Compliance Assessment

EU MDR Transition

Assess EU MDR transition readiness.

$2,499one-time purchase

What this assessment evaluates

This assessment evaluates your eu mdr transition across 8 dimensions:

  1. Technical Documentation (Annex II/III)
  2. Clinical Evaluation & PMCF
  3. Post-Market Surveillance System
  4. UDI & EUDAMED Readiness
  5. Notified Body Relationship
  6. Labeling & IFU Updates
  7. Supply Chain & Economic Operator Obligations
  8. Transition Timeline Management

Who it's for

Regulatory and quality leaders managing the transition from MDD to EU MDR.

About this assessment

Evaluate your EU MDR transition across 8 dimensions.

What you get

Every assessment includes 8 integrated deliverables:

Excel

Assessment Framework

The scoring tool your team uses to evaluate each dimension.

Excel

Scoring Rubric

Level definitions and evidence criteria for every dimension.

Excel

Heatmap Template

Visual maturity snapshot — color-coded at a glance.

Excel

Delta Map Template

Current vs. target gap analysis for every dimension.

PDF

Methodology Guide

How to run the assessment — preparation, scoring, follow-up.

PDF

Benchmark Reference

Industry context for interpreting your scores.

PDF

Cross-Functional Team Guide

Who to involve and how to facilitate.

Word

Executive Readout Template

Present findings to leadership.

How it works

1

Purchase & download

Get your complete assessment package immediately after checkout.

2

Score with your team

Assemble your cross-functional team and score each dimension together.

3

Present & prioritize

Use the heatmap and executive readout to present findings and build your improvement roadmap.