Towards a common evaluation framework for digital medical devices in the European Union - Launch of a European taskforce

Regulations

26/10/2022

The aim of the European taskforce is to reach a consensus between agencies competent for health technology assessment at national level, in order to harmonize assessment criteria for digital medical devices (DMDs) in the European Union (EU). The results of these three working groups ("work packages") were presented at the "Digital Medicine" Conference in Luxembourg on October 26 and 27.

The taskforce is chaired by the French Ministry of Health's Délégation ministérielle au numérique en santé, co-chaired by the European Network for Health Technology Assessment (EUnetHTA) and coordinated by EIT Health. The rapporteur is the University of Luxembourg. The taskforce brings together academic experts in the field as well as representatives of health technology assessment (HTA) agencies from a dozen European countries, including Germany, France, Luxembourg, Finland, Belgium, Denmark, Austria and Spain.

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France and Germany, two major countries with recently established or forthcoming accelerated procedures for MND reimbursement, were involved at the heart of the taskforce. Both countries have developed new HTA procedures linking the different definitions of DMNs to the generation of evidence needed to test their clinical efficacy. In France, in addition to DNS, representatives from the Haute Autorité de santé (HAS), the Institut national de la santé et de la recherche médicale (Inserm), the Institut national de recherche en sciences et technologies du numérique (Inria) and the Université Paris Cité (UPCité) are leading part of the work. For Germany, the Federal Institute for Drugs and Medical Devices (BfArM), which is responsible for the fast-track procedure for digital health applications in Germany (DiGA), is actively involved in the project.

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The taskforce's three "work packages" have already begun their work, and are focusing in particular on the following themes:

  • The proposal for a harmonized taxonomy for the different types of MND according to their scope
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  • The production of recommendations for harmonizing the clinical requirements for assessing MNDs while respecting the mandates of national authorities with a questionnaire currently being administered to the HTA agencies of the 27 member states
  • The proposal of an evaluation framework to include in particular the socio-economic dimension of DMNs as part of their integration into healthcare systems

In order to accompany and illustrate the work of the taskforce, but also to test the recommendations, a committee of experts was set up for the taskforce following a call for applications, supervised by Bocconi University in Milan. The role of this committee of experts will be to evaluate the work of the taskforce, to provide concrete case studies, and to support and disseminate the taskforce's work. The expert committee will be officially convened for a first kickoff meeting on November 15 at Bocconi University in Milan.

The recommendations for harmonizing the clinical and methodological criteria for evaluating DMNs resulting from these three work packages will be presented at the end of the first quarter of 2023, after validation by the new expert committee, and then published as a consensus article. As the taskforce's objective is to facilitate the accessibility of MNDs within the EU, the recommendations will foster the creation of a common framework of MND assessment criteria in line with the European regulation on health technology assessment by 2025. The taskforce could also give impetus to bi- and multilateral mutual recognition agreements between agencies and ministries of health on collaboration and convergence of MND assessment practices in the short and medium term.