Why an internal review pays off
The cheapest place to find a gap in technical documentation is inside your own company. Every gap found by FDA or a notified body costs weeks: a hold, a deficiency letter, another review round.
The European numbers are stark. Team-NB’s latest survey, as reported by RAPS, found that “65% of submitted MDR files lack at least half of the required information,” while “MDR and IVDR reviews typically take between 13 and 18 months” (RAPS). A notified body “must receive a complete technical review document before it can begin its review.”
For EU MDR Annex II and III in detail, see EU MDR Technical Documentation: Annex II and III Explained, With Common Notified Body Findings.
What “technical documentation” means in each market
| Market | What it is called | Format | Review |
|---|---|---|---|
| US (510(k), De Novo) | Premarket submission, supported by the design and development file | eSTAR, mandatory for 510(k) since October 2023 and for De Novo since October 1, 2025 (Complizen) | FDA technical screening, then substantive review |
| EU (MDR) | Technical documentation (Annexes II and III) | Manufacturer’s own structure | Notified body assessment for most classes |
FDA states that “eSTAR submissions are not anticipated to undergo a Refuse to Accept (RTA) process”; instead, FDA “intends to employ a virus scanning and technical screening process” (FDA, eSTAR program). The current non-IVD and IVD templates are version 7.1. eSTAR enforces completeness of fields, not quality of content; a filled field can still be wrong.
Why technical files fail review
Notified body DQS, drawing on Team-NB guidance, lists three recurring causes of delay (DQS):
- Information: “Insufficient, inconsistent or missing information necessary for complete conformity assessment activities.”
- Structure: “While the information is present, it is difficult to locate within the technical documentation.”
- Scope: “The submission scope is too broad for a single conformity assessment.”
In the US, the same root problems show up as additional-information requests and, later, as inspection findings when the design file does not support what the submission said.
What an internal technical documentation review should check
| Area | Questions to ask |
|---|---|
| Device description and intended use | Is the intended use worded the same way in every document, label and IFU? |
| Classification and pathway | Is the rationale current, including software functions? |
| Design and verification | Does every claim in the summary trace to a verification report with criteria and results? |
| Validation and human factors | Is the HF submission category justified? Is clinical evidence sufficient for the claims? |
| Risk management | Do hazards, controls and residual risks match the design file and labeling? |
| Software and cybersecurity | Does documentation match the software documentation level and include testing evidence? |
| Biocompatibility, sterilization, shelf life | Are test reports current for the final materials and processes? |
| Labeling | Do claims match evidence, and are warnings tied to residual risks? |
| Post-market (EU) | Are the PMS plan, PSUR or PMS report and clinical evaluation consistent? |
| Consistency | Are names, model numbers, versions and dates the same across documents? |
How to run the review
- Freeze a version. Review a controlled snapshot, not a moving target.
- Map to the template. Use eSTAR sections or Annex II and III as the checklist backbone.
- Assign independent reviewers for each area, not the original authors.
- Read across documents, not just within them. Most findings are inconsistencies.
- Trace claims to evidence: every performance claim to a report and page.
- Log findings by severity with the document, section and required fix.
- Close and re-check before submission; keep the review record in the design file.
Trends to plan for in 2026
- eSTAR is the only door for 510(k) and De Novo, and FDA updates templates regularly; version 7.1 is current (FDA).
- More evidence held, not submitted. FDA’s May 2026 final human factors content guidance lets some submitters justify not sending HF validation data, but recommends keeping it “regardless of whether it is submitted” (FDA Law Blog). The design file must back every justification.
- EU capacity is growing, slowly. Certificate issuance rose 45% in 2025, from 11,292 to 16,453, after doubling in earlier years (RAPS). Complete files move first.
- QMSR links submission and inspection. Since February 2, 2026, inspectors evaluate design records under ISO 13485 clause 7.3; claims in a submission must match the design file (FDA).
Technical documentation review checklist
- Controlled snapshot of all documents under review
- Intended use identical across documents, labels and IFU
- Every performance claim traced to a report with criteria and results
- Risk file, design file and labeling consistent
- Software documentation level and evidence aligned with FDA guidance
- HF category and rationale documented
- Test reports current for final design, materials and processes
- Names, models, versions and dates consistent
- eSTAR sections or MDR Annex II and III fully covered
- Findings logged, closed and re-checked before submission
Review the whole file, not just each document
The findings that cost the most are inconsistencies between documents. AskDona reads a technical file as a set, checks it against eSTAR sections, MDR Annexes II and III or your own checklist, flags missing evidence, contradictions and untraced claims, and cites the passage behind every finding.
Run a sample technical file review on one submission package. AskDona shows the evidence; your regulatory team decides.
FAQ
What is medical device technical documentation? The evidence that a device meets regulatory requirements: description, design, verification, validation, risk, labeling and, in the EU, post-market documents.
What is a technical file review? An internal or external check that technical documentation is complete, consistent and supported by evidence before or during regulatory review.
Is eSTAR mandatory? Yes, for 510(k) and De Novo submissions unless exempted (FDA).
How long does notified body review take? MDR and IVDR reviews typically take 13 to 18 months, per Team-NB as reported by RAPS (RAPS).
What causes most technical file delays? Missing or inconsistent information, poor structure and overly broad scope (DQS).
References
All pages opened and checked by October 14, 2026.
| Source | Type | Date | Used for |
|---|---|---|---|
| RAPS: Team-NB survey | Professional body | May 28, 2026 | Incomplete files, review times |
| FDA: eSTAR program | Regulator | Sep 21, 2026 | Mandatory use, technical screening, v7.1 |
| Complizen: eSTAR after Oct 1, 2025 | Vendor | May 16, 2026 | Mandatory dates |
| DQS: Common technical documentation mistakes | Notified body | Feb 21, 2025 | Delay causes |
| FDA Law Blog: Final HF content guidance | Law firm blog | Jun 3, 2026 | HF data retention |
| FDA: QMSR risk-based inspections (slides) | Regulator | Apr 1, 2026 | Design elements inspected |