EU MDR compliance support for a Gastrointestinal Reflux Monitoring Device Manufacturer
Strategic Regulatory Consulting for Ancillary Medicinal Substances and Clinical Evidence
Project Summary
A medical device/combination product manufacturer partnered with Celegence for expert regulatory consulting to support EU MDR compliance. The engagement focused on a product incorporating an ancillary medicinal substance (PHMB coating), where regulatory and clinical evidence challenges created uncertainty about the product’s future under MDR.
Celegence provided regulatory GAP analysis and strategic recommendations, assessing the client’s product portfolio against EU MDR expectations and delivering actionable insights for decision-making.
Celegence Solution & Approach:
Celegence supported the client with:
Highlights:
Conducting a regulatory GAP analysis for the medicinal substance component (PHMB coating)
Reviewing baseline clinical documentation: Intended Purpose, SOTA, PSURs, and similarity justifications
Assessing data against EU MDR and MDCG guidance to identify minimum data requirements and blockers
Delivering a checklist and report analyzing open sections of 3.2.S/P, GMP considerations, and technical documentation readiness
Developing a comprehensive strategy document, including conformity pathway recommendations (per MDCG-2023-7)
Creating a roadmap for addressing gaps and strengthening regulatory compliance
Project Achievements
The client gained clarity on regulatory expectations and potential risks related to ancillary medicinal substances. Celegence’s expertise enabled the client to:
Identify compliance gaps and data needs early
Strategically plan the future of their product portfolio
Make an informed, evidence-based decision on product continuation
Align clinical evidence and documentation with MDR and MDCG guidance
Project Success
Close collaboration between Celegence experts and the client team ensured that tailored, strategic insights were delivered quickly and effectively. By combining regulatory know-how with structured analysis, the engagement provided the client with both immediate guidance and a long-term roadmap for MDR compliance..
Need EU MDR-Compliant Strategies for Combination Products?
Celegence delivers expert regulatory consulting, GAP analysis, and strategic recommendations for ancillary medicinal substances and clinical evidence - helping you plan with confidence.
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22 Aug, 2025
08 Aug, 2025
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