EMA’s Support for EU Regulation on High-Risk Medical Devices and Health Technologies

The European Medicines Agency (EMA) has announced a new regulation that will create a framework for the assessment of selected high-risk medical devices in the European Union. This regulation aims to help national authorities make more informed decisions on the pricing and reimbursement of health technologies.

EMA will play a key role in supporting the implementation of this new legislation in three main areas. Firstly, it will support the timely conduct of joint clinical assessments (JCA) by the HTA Coordination Group to establish the relative clinical effectiveness and safety of new health technologies compared to existing ones. EMA will provide relevant information from its own regulatory assessments to aid in this process.

Secondly, EMA will collaborate with the HTA Coordination Group in parallel joint scientific consultations (JSC) to provide scientific advice to technology developers and facilitate the generation of evidence that satisfies the needs of both regulators and HTA bodies. Lastly, EMA will exchange information on upcoming applications and future health technologies for planning purposes and horizon scanning.

The regulation emphasizes the value of cooperation between decision-makers, such as regulators and HTA bodies, in evaluating the benefits and risks of medicines. EMA has been working closely with the European Commission, EU Member States, and stakeholders to prepare for the implementation of this regulation.

Initially, the new rules will apply to new active substances for cancer treatment and all advanced therapy medicinal products (ATMPs). They will later be expanded to orphan medicinal products in 2028 and all centrally authorized medicinal products by 2030. Selected high-risk medical devices will also be assessed under the HTA Regulation starting in 2026.

EMA now has a legal obligation to notify the European Commission when it receives submissions for marketing authorization applications for medicinal products in the scope of JCA. The HTA Coordination Group estimates that it will need to conduct 17 JCAs for cancer medicines and 8 JCAs for ATMPs in 2025.

Overall, this new regulation marks a significant step towards enhancing the assessment and evaluation of high-risk medical devices in the EU, ultimately leading to more informed decisions on pricing and reimbursement for these health technologies.