Digitalising the EU medical device certification process: EU-funded DIGICAP project launches to digitalise and streamline Conformity Assessment Procedures
BRUSSELS, 1 September 2026 — Today marks the official launch of DIGICAP (DIGItalisation of the Conformity Assessment Process), a 3 year, €4M initiative funded by the European Union’s Horizon Europe programme (Grant Agreement No. 101288338).
Coordinated by Team-NB (the European Association of Medical Devices Notified Bodies), DIGICAP brings together 19 leading European partners to address critical bottlenecks in medical device and in vitro diagnostic certification across Europe.
Addressing the certification bottleneck
The implementation of the EU Medical Device Regulation (MDR 2017/745) and In Vitro Diagnostic Medical Devices Regulation (IVDR 2017/746) has significantly enhanced patient safety standards. However, it has also introduced complex administrative demands that have doubled average certification times to 13–18 months. Current procedures remain heavily document-centric, relying on manual exchanges of unstructured PDF and Excel files between manufacturers and Notified Bodies. This complexity often leads to incomplete submissions, unpredictable certification timelines, and market delays—disproportionately impacting Small and Medium-sized Enterprises (SMEs) and delaying patient access to life-saving technologies in the EU.
A data-driven, open-source vision
DIGICAP aims to catalyze a paradigm shift by moving from document-based submissions to a harmonised, machine-readable, and interoperable digital framework.
Key pillars of the DIGICAP project include:
• Standardised canonical data architecture: Developing open-source data schemas (JSON-LD / JSON Schema) and unified ontologies aligned with MDR/IVDR requirements to enable seamless data exchange across systems.
• Vendor-neutral interoperability: Establishing standardized APIs (OpenAPI/MCP) that integrate with existing electronic Quality Management Systems (eQMS) and Regulatory Information Management tools, avoiding vendor lock-in and fostering fair market innovation.
• Human-in-the-loop AI and automation: Exploring recommendations and safeguards for integrating Human-in-the-Loop AI tools to accelerate documentation preparation and automated pre-submission completeness checks.
• Real-world pilot demonstrations: Conducting controlled, side-by-side pilot tests with Notified Bodies and medical technology manufacturers (at least 80% SMEs) across medical devices, IVDs, and Software as a Medical Device (SaMD).
• A scalable EU implementation roadmap: Delivering a consensus-backed strategic roadmap for scaling digital conformity assessments across all EU Member States.
Executive vision: Predictability and patient safety
“The launch of DIGICAP is highly anticipated and pivotal for European healthcare innovation,” states Françoise Schlemmer, Project Coordinator and Director of TEAM-NB (The European Association of Medical devices Notified Bodies). “Our mission is built upon three non-negotiable pillars: maximizing regulatory efficiency, providing manufacturers with long-term predictability, and—most importantly—reinforcing patient safety through transparent, rigorous data validation.”
As the coordinator representing the Notified Bodies, TEAM-NB ensures that DIGICAP’s technical outputs directly address the real-world bottlenecks of the Medical Device Regulation (MDR). By aligning technical modernization with the high-level objectives of EU health policy, Schlemmer’s leadership vision transforms compliance from a hurdle into a catalyst for medical excellence. Translating this vision into operational reality requires a multidisciplinary assembly of Europe’s leading MedTech and legal authorities.
"For years, manufacturers and Notified Bodies alike have been trying to manage twenty-first century medical technology through twentieth century paperwork," said Petra Zoellner, Director of Regulatory Affairs (IVDR & MDR) at MedTech Europe. "DIGICAP is about replacing that friction with structure—giving industry, and especially the SMEs that make up the backbone of our sector, a predictable, machine-readable path to certification. If we get this right, we don't just speed up compliance; we free up resources for innovation and, ultimately, get safe technologies to patients faster." As the voice of the medical technology industry in the consortium, MedTech Europe brings the perspective of manufacturers into the design of DIGICAP's data schemas and interoperability standards. With four in five pilot participants drawn from smaller manufacturers, the project is structured to test its tools against the realities SMEs face under MDR and IVDR, from limited regulatory-affairs resources to unpredictable certification timelines. Working alongside Notified Bodies, research institutes, and legal experts, MedTech Europe helps ensure that the resulting framework is not only technically sound but genuinely usable across the diversity of Europe's medtech sector.
Pan-European Collaboration
The DIGICAP consortium spans 10 EU Member States and brings together an unprecedented cross-section of regulatory, industry, and technical expertise:
• 11 Notified Bodies (both public and private, large and small).
• Industry and data model experts: MedTech Europe and the Medical Device Knowledge Units (MDKU) foundation.
• Technical and scientific research institutes: RISE (hosting the EURL for IVDs) and VITO (technical coordination).
• Legal, management and public health experts: AXON Lawyers, Matical Innovation, and the European Public Health Association (EUPHA).
Get involved: Stakeholder Engagement Programme
To ensure the framework aligns with real-world needs, DIGICAP will run an active Stakeholder Engagement Programme (SEP). Representatives from medical technology enterprises, software vendors, regional competent authorities, and healthcare experts are invited to participate in open consensus workshops and Delphi review cycles throughout the project lifecycle.
To learn more about DIGICAP, follow project updates, or participate in upcoming stakeholder activities, visit our official project website and follow our LinkedIn page.
Project details
• Project title: DIGICAP – DIGItalisation of the Conformity Assessment Process
• Grant Agreement: No. 101288338 (Horizon Europe - HORIZON-HLTH-2025-01-IND-02)
• Type of action: HORIZON-CSA - HORIZON Coordination and Support Actions
• Start and end date: 1 September 2026 – 31 August 2029 (Duration: 36 months)
• Project coordinator: Team-NB (European Association Medical Devices - Notified Bodies)
• Website
This project has received funding from the European Union’s Horizon Europe research and innovation programme under grant agreement No 101288338. Views and opinions expressed are however those of the author(s) only and do not necessarily reflect those of the European Union or HaDEA. Neither the European Union nor the granting authority can be held responsible for them.