The initiative aims to support the transition from document exchange to processes based on structured data. The project’s launch does not, in itself, introduce new regulatory obligations.
At a glance
- The timeline: DIGICAP began on September 1, 2026, and is scheduled to end on August 31, 2029.
- The coordination: the project is coordinated by Team-NB and brings together 19 European partners.
- The objective: to develop and test an open digital framework for conformity assessment under the MDR and IVDR.
- The funding: the European Union’s contribution through Horizon Europe amounts to approximately €4 million.
What is DIGICAP?
DIGICAP stands for DIGItalisation of the Conformity Assessment Process. The project addresses the digitalisation of conformity assessment procedures for medical devices and in vitro diagnostic medical devices.
The initiative comes against a backdrop of increasingly complex MDR and IVDR certification processes, which can make timelines, costs, and information exchanges difficult to manage and predict.
Team-NB’s announcement sets out a clear direction: moving from heavily document-based processes towards information management based on structured data and templates.
The consortium includes notified bodies, industry representatives, research organisations, and specialists in technology, law, regulatory affairs, and public health. The work also involves external contributors through a dedicated stakeholder engagement programme.
From documents to structured data
The central issue is how information is organised and exchanged.
A digital document may be readable by a person without its contents being directly usable by a computer system. Structured data, by contrast, is organised using shared fields and definitions that facilitate processing.
For example, placing information in a paragraph within a PDF and recording it in a defined field within a common template are two different ways of representing the same content.
DIGICAP aims to develop an open-source framework based on machine-readable data and standardised exchange formats. A vendor-neutral approach is envisaged, with the aim of avoiding dependence on a particular technology provider.
Interoperability is therefore central: the objective is to enable different tools to exchange and use information according to common rules.
How will the solutions be tested?
The project includes pilot activities involving manufacturers and notified bodies, covering medical devices, IVDs, and medical device software.
These pilots will test how the framework works in operational settings. Areas of interest include the completeness of submitted information, the handling of requests for additional information, and the efficiency of exchanges.
The results will inform a roadmap for potential wider implementation across Europe.
The expected benefits still need to be verified: the project’s objectives should not be confused with results already demonstrated.
What remains unchanged under the MDR and IVDR?
DIGICAP is presented as a project to develop and test digital tools. Its launch does not amend the MDR or IVDR, nor does it automatically make new documentation submission formats mandatory.
The distinction is between the requirements that must be met and the ways in which information is organised, transmitted, and reviewed.
The project addresses this second level. Digitalising information exchanges does not, in itself, change the criteria used to assess a device’s conformity.
Likewise, the scheduled end date of August 2029 marks the completion of project activities, rather than a general compliance deadline for manufacturers.
Why this development matters
DIGICAP focuses attention on a practical aspect of regulatory processes: the quality and compatibility of information exchanged between organisations.
The potential value of a common model lies in making data easier to read, verify, and reuse across different tools. The project links this ambition to the development of open specifications and testing with the organisations involved.
Three elements will be particularly relevant when assessing its progress:
- the specifications and data models that are published;
- the results of the pilot activities;
- the conditions identified in the roadmap for future adoption.
The announcement therefore marks the start of a move towards greater interoperability. Its practical impact will depend on the solutions developed, the results of testing, and the feasibility of adopting them in different operational settings.
Official sources
- Team-NB — EU project DIGICAP launch
- European Commission, CORDIS — DIGICAP, project no. 101288338
- DIGICAP — Official project website
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Informational note
This article is for informational purposes only and does not constitute regulatory, legal, technical, or professional advice. For applicable requirements and procedures, please refer to the official texts and current documentation issued by the competent authorities.