France, Digital Medical Devices Taskforce, France

EIT Health Matchmaking Luxembourg : Launch of a Taskforce on Digital Medical Devices

4th November 2022

The EIT Health Matchmaking event for the flagship “Facilitating the Uptake of Digital Medical Devices in Europe” hosted jointly with the European Digital Medicine Conference has successfully commenced from 25-27 October 2022 in Luxembourg.

Focusing on the development of and access to digital health medical devices, the flagship “Facilitating the uptake of digital medical devices in Europe” aims to support digital health transformation across countries. The matchmaking event offered meaningful networking opportunities to support innovative partnerships and sparked conversations between EIT Health partners and beyond.

After an introduction of the Flagships by Cristina Bescos, Director of Innovation and Magda Krakowiak, Head of Open Innovation, Prof. Dr. Jochen Klucken, Chair of Digital Medicine at University of Luxembourg explored the meaning of “real market access” in case of digital medical devices, arguing that the added value of digital technologies does not solely rely on market access, but on patient and physician access. The keynote has outlined the necessity of assessment and financing procedures after the MDR  & CE-mark regulatory steps for digital medical devices to reach their full potential. 

Sessions have explored the regulatory background and current status of health technology assessment procedures for digital technologies, while start-ups and technology developers have shared their practical experience and guidance for implementation across Europe, setting out the European landscape and highlighting the opportunities and hurdles for broader adoption of digital medical devices across Europe. 

Partners were urged to explore how to transform, harmonise and strengthen the use of digital medical devices by looking at:

1) The prescription and reimbursement in EU countries for already certified medical devices

2) The harmonisation of clinical trial protocol design to ensure the replicability and consistency of medical outcomes between member states for faster reimbursement.

Inspiring outcomes of the discussions have been wrapped up, put on paper and pursued further when it comes to project planning and implementation to support the digital health transformation across Europe.

After insights from France, Germany and Finland on their respective, innovative assessment processes for digital health solutions, the chair, co-chair and rapporteur of the Taskforce have presented the objectives, progress and the three work packages working on recommendations for a joint, pan-European assessment procedure:

1) The first propositions to harmonise the taxonomy for different types of DMDs according to their scope of application,

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, and

3) a proposition of an evaluation framework for the socio-economic dimension of DMDs in the context of their integration into health systems.

To arrive at robust, real-world-ready recommendations, an external advisory group was set up to incorporate the input of relevant stakeholders of the European DMD ecosystem in the recommendations of the Taskforce. The 15 members recently selected to join the Advisory Group have been announced by Rosanna Tarriocone, lead of the Advisory Group, after a thorough selection process through an Open Call for Applications.

The exchange among representatives of Luxembourg NHIF, Ministry of Health, Ministry of Economy and representatives of the DMD Taskforce has been centred around the challenges Luxembourg faces in integrating digital medical devices into their healthcare system and how the Taskforce can support Member States in moving towards assessment and reimbursement of digital technologies.

Agreement was found that Digital medical devices (DMDs) are subject to clinical evidence-based requirements and reach a new level of regulatory challenges linked to market access and reimbursement of digital supported patient care and caregiver management at community medicine and hospitals. Overcoming those challenges and addressing specificities of digital health technologies regarding clinical evidence generation, regulatory assessment and reimbursement procedures is of prime importance to facilitate patient access.

This is just a snapshot of some of the valuable ideas shared at the DIgital Medical Device conference organised jointly with the EIT Health matchmaking in Luxembourg, which brought together leaders in academia, industry, medicine, patient organisations and influential policymakers.


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