A gap analysis is the fastest way to understand where your technical documentation stands against EU MDR requirements — and what it will cost to close the gaps. We deliver a clear, actionable roadmap in writing.
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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