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[Press Release] Towards a European evaluation framework for digital medical devices (DMDs) in the European Union – Launch of a European taskforce

26th October 2022

The objective of the European taskforce is to reach a mutual understanding between competent agencies with competences in health technology assessment for digital medical devices (DMDs) at national level, in order to harmonise the assessment criteria  in the European Union. The first results of the three work packages were presented at the Digital Medicine Conference in Luxembourg on October 26-27.

The taskforce is chaired by the Ministerial Delegation for Digital Health (DNS) of the French Ministry of Health, co-chaired by the European Network for Health Technology Assessment (EUnetHTA) and coordinated by EIT Health. The University of Luxembourg is responsible for rapporteurship. The taskforce brings together academic experts in the field as well as representatives of health technology assessment (HTA) agencies from several European countries, including Germany, France, Luxembourg, Finland, Belgium, Austria, Denmark, Italy and Spain.

France and Germany, two major countries with newly established or upcoming fast track mechanisms for the reimbursement of DMDs have been associated at the core of this taskforce. Both have developed new HTA procedures linking different DMD definitions to the evidence generation required to test their clinical effectiveness. For France, next to the DNS, representatives from the French National Authority for Health (HAS), the National Institute of Health and Medical Research (Inserm), the French National Institute for Research in Digital Science and Technology (Inria) and Université Paris Cité (UPCité) are driving some of the work. For Germany, the Federal Institute for Drugs and Medical Devices (BfArM) which is responsible for the fast track process for digital health applications (DiGA) is actively participating.

The three work packages of the taskforce have kicked off their work in the second quarter of 2022 as part of the French presidency of the council of the EU initiatives, and are focusing on the following themes:

  • Work package 1: Propositions to harmonise the taxonomy for different types of DMDs according to their scope of application
  • Work package 2: Recommendations to harmonise clinical requirement to assess DMDs while respecting the mandates of national authorities with a questionnaire currently being administered to the HTA agencies of the 27 Member States
  • Work package 3: Proposition of an evaluation framework to include the socio-economic dimension of DMDs in the context of their integration into health systems

In order to arrive at robust, real-world-ready recommendations for harmonised evaluation criteria of DMDs, an External Advisory Group has been set up following a call for applications to contribute to the final suggestions of the taskforce. The role of the Advisory Group is to evaluate the work of the taskforce, to provide concrete use cases, to support and disseminate the work of the taskforce. The work of the External Advisory Group is led and coordinated by Bocconi University.  The External Advisory Group will be officially convened for a first kickoff meeting on November 15 at Bocconi University in Milan.

The recommendations for harmonising clinical and methodological criteria for the evaluation of digital medical devices resulting from these three work packages will be presented at the end of the first quarter of 2023 after feedback from the new expert committee, and then published as a consensus article.  The goal of the taskforce is to facilitate the accessibility of DMDs across the European Union, the recommendations will promote the creation of a joint HTA framework for DMDs across the EU in the framework of the European Regulation on Health Technology Assessment by 2025. The taskforce may also contribute to bi- and multilateral agreements of mutual recognition between agencies and ministries of health on collaboration and convergence of DMD assessment practices in the short to mid-term.

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