Intexo Società Benefit (A ProductLife Group Company) reposted this
🔔Today marks a significant milestone in the medical device industry with the publication of the Implementing Act on Joint Scientific Consultation for Medical Devices and In Vitro Diagnostic Medical Devices in the Official Journal of the European Union 🚀 This is the fifth implementing act adopted under the Health Technology Assessment (HTA) Regulation. 🔍 What Does This Act Cover? 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. 💡 Why This Matters Joint scientific consultations enable health technology developers to exchange information with HTA bodies on their development plans for medical devices and in vitro diagnostic medical devices in scope of the HTA regulation. This collaboration ensures the development of robust clinical evidence needed for subsequent joint clinical assessments. It is available as of today in the 24 EU official languages here: https://lnkd.in/drm-ENTn ProductLife Group #marketaccess #patientaccess
