New EU Regulation for Joint Scientific Consultations

The European Commission has published Implementing Regulation (EU) 2025/117, which sets out the detailed rules for joint scientific consultations under the Health Technology Assessment(HTA) Regulation. This regulation aims to provide a structured approach for those developing health technologies, facilitating the preparation of joint clinical assessments for medical devices and in vitro diagnostic medical devices (IVDs).

What's changing?
The regulation introduces clear procedures for the submission of consultation requests by those developing the technology, involving interested parties such as clinical experts and patients. It also establishes close collaboration with the European Medicines Agency (EMA), allowing scientific consultations to be carried out in parallel with expert panel reviews, ensuring regulatory alignment and predictability.

Main benefits:

• Precise guidance on clinical evidence requirements;

• Improved cooperation between manufacturers and regulatory bodies;

• Promoting innovation in the medical devices and IVDs sector.

This regulation represents a significant step in the implementation of the HTA Regulation, in force since January 12, 2025, reinforcing the European Union's commitment to the safety and efficacy of medical technologies.

For more details, see the full regulations in PDF below.