Today, the European Commission launched an online public consultation on joint clinical assessments of medical devices and in vitro diagnostic medical devices at Union level under the HTA Regulation.
This online consultation will be open for responses until 25 June 2025.
This public consultation is focussed on the last implementing act for adoption under the HTA Regulation, which will complete the legislative framework for its implementation. Your contribution can provide important information and insights on the implementation of the Regulation.
On 2 June, the Commission will open the second submission period for joint scientific consultations (JSCs) under the EU Health Technology Assessment Regulation.
JSCs enable health technology developers to consult on the planning of their health technology clinical studies and clinical investigations of a health technology, regarding the information and evidence needed for a subsequent Joint Clinical Assessment.
The submission period is open from 2 to 30 June 2025 to developers of both medicinal product and medical devices.
Developers can apply for consultation slots during this time as follows:
- Start of the procedure 29 September–2 October 2025 (Briefing document by 1 September 2025)
- Start of the procedure 27–30 October 2025 (Briefing document by 29 September 2025)
- Start of the procedure 24–27 November 2025 (Briefing document by 27 October 2025)
- Start of the procedure 12–15 January 2026 (Briefing document by 1 December 2025)
Requests must be uploaded to the HTA IT Platform by 30 June 2025. As access to the platform can take a few days, early registration is recommended.
In addition to the guidance documents for JSCs for medicinal products, the guidance documents for JSCs for medical devices and in-vitro diagnostic medical devices have also been published.
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