European Taskforce for Harmonised Evaluation of DMDs
The European Taskforce for Harmonised Evaluation of Digital Medical Devices pursues the goal of harmonising evaluation procedures for patient-centred digital medical devices (DMDs) within the European Union (EU). The taskforce is seeking candidates for the external advisory group to review, challenge and support the work of the taskforce with relevant use cases to underpin recommendations.
The work of the taskforce comprises three work packages:
- WP1, co-led by representatives Luxembourg Health Directorate and HAS – aims to harmonise the taxonomy of DMDs based on their application type,
- WP2, co-led by representatives of HAS, BfArM and HeKA – strives for consensus on a joint clinical evidence assessment framework of DMDs based on respective national responsible authorities and agencies’ mandates, and
- WP3, proposes a social health evaluation framework to meet socio-economic requirements of DMD acceptability and healthcare system integration aspects.
The recommendations for harmonising clinical criteria and methodologies for evaluating DMDs resulting from the three work packages will be presented at the Digital Medicine Conference Luxemburg on October 26-27, and published in form of a consensus paper.
In order to arrive at robust, real-world-ready recommendations for the harmonisation of the evaluation of DMDs in the EU, it is crucial to incorporate the input of relevant stakeholders representing the European DMD ecosystem. For this purpose, an external advisory group will be set up, to contribute to the final suggestions by sharing perspectives of different stakeholders and experiences from real-world examples.
Are you interested in delivering relevant use cases to underpin the taskforce’s recommendations? Apply to join our external advisory group by September 4 2022.