For RA Managers Navigating
EU MDR for the First Time
18 templates covering CER, PMCF, PMS, technical documentation, and clinical evidence
You thought your MDD technical file was good enough. Then MDR hit.
Your notified body sends a 47-page gap analysis. Clinical evaluation report "does not adequately demonstrate equivalence." Post-market clinical follow-up plan "lacks sufficient detail." GSPR checklist "incomplete." State of the art analysis "outdated."
Your EU market access — the one generating 40% of your revenue — is suddenly at risk. The consultant quotes you €150,000 and 12 months to get compliant. Your product manager asks if you can "just skip Europe."
What if you had templates built specifically for what notified bodies actually review?
We mapped MDR requirements to NB audit patterns:
Every Annex requirement. Every MDCG guidance document. Every common audit finding from the top 10 notified bodies. We built templates that address the specific gaps NBs most frequently cite — with the specific language, structure, and evidence they're trained to look for.
These aren't generic EU regulatory templates. They're MDR-specific documents structured around Annex I GSPR requirements, Annex II/III technical documentation requirements, and MDCG guidance on clinical evaluation.
What's Included: 18 MDR Templates
Full MEDDEV 2.7/1 Rev 4 structure with MDR Annex XIV requirements.
Scope, methodology, literature search strategy, equivalence approach.
Post-market clinical follow-up activities per Annex XIV Part B.
Analysis and conclusions from PMCF activities.
Post-market surveillance system per Article 83-86.
Periodic safety update report structure per Annex III.
General safety and performance requirements matrix with evidence mapping.
Complete Annex II Section 4-6 structure and checklist.
Current knowledge analysis for your device category.
Technical, biological, clinical equivalence per MDCG 2020-5.
Structured analysis per Annex I Chapter I.
Systematic review methodology with PICO framework.
UDI-DI/UDI-PI assignment and database registration.
Article 11 requirements for non-EU manufacturers.
Structured response to NB audit observations.
EU MDR Compliance Toolkit
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The "NB-Ready" Guarantee
Use these templates for your MDR technical documentation. If your notified body raises a major finding for any documentation gap that should have been addressed by these templates, we'll refund your purchase in full.