European Commission HTA-R

Today, 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.

More info at: https://ec.europa.eu/newsroom/sante/newsletter-archives/59483

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