EU MDR technical documentation review that finds the gap and the contradiction before the notified body does
Technical files that pass notified body review the first time, every requirement cited.
See one case, screen by screen ↓It is the check, before submission to a notified body, that the Annex II technical documentation proves the device meets every applicable General Safety and Performance Requirement in Annex I of Regulation (EU) 2017/745. EU MDR Technical Documentation Review does it with five agents that map each GSPR line to the document, revision and page that meets it, check standard editions and cross-read facts between documents, for a regulatory lead to decide and sign.
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A class III technical file is close to two hundred documents and thousands of pages: the device description and specification, label artwork and IFU, design and manufacturing information, the GSPR checklist, the risk management file, bench, biocompatibility, sterilisation and aging reports, and the clinical evaluation. Before submission a regulatory affairs lead walks the GSPR checklist line by line in a spreadsheet, looking for the document and page that meets each Annex I requirement — about six weeks per file for one reviewer.
What the notified body finds is what nobody had time to cross-read. A shelf life extended by change control in the design file but never on the label. An IFU chart copied from a sister device's template. A UDI-DI with two digits swapped in the draft Declaration of Conformity. A biological evaluation still on a superseded edition of EN ISO 10993-1. A line marked “not applicable” with no reason. Each one can mean another round of questions, and legacy devices must hold an MDR certificate by 31 Dec 2027 or 2028 while notified bodies most often take 13–18 months to certify.
Estimated split for one class III technical file reviewed before submission, by hand and with the solution.
Five specialist agents index, map, check and cross-read every technical file; a regulatory lead decides and signs.
Corvane Medical must move Calvera NC, a class III coronary dilatation catheter with a non-compliant balloon, from its legacy MDD certificate to an MDR certificate by 31 Dec 2027. Submission to the notified body is planned for 30 Nov 2026. Here is the pre-submission review, screen by screen, in the working solution.
Ingrid opens the GSPR board for Calvera NC: one ring per Annex I section, grouped by chapter. The file stands at 86% — 88 of 102 applicable lines evidenced, 11 gaps, 3 contradictions, and 79 lines not applicable, each with a reason. Section 23, label and instructions for use, sits at 80%, 32 of 40 lines, with two red notches.
“Labels and IFU drew 22 of the 61 questions the notified body asked about Calvera SC in 2025 — including shelf life (Q14) and the symbols standard (Q9).”
The file came from the document control system on 9 Oct 2026: 186 documents, 9,412 pages. The file indexer sorts them into the six sections of Annex II and sets 14 superseded revisions aside, never cited. The GSPR mapper sorts 181 checklist lines into 102 applicable and 79 not applicable, then finds evidence for 88. The standards checker compares 24 standards, the consistency checker reads 8 facts in 46 places, and the review report writer drafts the report.
4 h 12 min of agent time — every step shown with what it found.
The biological evaluation report BER-019 follows ISO 10993-1:2009; the current edition is EN ISO 10993-1:2020. The line becomes gap G-03, with a suggested fix — update the biological evaluation plan and report to the 2020 edition, or justify — owned by Mateo Lindgren, due 6 Nov. The same issue was round 1, Q31 on Calvera SC.
The GSPR mapper never marks a line evidenced without a page citation.
Device classification, sterilisation method, shelf life, UDI-DI, Basic UDI-DI, intended purpose, storage conditions and rated burst pressure are read from 46 places in 14 documents, each value with its page. Five facts are the same everywhere. Three disagree, and each red cell opens both pages.
Side by side: the device description and specification DS-114 rev C, p. 12, reads 36 months from date of manufacture; the label artwork LA-0388 rev B, panel 2, sets use-by at date of manufacture + 24 months. Change record CR-0412, approved by Annika Brandt on 18 Mar 2025, extended shelf life to 36 months on the accelerated aging report TR-2291 rev C (ASTM F1980, 55 °C). It listed DS-114, MP-220 and the GSPR checklist as affected — not the label artwork or the IFU.
“The agents never choose the value. The fix goes through change control; the ring stays red until the corrected document is released.”
Three options: align the label artwork and IFU to 36 months, keep 24 months and correct the design file until real-time aging confirms 36 (Mar 2028), or mark it not a contradiction with a written reason. The evidence supports the first. Ingrid decides and assigns: change CR-0431 for LA-0388 and IFU-0388 §11, owner Tomás Reyes, due 24 Oct, approval Annika Brandt.
The notified body asked before — round 1, Q14: “Provide the evidence supporting the shelf life stated on the label and confirm it is consistent with the device description.”
DS-114 p. 9 and the bench report TR-2207 give 18 atm, demonstrated at 99.9% reliability and 95% confidence. The IFU v4 compliance chart on p. 7 says 20 atm, because it was rebuilt in 2024 from the Calvera SC template. The third, C-03, is a UDI-DI with its last two digits swapped in the draft Declaration of Conformity — a number that fails the GS1 check digit.
Supported by the evidence: correct the IFU compliance chart to 18 atm — change CR-0432, Tomás Reyes, due 24 Oct.
Eleven gaps, each with the line it breaks, what is missing, the fix, an owner or a suggested owner, and a due date: residual risks R-12 and R-13 missing from the IFU, a summative usability evaluation run on IFU v3, EO residuals not tested on the 2025 load, no “MD” symbol on the label. Four were asked about by the notified body before. The decided shelf-life change now sits at the top as CR-0431.
G-05: magnetic resonance safety marked “not applicable” with no reason — suggested owner Mateo Lindgren, due 17 Oct.
RA-REV-0388 version 0.3: the scope, results by chapter, the three facts that disagree with the decision on each, or open, the 11 gaps, the 3 standards out of date, and where questions are likely — Q9 symbols, Q14 shelf life, Q22 residual risks, Q31 biological evaluation, Q40 usability. It recommends correcting the three contradictions and closing gaps G-01, G-03 and G-06 before submission.
“With owners and dates as above, submission on 30 Nov 2026 remains achievable.”
Annika Brandt, quality manager, completed the second review at 10:20, as she does for every class III file. Ingrid signs with her name, password and the meaning “Review complete — gaps assigned before submission”. Contradictions still open stay on the report as open items, and version 1.0 is kept with the technical file.
The review report writer never signs or submits anything.
The same file, seen by the four people who carry it to the notified body — what their review looked like, and what it looks like now.
Five specialist agents index, map, check and cross-read every technical file; a regulatory lead decides and signs.
Reads every document in the technical file and sorts it into the six sections of Annex II, with document number, title, revision, pages and release status. Superseded revisions and drafts are read but set aside.
Decides for each line of the GSPR checklist whether it applies to the device, finds the passage that meets it and cites document, revision and page, names the standard applied, opens a gap where there is none and drafts a reason for every line that does not apply.
Lists every standard the file cites and compares the edition cited with the current and harmonised edition — 24 standards on the sample file, 3 out of date.
Reads the same fact from every document that states it, compares the values and shows any disagreement side by side with every other statement and the change record or template history that explains it.
Drafts the pre-submission review report from the results: chapter totals, contradictions and their decisions, gaps with owners, standards out of date and where questions are likely.
Decides every contradiction and signs. The agents propose; a named person decides.
Ask in plain words, or say what to change. Every answer points to the page it came from.
Where will the notified body ask first?
In section 23, labels and IFU — it sits at 80% and drew 22 of the 61 questions on Calvera SC. Two facts disagree there: shelf life is 36 months in the design file and 24 months on the label artwork — exactly what Q14 asked about last time — and the UDI-DI is mistyped in the draft declaration. Next: residual risks (section 4, Q22) and the biological evaluation edition (section 10, Q31).
Why does the shelf life disagree?
Change record CR-0412 extended shelf life to 36 months in March 2025 on the accelerated aging report TR-2291 rev C. The label artwork was released in January 2025 with date of manufacture + 24 months, and CR-0412 did not list it as affected — nor the IFU. The evidence supports aligning the label and IFU to 36 months; real-time aging will confirm it by March 2028.
Which standards are out of date?
Three of 24. The biological evaluation report cites ISO 10993-1:2009; the current edition is 2020 (gap G-03, asked as Q31 last time). The EO residuals report cites EN ISO 10993-7:2008 without its 2022 amendment. The label and IFU use symbols from EN ISO 15223-1:2016; the current edition is 2021 (gap G-06, Q9).
Assign the gaps no one owns
Done. G-05 (MR safety marked not applicable with no reason) goes to Mateo Lindgren, due 17 Oct, and G-10 (three IFU translations) to Tomás Reyes, due 13 Nov. Both owners get a task; every gap now has an owner before the 30 Nov submission.
13 screens from the working solution, on its sample data. Pick one to see it large.
How a technical file is reviewed is set once, in settings — the checklist, the evidence rules, the facts to cross-check and who signs.
| Setting | Default | Choose from |
|---|---|---|
| GSPR checklist | Corvane template v5 · 181 lines | Annex I broken into the lines your reviewers answer |
| Evidence must cite document, revision and page | On | On · off — a line without a page reference stays a gap |
| “Not applicable” needs a reason | On | On · off — drafted by the agents, accepted by the regulatory lead |
| Use only released revisions | On | On · off — drafts and superseded revisions are read, never cited |
| Facts to cross-check | 8 facts | Each fact on or off · add a fact |
| Standards editions | Refreshed monthly | Current editions and the harmonised standards list |
| Notified body question history | Calvera SC, 2025 · 3 rounds · 61 questions | Imported — used to mark where questions are likely |
| Sign-off | Regulatory lead signs · quality manager second review for class III | Electronic signature with name, time and meaning |
Every figure is labelled: a target the solution is built to, an estimate, a typical published result, or a proven one.
“demo” = seen in the working solution, on its sample technical file · “target” = the design goal, measured in the live solution · “estimated” = our estimate · “typical” = published figures (European Commission notified body survey, 2025 — most often 13–18 months to an MDR certificate). Regulation (EU) 2017/745 Annex I and II; Regulation (EU) 2023/607 for the 31 Dec 2027 and 2028 transition deadlines. People, companies, devices and sales figures named on this page are fictional — characters and sample data in the working solution.
It is the check, before submission to a notified body, that the Annex II technical documentation proves the device meets every applicable General Safety and Performance Requirement in Annex I of Regulation (EU) 2017/745. EU MDR Technical Documentation Review does it with five agents that map each GSPR line to the document, revision and page that meets it, check standard editions and cross-read facts between documents, for a regulatory lead to decide and sign.
The GSPR mapper works through your own checklist template line by line. For each line it decides whether it applies, cites the passage that meets it with document, revision and page and the standard applied, opens a gap where there is no evidence and drafts a reason for every line that does not apply — which the regulatory lead accepts.
The consistency checker reads a list of facts — classification, sterilisation method, shelf life, UDI-DI, Basic UDI-DI, intended purpose, storage conditions, rated burst pressure — from every document that states them. Values that disagree open as two pages side by side, with every other statement and the change record that explains the difference. You can add your own facts to the list.
Yes. The standards checker lists every standard the file cites and compares the edition cited with the current edition and the harmonised standards list, refreshed monthly. A superseded edition, or an amendment not applied, needs an update to the document or a written justification.
No. The agents never choose the value in a contradiction and never edit a controlled document; released documents are read from your document control system and nothing is written back. The regulatory lead decides, and every fix goes through change control with a version.
Yes. The regulatory lead decides every contradiction, accepts or rejects each “not applicable” reason and signs the review report with name, time and meaning. For class III files the quality manager completes a second review first, and the report writer never signs or submits anything.
No. Its scope is the technical documentation under Annex II — device description, information supplied, design and manufacture, the GSPR, benefit-risk and risk management, and verification and validation.
The Agentic Solution Engine builds and deploys it from your requirements and documents — your GSPR checklist template, review rules, standards list and a released technical file — and it goes live once every quality gate has passed. We will walk you through it on one of your own legacy device files first.
Every agency change reaches the right team within hours, with what changed marked.
1-min demoCTD Module 2 AuthoringModule 2 summaries drafted in weeks, every statement cited to its source.
1-min demoHealth Authority Query ResponseCited first drafts within hours, consistent with every past answer to every agency.
1-min demoWe'll run EU MDR Technical Documentation Review on one of your own legacy device files.