Adoption of EU HTAR framework rules for joint scientific consultations on medical devices and in vitro diagnostic medical devices

On January 24, 2025, the European Commission adopted an implementing regulation establishing the rules for joint scientific consultations (JSCs) on medical devices and in vitro diagnostic medical devices under the EU HTAR framework.     

The aim of JSCs is to facilitate the process of preparing joint clinical assessments (JCAs) for medical devices and in-vitro diagnostic medical devices, as they will allow health technology developers to obtain guidance from the Member State Coordination Group on HTA (HTACG) on the information, data, analyses and other evidence that are likely to be required from clinical studies for the joint clinical assessment of those devices. JSCs can also facilitate the process of preparing relevant updates of joint clinical assessments for medical devices and in-vitro diagnostic medical devices when the requests meet the eligibility and selection criteria.

The implementing act provides detailed procedural rules for JSCs covering:

• The submission of requests from health technology developers;
• The selection and consultation of stakeholder organizations and patients, clinical and other relevant experts;
• Cooperation with the European Medicines Agency (EMA), where a medical device developer requests a JSC to be undertaken in parallel with an expert panel consultation.

According to the rules, by 30 November each year, the HTACG shall set the dates of request periods for JSCs on medical devices and in-vitro diagnostic medical devices for the subsequent year and the planned number of JSCs for each of those request periods. The HTACG shall set at least three request periods for JSCs on medical devices and in-vitro diagnostic medical devices per year.

See the full details here and here.

This news is just one of about 300 market access news collected by our team in the premium subscription service Market Access Monitor every week from more than 80 organizations. Access our paid service to stay on top of all developments specifically for your products in Europe (reimbursement news) and globally (HTA news). Access is organized as an online Database and email alert formats. Contact us to get a free, three-month, no-obligation trial.