MDD to MDR Gap Analysis — Know Exactly What's Missing Before Your Notified Body Does
Transitioning from the Medical Device Directive to EU MDR 2017/745 is not just an update — it's a complete overhaul of how your Technical Documentation needs to be structured, evidenced, and maintained.
Most companies don't discover their gaps until they're already in front of a Notified Body. That's expensive. That's avoidable.
The MDD to MDR Gap Analysis is a professional Excel tool that maps every critical difference between Directive 93/42/EEC and Regulation (EU) 2017/745 — so your team knows exactly what needs to be done, in what order, and who owns it.
What's inside:
19 documented gaps across 9 regulatory areas — including Clinical Evaluation, Post-Market Surveillance, Technical Documentation, Labelling, UDI, EUDAMED, Software, Risk Management, and Notified Body certification.
Every gap is classified by severity — Major Gap, Minor Gap, or New Requirement — with color coding so you can prioritize at a glance.
Each row includes the exact MDD requirement, the MDR equivalent, and a clear explanation of what changed and why it matters for your submission.
Built-in dropdowns for Status, Priority, and Owner so your team can assign accountability and track progress in real time.
A live Summary Panel that auto-calculates how many gaps are open, closed, and critical — no manual counting needed.
MDD to MDR Gap Analysis — Know Exactly What's Missing Before Your Notified Body Does
Transitioning from the Medical Device Directive to EU MDR 2017/745 is not just an update — it's a complete overhaul of how your Technical Documentation needs to be structured, evidenced, and maintained.
Most companies don't discover their gaps until they're already in front of a Notified Body. That's expensive. That's avoidable.
The MDD to MDR Gap Analysis is a professional Excel tool that maps every critical difference between Directive 93/42/EEC and Regulation (EU) 2017/745 — so your team knows exactly what needs to be done, in what order, and who owns it.
What's inside:
19 documented gaps across 9 regulatory areas — including Clinical Evaluation, Post-Market Surveillance, Technical Documentation, Labelling, UDI, EUDAMED, Software, Risk Management, and Notified Body certification.
Every gap is classified by severity — Major Gap, Minor Gap, or New Requirement — with color coding so you can prioritize at a glance.
Each row includes the exact MDD requirement, the MDR equivalent, and a clear explanation of what changed and why it matters for your submission.
Built-in dropdowns for Status, Priority, and Owner so your team can assign accountability and track progress in real time.
A live Summary Panel that auto-calculates how many gaps are open, closed, and critical — no manual counting needed.
