| The European Commission adopted an implementing regulation establishing the rules for joint scientific consultations on medical devices and in vitro diagnostic medical devices, under the Health Technology Assessment (HTA) Regulation. The implementing act provides detailed procedural rules for the joint scientific consultations, also known as scientific advice, covering:the submission of requests from health technology developers;the selection and consultation of stakeholder organisations and patients, clinical and other relevant experts;cooperation with the European Medicines Agency (EMA) where a medical device developer requests a joint scientific consultation to be undertaken, in parallel with an expert panel consultation. Joint scientific consultations enable health technology developers to exchange information with HTA bodies on their development plans for a medical device or an in vitro diagnostic medical device, in scope of the HTA Regulation. They allow developers to obtain guidance on the development of clinical evidence likely to be required for subsequent joint clinical assessments of such devices. The HTA Regulation foresees the adoption of implementing acts, detailing the procedural rules for the different elements in the Regulation. This is the fifth implementing act adopted under the HTA Regulation. The HTA Regulation became applicable on 12 January 2025. More information: Health technology assessment Implementing the EU Health Technology Assessment Regulation Regulation 2021/2282 on Health Technology Assessment |
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