Evaluate your Preparedness for CE Marking
Is your technical documentation complete? Are you confident in your MDR readiness? Want to avoid costly delays and rejections?
Check your preparedness for CE Marking with Lumis’ free self-asssessment Scorecard ®!
This tool is for preliminary internal guidance only and does not replace formal regulatory assessment. Consult a qualified expert for CE-marking readiness validation.
-
What is it?
A tool for medical device manufacturers to self-assess their preparedness for CE-Marking planning process.
- 21 essential checkpoints across
- 5 key categories
- Scoring and automatic assessment scale
-
Why is it Helpful?
- Identify key compliance factors for the EU MDR
- Highlights items requiring attention
- Supports planning activities & saves time
-
How to use it?
- Fill in your scoring checkpoints
- View automatic scoring, color indicator, readiness status and final recommendation
- Use the output for internal alignment or contact Lumis for deeper expert advice
This tool is for preliminary internal guidance only and does not replace formal regulatory assessment. Consult a qualified expert for CE-marking readiness validation.