Today, the European Commission launched an online public consultation on the draft implementing act on joint scientific consultations on medical devices and in vitro diagnostic medical devices at Union level under the Health Technology Assessment (HTA) Regulation.
This online consultation will be open for responses until 26 November 2024.
Your contribution can provide important information and insights on the implementation of the HTA Regulation.
The draft implementing act provides detailed procedural rules for the joint scientific consultations, covering:
- the submission of requests from health technology developers for joint scientific consultations on medical devices and in vitro diagnostic medical devices;
- the selection and consultation of stakeholder organisations and patients, clinical experts and other relevant experts in such joint scientific consultations;
- cooperation with the groups of independent experts (expert panels) which support the scientific assessment and advice in the field of medical devices and in vitro diagnostic medical devices. This cooperation will be relevant for cases where a health technology developer requests the joint scientific consultation to be carried out in parallel with the expert panel consultation.
The HTA Regulation foresees the adoption of implementing acts, detailing the procedural rules for the different elements in the Regulation.
The draft implementing act on joint scientific consultation for medicinal products was recently also subject to public consultation from 1 to 29 October 2024.
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