EU Health Technology Assessment: public consultation and Joint Scientific Consultations now open
The implementation of the EU Health Technology Assessment (HTA) Regulation has reached a crucial stage. In June 2025, the European Commission introduced two important initiatives. These developments directly affect developers of medical devices, in vitro diagnostic devices, and medicinal products. Both are part of the practical rollout of Regulation (EU) 2021/2282.
Public consultation on joint clinical assessments
From 28 May to 25 June 2025, the European Commission invites stakeholders to share feedback on the final implementing act concerning joint clinical assessments (JCA) of medical devices and in vitro diagnostics. This document represents the last step to complete the legal framework under the HTA Regulation.
The consultation explains how JCAs will function at the EU level. As a result, participants can help improve clarity, transparency, and predictability in the upcoming system.
Participate in the consultation here
Second window now open for Joint Scientific Consultations (JSCs)
Between 2 and 30 June 2025, health technology developers have the chance to apply for the second round of Joint Scientific Consultations (JSCs). These meetings offer an opportunity to align clinical study planning with HTA expectations and prepare effectively for a future JCA.
Available consultation slots
- 29 September–2 October 2025 (briefing document due by 1 September)
- 27–30 October 2025 (briefing document due by 29 September)
- 24–27 November 2025 (briefing document due by 27 October)
- 12–15 January 2026 (briefing document due by 1 December)
To participate, developers must submit their applications via the HTA IT Platform no later than 30 June 2025. Since registration may take several days, early action is highly recommended.
New guidance documents for medical devices and IVDs
In addition to the existing guidance for medicinal products, the European Commission has now released dedicated documents for medical devices and in vitro diagnostics. These new publications aim to support developers in preparing successful JSC applications.
What this means for manufacturers
The transition from national to joint EU-level assessments has already begun. With these two initiatives now active, developers have the chance to:
- Contribute to shaping how JCAs will apply to their technologies
- Gain early scientific feedback on clinical study design
- Prepare in advance and reduce delays in EU market access
Act now
If you are developing a medical device or diagnostic technology for the EU market, this is the right moment to get involved:
- Join the public consultation before 25 June
- Apply for a Joint Scientific Consultation by 30 June
- Stay connected to learn how EU regulatory initiatives may affect your product strategy
