DistillerSR joins €4M DIGICAP initiative to digitalize medical device certification

DistillerSR, a market leader in AI-enabled literature review automation and evidence management, has joined a €4 million European initiative, DIGICAP, aimed at transforming the traditional document-based conformity assessment process for medical devices and in vitro diagnostics (IVDs) into a more efficient, machine-readable system. The project, which is part of the Horizon Europe program, will see 19 organizations from 12 European Union countries collaborate to develop a digital framework for certification.

DistillerSR is one of five technology providers selected to contribute to this project, alongside Veeva, MEDDEVO, AUREVIA, and Hardian Health. The company will play a key role in the regulatory technology enablement layer, focusing on three main areas: co-design of the digitalization framework, input for feasibility studies, and pilot testing of digital tools.

Peter O'Blenis, CEO of DistillerSR, emphasized the importance of this initiative: "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."

Currently, conformity assessments under the EU Medical Device Regulation and In Vitro Diagnostic Regulation are predominantly document-centric, often taking up to 24 months to complete. DIGICAP aims to replace these document-based exchanges with machine-readable submissions, consensus APIs, and automated validation. This transition is expected to accelerate the review and approval process, ensuring that new medical technologies can reach European patients sooner and more safely.

The DIGICAP project, led by TEAM-NB, the European Association of Medical Device Notified Bodies, will deliver a consensus digitalization framework with a unified data model. This framework will be co-developed with notified bodies, manufacturers, and regulatory technology providers, and then evaluated with the wider stakeholder community. The project will also produce pilot digital tools, a public feasibility report, open-access training materials, and a scaling-up roadmap endorsed by TEAM-NB and MedTech Europe.

The consortium, which includes notified bodies, medical device manufacturers, IT and data standards experts, legal specialists, technology vendors, and public health organizations, will kick off its work in September 2026 in Malaga, Spain, and will run for three years.

DistillerSR has a proven track record in the industry, with more than 80% of the world's largest pharmaceutical and medical device companies relying on its platform for secure, transparent, and regulatory-compliant literature reviews. The company's involvement in DIGICAP is part of its ongoing commitment to advancing the digital transformation of medical device and IVD conformity assessments.

The goal of DIGICAP is to modernize the certification process, making it more efficient and patient-centric. By streamlining the assessment process and reducing the time to market for medical devices, the initiative aims to enhance patient safety and access to vital medical technologies.