HTA Regulation Implementing Regulation concerning joint scientific consultations on medical devices and IVDs

The European Commission has published an implementing regulation for the Health Technology Assessment Regulation (HTA Regulation) concerning joint scientific consultations on medical devices and in vitro diagnostic devices .

The purpose of the Regulation is to provide detailed procedural rules for scientific advice in relation to a number of elements including the submission of related requests from health technology developers, and the selection and consultation of stakeholder organisations and patients, clinical and other relevant experts. The purpose of the scientific advice is to permit health technology developers to exchange information with HTA bodies concerning their plans to develop medical devices or in vitro diagnostic medical devices and the suitability of these plans for the assessment process for which the HTA Regulation provides.

The Regulation also provides for cooperation with the European Medicines Agency (EMA) in joint scientific consultation in parallel with an expert panel consultation. The purpose of joint scientific consultations is to ensure that both bodies share relevant information and maintain “synchronized timing”.

The Regulation also provides for close coordination between the HTA secretariat and the EMA to avoid procedural duplications and ensure that all required documents are uniformly accessible to both bodies. The Regulation provides that, by 30 November each year, the Coordination Group should set dates of request periods for joint scientific consultations. There should be at least three request periods each year.

As a derogation from this requirement for 2025, by 31 March 2025 the Coordination Group should set at least one request period for joint scientific consultations on medical devices and in vitro diagnostic medical devices for the year.