Any actions as part of the proposal will be performed under the current regulatory framework and will not involve changing MDR/IVDR requirements. Proposals should present a major step towards digitalisation in Europe and Associated Countries. Governance of a potential IT infrastructure developed in Europe and Associated Countries is outside the scope of the topic.

The proposals should cover all the following points:

• all steps of the MDR/IVDR procedures, from manufacturer’s preparation of technical documentation and other pre-application activities for certification to issuance of a MDR/IVDR certificate by a NB;
• all actors involved in the conformity assessment procedure, including manufacturers, NBs, EU reference laboratories, expert panels of medical devices, as well as agencies involved in the consultation activities;
• a good representation of different NBs, including representation from small and large NBs, public and private NBs and a representative mix focusing on medical devices and in vitro diagnostic medical devices. The proposal should put a strong focus on consensus building activities between the different stakeholders involved.

The proposals should address all the following activities:

• Feasibility study
  • Review existing initiatives aimed at digitalising MDR/IVDR conformity assessment procedures, or part thereof, and investigate digitalisation of conformity assessment/approval procedures for devices in other jurisdictions (e.g., US Food and Drug Administration). Consider lessons learned from digitalising conformity assessment procedures in other areas than medical devices.
  • Examine basic processes/workflows established by individual NBs.
  • Identify main steps of the conformity assessment procedure to be digitalised, actors involved, and essential elements and requirements to be considered prior to digitalisation.
  • Collect and analyse feedback from main stakeholders on challenges and feasibility of the digitalisation process, identify interoperability with existing workflows used by manufacturers and/or NBs.
  • Determine technical specifications required for the digitalisation as well as the possible options regarding digital transformation platforms.
  • Analyse facilitating factors, main challenges, possible solutions and required resources.
• Pilot
  • Develop a pilot for the whole or part of the MDR/IVDR conformity assessment procedure, including Key Performance Indicators (KPI). This will involve collaboration with relevant stakeholders, including NBs, manufacturers, the European Commission and other involved parties.
  • Develop a dedicated platform to run the pilot or identify an existing platform suitable for the pilot.
• Roadmap towards digitalisation
  • Based on the lessons learned from the pilot, identify different steps to scale-up the pilot in order to digitalise MDR/IVDR conformity assessment procedures, or part of them. Identify associated challenges and possible solutions to address these.
  • Present a roadmap to the piloted approach, including possible alternatives, covering actors involved and resources needed.