This funding opportunity supports projects aimed at digitalising the conformity assessment procedures under the Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR). The goal is to enhance the efficiency, transparency, and predictability of these procedures, benefiting manufacturers (especially SMEs), Notified Bodies (NBs), and regulatory authorities. Ultimately, the initiative aims to maintain an innovative, sustainable, and competitive EU health industry.

Expected Outcomes:

• Adoption of digital tools by NBs, device developers, and manufacturers, facilitating device development and regulatory consultations.

• More efficient, less burdensome, and predictable conformity assessment processes, reducing costs and time-to-market.

• Increased capacity of manufacturers, particularly SMEs, to focus resources on innovation and R&D.

Scope:

• The MDR and IVDR impose strict regulatory requirements to ensure patient safety and public health, but implementing these remains challenging, especially for SMEs.

• Currently, conformity assessments rely on complex electronic document exchanges (e.g., PDFs, Excel), requiring multiple iterations between stakeholders.

• Digitalising these processes—from document-centric to data-driven workflows—can improve accuracy, reduce administrative burdens, shorten certification timelines, and harmonize assessments across Europe.

• Proposals should operate within existing MDR/IVDR regulations without altering their requirements.

• Governance of IT infrastructure is outside the call’s scope.

Proposals Must Address:

• The full spectrum of MDR/IVDR procedures from manufacturer documentation preparation through certificate issuance by NBs.

• Inclusion of all relevant stakeholders: manufacturers, NBs (small/large, public/private), EU reference labs, expert panels, and consulting agencies.

• Focus on consensus-building among diverse stakeholders.

Main Activities to Be Undertaken:

1. Feasibility Study:

   • Review existing digitalisation efforts in MDR/IVDR and other jurisdictions (e.g., FDA).

   • Analyze workflows of NBs and identify key digitalisation targets.

   • Gather stakeholder feedback, assess interoperability with existing systems.

   • Define technical specifications, challenges, enabling factors, and resource needs.

2. Pilot:

   • Develop and run a pilot for part or all of the conformity assessment process.

   • Collaborate closely with NBs, manufacturers, European Commission, and others.

   • Develop or select a suitable digital platform.

   • Define and monitor Key Performance Indicators (KPIs).

3. Roadmap Development:

   • Use pilot insights to plan scale-up steps for digitalisation.

   • Identify challenges and solutions for broader implementation.

   • Outline actors, resources, and alternative approaches in a clear roadmap.