OTTAWA, ON / ACCESS Newswire / September 4, 2025 / DistillerSR, the market leader in AI-enabled literature review automation and evidence management, today launched new, expert-prepared EU-MDR workflow templates designed to reduce setup time and accelerate the completion of regulatory compliant literature reviews for notified body submissions. The comprehensive range of pre-built templates provide a ready-made framework for conducting literature reviews for State-of-the-Art (SOTA), Clinical Evaluation Reports (CERs), Summaries of Safety and Clinical Performance (SSCP), and post-market clinical follow-up (PMCF) studies. All templates are designed to leverage DistillerSR's AI-enabled workflows, reducing study completion time by up to 70%.
The EU-MDR requires medical device manufacturers to conduct and document rigorous reviews of clinical evidence to ensure their products meet safety and performance standards. By leveraging expert templates, medical device manufacturers can significantly reduce ramp up times and increase confidence in their evidence synthesis and reporting processes.
"Our goal is to empower manufacturers to move confidently through the EU-MDR process," said Peter O'Blenis, CEO at DistillerSR. "These expert workflows provide an actionable, fully compliant, pathway for evidence gathering, synthesis, and submission, accelerating the path to market for life-changing products."
DistillerSR's EU-MDR workflow templates provide ready-to-use workflows that follow notified body and EU regulatory requirements. These include:
Plug-and-Play Workflows: A complete framework for screening, data extraction, and quality assessment, optimized for EU-MDR requirements.
Standardized Fields: Pre-populated data extraction fields to capture all necessary evidence for PMCF, Periodic Safety Update Reports (PSUR), and Clinical Evaluation Reports (CER), among others.
Smart Evidence Extraction: Standard forms and questions that are AI-ready to rapidly suggest, extract and link evidence from scientific journals to answer closed and open-ended questions, including numerical content, sentiment analysis, risk of bias information, and study summaries.
Audit Trail: A comprehensive and defensible audit trail that automatically logs every step of the review process, simplifying audits, and regulatory submissions.
Robust Platform: A secure, cloud-based environment that has 99.999% uptime and allows teams to work together efficiently, regardless of location.
DistillerSR's EU-MDR packaged templates are the first of several planned industry-focused initiatives, with tailored HEOR, Health Technology Assessments (HTA), and Medical Affairs templates slated for later this year. The new EU-MDR templates are now available to all DistillerSR medical device customers.
DistillerSR is trusted by global research organizations, including more than 80% of the largest pharmaceutical and medical device companies, contract research organizations, governments, NGOs, and academic institutions.
Contact Information
Vivian MacAdden
Director, Industry Stakeholder Programs
vivian.macadden@distillersr.com
(613) 212-0051
SOURCE: DistillerSR Inc.
View the original press release on ACCESS Newswire:
https://www.accessnewswire.com/newsroom/en/healthcare-and-pharmaceutical/distillersr-unveils-ready-to-deploy-eu-mdr-literature-review-workflow-1068502
