Home › Services › Technical Documentation Audit
Technical Audit

EU MDR Technical Documentation Audit & Gap Analysis

Know exactly what needs fixing before your Notified Body sees it. We audit your complete technical file against EU MDR Annex II and III — and deliver a prioritised action plan in 1–4 weeks.

EU MDR Annex II / III UKCA Gap Analysis 1–4 Week Turnaround Pre-NB Submission
Request documentation audit → Full MDR certification
What you get
  • Detailed gap analysis report against MDR requirements
  • Severity-rated findings (Critical / Major / Minor)
  • Prioritised action plan with clear remediation steps
  • Compliance checklist mapped to MDR Annex II/III
  • 1-hour debrief call to walk through findings
  • Optional re-audit after remediation
Turnaround: 1–4 weeks from receiving documentation
Why audit before submission

The #1 reason Notified Body audits fail

Incomplete or non-compliant technical documentation is by far the most common cause of Notified Body audit delays and major non-conformities. An independent review before submission is the most effective risk mitigation available.

A Notified Body major non-conformity typically adds 3–6 months to your certification timeline and generates additional fees. Most of these non-conformities are predictable — and preventable with a pre-submission audit.

Most common critical findings we uncover

Critical
Clinical Evaluation Report doesn't meet MDCG 2020-1
CER written to MDD-era standards, missing systematic literature search protocol, or relying on equivalence without meeting MDR equivalence criteria.
Critical
Software documentation doesn't demonstrate IEC 62304 compliance
Generic reference to IEC 62304 without the evidence: no software classification justification, no architecture description, no V&V traceability matrix.
Major
Risk management file uses ISO 14971:2007 (not 2019)
Updated risk/benefit terminology and the requirement to demonstrate acceptable residual risk after controls are now expected by all major Notified Bodies.
Major
Post-market surveillance plan is generic
PMS plan that doesn't specify data sources, collection methods, analysis frequency, or thresholds for vigilance reporting will be returned by any competent NB reviewer.
Minor
Intended use statement is too broad
Vague intended use creates classification ambiguity and generates NB queries. Specific, well-defined intended purpose is the anchor of every compliant technical file.
When to get a documentation audit
  • 3–6 months before planned Notified Body submission
  • After inheriting documentation from a previous consultant
  • When transitioning from MDD to EU MDR technical file format
  • After acquiring a company with existing CE-marked products
  • Before responding to a Notified Body major non-conformity
  • When entering a new market (UKCA, Singapore HSA, TGA)
Audit scope
RegulationEU MDR / UKCA
Timeline1–4 weeks
DeliverableGap analysis + action plan
FormatRemote document review
Price rangeFrom €5,000

Send us your documentation and get an independent expert assessment.

Request documentation audit →
Audit scope

Every section of your technical file reviewed

We audit against the full EU MDR Annex II and III requirements — not just a checklist, but a substantive assessment of whether the content meets what Notified Bodies actually expect to see.

Technical Documentation (Annex II)

  • Device description & specification — intended use clarity, indications, contraindications, patient population, user profile, design variants
  • Design & development information — design stages, design outputs, change controls, architecture documentation
  • General safety & performance requirements (GSPR) — completeness of the GSPR checklist, justification of applicable requirements, evidence of conformity
  • Software documentation (IEC 62304) — software classification, architecture, development process evidence, V&V traceability
  • Risk management file (ISO 14971:2019) — risk management plan, risk analysis, evaluation, control, residual risk, benefit-risk assessment
  • Usability engineering (IEC 62366) — use specification, formative and summative evaluation, human factors documentation
  • Cybersecurity documentation — security risk management, vulnerability disclosure, patch management (MDCG 2019-16)
  • Labelling & Instructions for Use — compliance with MDR Annex I Section 23 and applicable labelling requirements

Post-Market Documentation (Annex III)

  • Clinical Evaluation Report (CER) — MDCG 2020-1 compliance, literature search methodology, clinical data sufficiency, benefit-risk conclusion
  • Post-Market Surveillance plan — specificity of data sources, feedback mechanisms, review frequency, trigger thresholds
  • Post-Market Clinical Follow-up plan — justification for no PMCF, or PMCF plan and methods if required
  • Periodic Safety Update Report template — PSUR structure, update frequency, mandatory content check
  • Summary of Safety & Clinical Performance (SSCP) — required for Class IIb+ implantable devices; format and content review

What the audit deliverable looks like

  • Section-by-section gap analysis — each MDR requirement rated: Compliant / Partially Compliant / Non-Compliant
  • Severity classification — Critical (NB major non-conformity), Major (NB query), Minor (improvement recommended)
  • Specific remediation guidance — not just "this is missing" but exactly what needs to be added or changed
  • Priority action plan — ranked list of what to fix first, with effort estimates
  • 1-hour debrief call — walkthrough of findings and Q&A with Lizaveta Dabrynskaya directly
FAQ

Technical documentation audit — common questions

What is a technical documentation audit for EU MDR? +
A technical documentation audit is a systematic, expert review of your existing medical device documentation against EU MDR Annex II and III requirements. The auditor checks each required section for completeness, accuracy, and regulatory compliance — identifying gaps, non-conformities, and areas needing improvement before your Notified Body review. The output is a detailed gap analysis report with severity-rated findings and a prioritised action plan.
When should I get a documentation audit? +
The ideal time is 3–6 months before your planned Notified Body submission. This gives you time to address critical gaps without delaying your certification timeline. An audit is also valuable after inheriting documentation from another consultant, after an M&A involving CE-marked products, or when you've received a major non-conformity from a Notified Body and need an independent assessment of what to fix.
What are the most common gaps found in EU MDR documentation? +
The top critical findings: (1) CERs that don't meet MDCG 2020-1 — missing literature search protocol or inadequate clinical evidence; (2) Risk management files using ISO 14971:2007 instead of 2019; (3) Software documentation that claims IEC 62304 compliance without traceability evidence; (4) PMS plans that are generic rather than product-specific; (5) Intended use statements that are too vague to support device classification. These five categories alone cover the majority of NB major non-conformities we see.
Do you also audit for UKCA and Asian market requirements? +
Yes. We audit against EU MDR, UKCA (UK MDR 2002 as amended), and can assess documentation against Singapore HSA and Australia TGA requirements. For companies seeking multiple market approvals, we identify which sections of your technical file satisfy multiple frameworks simultaneously and which require market-specific additions — avoiding duplication of effort in remediation.
Do you help with remediation after the audit? +
The documentation audit service covers the gap analysis and action plan — we do not write new documentation as part of this service. However, we can separately scope a follow-on engagement to address critical gaps, either as part of a full EU MDR certification project or as targeted document development for specific sections. Many clients use the audit to scope the remediation work and then engage us for a fixed-price remediation project.
→ Read our guide: How to choose a Notified Body for medical software certification
Related services

After the audit, what comes next

🇪🇺
EU MDR Full Certification
Audit found significant gaps? We take over the full certification workstream — from documentation remediation to CE mark.
🏗️
ISO 13485 QMS Implementation
If the audit reveals QMS gaps, we rebuild or improve your quality management system to meet ISO 13485 and MDR requirements.
📦
QMS Templates Package
Need to fill documentation gaps quickly? Our pre-built templates package covers 50+ controlled documents — ready to customise.

Know your gaps before the Notified Body does.

Send us your technical documentation and we'll deliver a comprehensive gap analysis in 1–4 weeks — before it costs you months of delays.

Request documentation audit →
From €5,000 · Fixed price · 1–4 week delivery