Know exactly what is missing from your technical documentation before your Notified Body does — written gap assessment report, severity ratings, and a prioritised remediation roadmap.
Submit your current certificate status below. Our Stockholm compliance team will review your application and respond within 2 hours to map which post-deadline transition pathways apply to your devices.
✓ Stockholm-Based Advisory Team
✓ GDPR-Compliant Data Routing
✓ Active Cross-Border Swiss (CH-REP) & EU Coverage
Searching for mdd to mdr gap analysis? Start with our downloadable checklist — Annex II/III, GSPR, and Notified Body readiness items in one place.
Download MDR Gap Analysis Checklist PDF →Our EU MDR gap assessment services compare your existing technical documentation against Regulation (EU) 2017/745 — Annex I (GSPR), Annex II, Annex III, and the conformity route for your device class. The output is a written report with every gap mapped to a specific MDR article, severity rating, and remediation priority.
Searching for eu mdr gap assessment services? This is the fastest path to Notified Body readiness — discover gaps before audit, not during it.
Expand each section to review what our gap assessment covers. Use this as a self-check before engaging NordMDR — or download the full PDF checklist.
We verify device description, intended purpose, variants, accessories, and classification rationale.
Every applicable GSPR must be addressed with evidence or justification for non-applicability.
Risk management file must be integrated with design and clinical evaluation.
Clinical evaluation report (CER) and post-market clinical follow-up plan per Annex XIV.
PMS plan, PSUR (where required), and vigilance procedures.
Information supplied by the manufacturer must meet Annex I Chapter III.
For devices requiring NB involvement, we assess submission readiness.
An EU MDR gap analysis compares your existing technical documentation against the mandatory requirements of Regulation (EU) 2017/745. The output is a written report identifying every gap and the specific corrective action needed — before you submit to a Notified Body.
Discovering gaps during a Notified Body audit is expensive and time-consuming. A gap analysis done first means no surprises, faster certification and lower overall cost.
We assess your documentation against Annex II (technical documentation) and Annex III (post-market surveillance technical documentation) of EU MDR 2017/745, including:
Step 1 — Document review. You share your existing technical file, clinical data, risk management file and quality documentation. We review against Annex II and III of EU MDR 2017/745.
Step 2 — Classification check. We verify your device classification under Annex VIII and confirm the correct conformity assessment route applies to your device class.
Step 3 — Gap identification. Every missing, incomplete or non-compliant element is documented against the specific MDR article or annex requirement it fails to satisfy.
Step 4 — Remediation roadmap. You receive a written report with a prioritised action list, effort estimates and clear guidance on what to do first to achieve compliance most efficiently.
Every gap analysis engagement includes a written Gap Analysis Report mapping every gap to the specific MDR requirement with severity rating, a prioritised Remediation Roadmap with effort estimates, written confirmation of device classification and conformity assessment route, a complete Annex II and III document status checklist, and a 30-minute debrief call to walk through findings.
You need an EU MDR gap analysis if your MDD CE certificate expires before December 2028 and you have not started MDR transition, a Notified Body has requested additional documentation, you are a non-EU manufacturer preparing to enter the European market for the first time, your clinical evaluation report has not been updated in more than 12 months, or you have made a significant change to your device and need to assess the impact on your technical file.
We will review your situation in a free 20-minute call and tell you whether a full gap analysis is the right next step — and what it will cost. No obligation.
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