The Heads of Health Technology Assessment Agencies Group (HAG) warmly welcomes the adoption by the European Commission, on 24 January 2025, of the implementing act establishing the rules for joint scientific consultations on medical devices (MD) and in vitro diagnostic medical devices (IVD), under the Health Technology Assessment (HTA) Regulation.
This implementing act provides the procedural rules for joint scientific consultations on MD and IVD, which covers the submission of requests from health technology developers, and the selection and consultation of stakeholder organisations as well as patients, clinical and other relevant experts. It also outlines the rules and procedures for cooperation with the European Medicines Agency, where joint scientific consultations on medical devices are conducted in parallel with expert panel consultation.
Joint scientific consultations allow health technology developers to obtain guidance on the information, data, analyses and other evidence that are likely to be required from clinical studies for the subsequent joint clinical assessment.
According to its Annual Work Programme, the Coordination Group on Health Technology Assessment (HTACG) is planning to initiate between one and three joint scientific consultations for medical devices in 2025. The number of joint scientific consultations will likely increase over the coming years. Requests for joint scientific consultations for MD and IVD are to be submitted between 2nd and 30th June 2025. For more information on joint scientific consultations click here.
