HTA Regulation - European Commission Publishes Implementing Regulation containing Procedures for Joint Scientific Consultations on Medical Devices
- 27/01/2025
- News
The European Commission publishes today the fifth 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) (see, Van Bael & Bellis Life Sciences News & Insights of 15 December 2021 and Van Bael & Bellis Life Sciences News & Insights of 22 December 2021) (the HTA Regulation).
The fifth Implementing Regulation establishes procedural rules for joint scientific consultations on medical devices (MDs) and in vitro diagnostic medical devices (IVDs). Those consultations are intended to facilitate the generation of the information, data, analyses and other evidence that are likely to be required for the subsequent joint clinical assessment of that MD or IVD (see, Articles 16-21, HTA Regulation) (Commission Implementing Regulation (EU) 2025/117 of 24 January 2025 “laying down rules for the application of Regulation (EU) 2021/2282 with regard to the procedures for joint scientific consultations on medical devices and in vitro diagnostic medical devices”; the Fifth Implementing Regulation – see, attached copy).
The Fifth Implementing Regulation governs in particular (i) the submission of requests from MD and IVD developers; (ii) the selection and consultation of stakeholder organisations and patients, clinical experts and other experts; and (iii) cooperation with the European Medicines Agency when a MD developer requests a joint scientific consultation to be carried out in parallel with an expert panel consultation.
The Fifth Implementing Regulation will enter into force on 16 February 2025. While the HTA Regulation itself has become applicable on 12 January 2025, the new rules are currently applied only to new oncology medicines and advanced therapy medicinal products. Selected high-risk MDs will also be assessed under the new rules as of 2026. Orphan medicines will be added in January 2028 and, as of January 2030, the joint assessment work is expected to cover all new medicines.
The first four Implementing Regulations of the HTA Regulation were published on, respectively, 25 May 2024, 18 October 2024, 28 October 2024 and 19 December 2024 (see, Van Bael & Bellis Life Sciences News & Insights of 22 October 2024, Van Bael & Bellis Life Sciences News & Insights of 28 October 2024 and Van Bael & Bellis Life Sciences News & Insights of 19 December 2024).
