MedTech Europe calls for dedicated pathways for breakthrough, orphan and paediatric devices

Europe hosts world-class academic healthcare institutions, strong health systems, and a dynamic innovation ecosystem. Yet, transforming a promising idea into a medical technology that reaches patients and healthcare systems remains challenging due to fragmented pathways and complex regulatory requirements.

To better support Europe’s innovation ecosystem and ensure timely access for patients, the European Union needs special regulatory pathways for innovative, orphan and pediatric devices.

MedTech Europe believes that these special pathways must be formally embedded in legislation, building on existing concepts and lessons learned from current guidance. This paper presents MedTech Europe’s vision for the creation of such pathways.

For further information, please read our full paper below.