA Regulation).

The sixth Implementing Regulation is dated 17 October 2025 and establishes procedural rules for joint clinical assessments at the EU level of medical devices (MDs) and in vitro diagnostic medical devices (IVDs) (the Sixth Implementing Regulation – see, attached copy). Those assessments are intended to support EU Member States in their national HTA processes by providing a scientific analysis of clinical evidence on the relative effects of the MD or IVD on health outcomes.

The Sixth Implementing Regulation governs in particular (i) the cooperation of the Member State Coordination Group on HTA (the Coordination Group) and the Commission with notified bodies and expert panels; (ii) the interaction between the Coordination Group and MD/IVD developers, patients, clinical experts and other experts during joint clinical assessments; (iii) rules on the selection and consultation of stakeholder organisations and individual experts in joint clinical assessments; (iv) the format and templates for dossiers with information, data, analyses and other evidence to be provided by MD/IVD developers for joint clinical assessments (see also, Annexes I and II to the Sixth Implementing Regulation); and (v) the format and templates for joint clinical assessment reports and summary reports (see also, Annexes III, IV and V to the Sixth Implementing Regulation).

The Sixth Implementing Regulation will enter into force on 9 November 2025. The HTA Regulation itself has become applicable on 12 January 2025 and its new rules are currently applied only to new oncology medicines and advanced therapy medicinal products. At present, nine joint scientific assessments are ongoing for such medicines.

The first five Implementing Regulations of the HTA Regulation were published on, respectively, 24 May 2024, 21 October 2024, 28 October 2024, 19 December 2024 and 27 January 2025 (see, Van Bael & Bellis Life Sciences News & Insights of 22 October 2024, 28 October 2024, 19 December 2024 and 27 January 2025).