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European Taskforce for Harmonised Evaluations of Digital Medical Devices (DMDs)

Taskforce mission

 

The European Taskforce for Harmonised Evaluation of Digital Medical Devices (DMDs) was launched in April 2022 with the vision to support integration of technologies with clinical evidence into healthcare procedures, to provide access for patients and promote acceptability thereof across the European Union (EU).

The mission of the taskforce is to provide a European-level blueprint for DMD assessment procedures and methodologies, with the overall goal of enabling a harmonised approach for European assessment supporting national appraisal and reimbursement by statutory health insurance organisations for distinct categories of DMDs.

The taskforce seeks to advise the HTA Coordination Group (HTAR), national responsible authorities and agencies, innovators and policy makers – aligned with EU medical device regulators – on the development of a joint DMD assessment framework and common procedures, including the definition of DMDs based on their application purpose and mutually acceptable evaluation categories.

EIT Health’s role

The taskforce is chaired by the Ministerial Digital Health delegation of the French Ministry of Health and Prevention, co-chaired by the European Network for Health Technology Assessment (EUnetHTA) and co-ordinated by EIT Health. It is operating through and supported by contributors of other European Ministries of Health and agencies competent in the field of DMD evaluation.

The twenty taskforce members are from the academic sector, policy makers, national competent authorities and HTA agency representatives from EU countries such as Austria, Belgium, Finland, France, Germany, Italy, Luxembourg, and Spain.

An External Advisory Board has been set up and involved in the working process to contribute to the final suggestions by sharing perspectives of different stakeholders and experiences from real-world examples.

Areas of work

The aim of the taskforce is to harmonise the nomenclature and taxonomy of DMDs based on their application purpose, to reach consensus on clinical evidence requirements across European countries and to propose a social acceptance framework for DMDs.

The recommendations of the Taskforce will be published in form of a guideline document with recommendation on the EIT Health website and through white papers in the following focus areas:

• Harmonisation of nomenclature and taxonomy of DMDs,

• Joint clinical evidence assessment framework of DMDs based on respective national responsible authorities and agencies’ mandates, and

• Proposals for healthcare system integration and socio-economic requirements for uptake.

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