White Paper
EU MDR Technical Documentation Remediation
A way through legacy device file remediation when the notified body review date is already in the diary.
Overview
Legacy technical files written under the MDD rarely survive first contact with an MDR review. Clinical evaluation is thin. Post-market surveillance is retrospective. The safety and performance requirements matrix was assembled once, years ago, and never opened again.
The paper breaks remediation into work packages that can run in parallel across a portfolio, with guidance on the triage question everyone gets stuck on: which device families need a full rewrite, and which just need targeted evidence. Teams who have already had a deficiency letter tend to skip to the sequencing section.
What you will learn
- Triage a device portfolio by remediation effort against commercial priority
- Write a clinical evaluation report that answers the deficiency findings that recur
- Rebuild the GSPR matrix so it traces cleanly back to objective evidence
- Close post-market surveillance gaps without restarting the file
- Scope the specialist support a remediation really needs
How Viltis helps
Related services
The practices in this paper map to work our consultants deliver directly. If you would rather have it done than read about it, start here.
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