WhitepaperNovember 14, 2025
Navigating MDR tender requirements
MA
Matteo AlbonicoWhitepaper
The EU Medical Device Regulation has fundamentally changed what public procurement authorities expect from medical device manufacturers in tender submissions. New documentation standards, UDI requirements, and conformity obligations have added layers of complexity that most tender teams were not built to handle — and the margin for error is shrinking.
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What you'll learn
- How MDR has changed technical documentation requirements in European public tenders
- The impact of UDI compliance on tender eligibility and submission completeness
- Where most medical device companies are falling short in MDR-compliant tender responses
- How to align your regulatory and tender management workflows to reduce compliance risk
- The role of Document Intelligence in managing MDR documentation at scale