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DistillerSR Joins European MedTech Consortium to Digitalize Medical Device and IVD Conformity Assessments
DistillerSR Joins European MedTech Consortium to Digitalize Medical Device and IVD Conformity Assessments
€4 million European-funded DIGICAP project brings together 19 organizations to replace document-based conformity assessments with machine-readable data. DistillerSR named one of five technology providers building the framework.
OTTAWA, ON / ACCESS Newswire / September 3, 2026 / DistillerSR, the market leader in AI-enabled literature review automation and evidence management, today announced its participation in DIGICAP (DIGItalisation of the Conformity Assessment Process), a €4 million European initiative uniting 19 organizations across 12 EU countries to digitalize how medical devices and in vitro diagnostics are certified for the European market. The project is funded under Horizon Europe, the world's largest multinational research and innovation program, with a budget of €95.5 billion for the 2021-2027 period.
DistillerSR is one of five regulatory technology providers selected to support the project, alongside Veeva, MEDDEVO, AUREVIA and Hardian Health. The company will work in the regulatory technology enablement layer and will contribute across three areas:
Co-design of the digitalization framework. Informing the consensus framework, unified data model and API specifications from the perspective of a production evidence management platform already operating inside regulatory and clinical affairs teams.
Feasibility study input. Contributing to the analysis of notified body and manufacturer needs that will define the project's technical specifications and baseline metrics.
Pilot testing. Named as a target user for the project's digital tools, trialling early minimum viable prototypes and feeding real usage data back before the framework is finalized.
"The move from document submission to the electronic submission of structured data has obvious and important benefits in terms of rigour, cost, and time. Ultimately, this will help drive faster, safer access to important medical products for patients," said Peter O'Blenis, CEO of DistillerSR. "We are pleased to bring our experience and expertise in the regulatory application of evidence to this important initiative and look forward to contributing to an improved digital regulatory framework."
Conformity assessments under the EU Medical Device Regulation and In Vitro Diagnostic Regulation remain a largely document-centric process, often taking up to 24 months to complete. DIGICAP's mission is to replace document-based exchanges with machine-readable submissions, consensus APIs and automated validation, advancing toward semi-automated notified body review and lifecycle surveillance so that new medical technologies reach European patients sooner and safely.
About DIGICAP
The DIGICAP project will deliver a consensus digitalization framework with a unified data model, co-developed with notified bodies, manufacturers and regulatory technology providers, then evaluated with the wider stakeholder community. Its schemas, APIs and ontologies will be published under open-source licences so that conformity assessment tools can interoperate. Alongside the framework, DIGICAP will produce pilot digital tools released as reference implementations, a public feasibility report, open-access training materials, and a scaling-up roadmap endorsed by TEAM-NB and MedTech Europe.
The consortium is led by TEAM-NB, the European Association of Medical Device Notified Bodies, and brings together notified bodies, medical device manufacturers represented by MedTech Europe, IT and data standards experts, legal specialists, technology vendors and public health organizations. The project kicks off in September 2026 in Malaga, Spain, and will run for three years.
About DistillerSR
DistillerSR is the pioneer and market leader in AI-enabled literature review automation and evidence management. Today, more than 80% of the world's largest pharmaceutical and medical device companies trust DistillerSR to securely produce transparent, audit-ready and regulatory-compliant literature reviews. The DistillerSR platform and modular ecosystem enable customers to securely automate the management and analysis of evidence-based research - faster, more accurately, more transparently, and at scale.
For more information, visit www.distillersr.com.
DistillerSR Inc. Media Contact: Vivian MacAdden [email protected]
SOURCE: DistillerSR Inc.
View the original press release on ACCESS Newswire
F. Burkhard--BTZ
