European Commission Adopts Implementing Regulation for Joint Scientific Consultations on Medical Devices
The European Commission has taken a significant step in regulating medical devices by adopting an implementing regulation on January 23, 2025. This regulation establishes the procedural rules for joint scientific consultations on medical devices and in vitro diagnostic medical devices under the Health Technology Assessment (HTA) Regulation.
Key Aspects of the Regulation
The implementing act provides detailed rules covering several critical areas:
- The submission process for requests from health technology developers
- The selection and consultation of stakeholder organizations, patients, and clinical and other relevant experts
- Cooperation with the European Medicines Agency (EMA) when a medical device developer requests a parallel joint scientific consultation and expert panel consultation
Purpose of Joint Scientific Consultations
Joint scientific consultations enable health technology developers to engage with HTA bodies regarding their development plans for medical devices or in vitro diagnostic medical devices that fall under the HTA Regulation. These consultations allow developers to receive guidance on the clinical evidence required for subsequent joint clinical assessments of such devices.
Context within the HTA Regulation
This implementing act is the fifth adopted under the HTA Regulation, which became applicable on January 12, 2025. The HTA Regulation envisages the adoption of implementing acts to detail procedural rules for various elements within the regulation.
Additional Information
For more details on Health Technology Assessment and the implementation of the EU HTA Regulation, please refer to the relevant resources:
