EU IVDR Documentation
The complete documentation set for Regulation (EU) 2017/746. Three coordinated kits — the Annex II technical file, the Annex XIII performance evaluation and the ISO 14971 risk management file — cross-referenced across all three and built against the current MDCG guidance.
Three kits, three different problems
Each kit answers a question a manufacturer asks at a different point in the project. Buy the one you need now, or take all three in the bundle and save €178.
“My file is complete but the reviewer cannot navigate it.”
EU IVDR Technical Documentation Kit
The full Annex II technical file, one template per section, in the order the Regulation itself sets. Includes the Annex III post-market documentation and the Annex IV declaration of conformity.
- 8 Word templates, Annex II sections 1 to 6
- Section 6 split into 6.1 to 6.5, as the IVDR requires
- GSPR evidence column with document, revision and section
- Cross-references already written between the eight
“We have the data. We do not have the three reports.”
EU IVDR Performance Evaluation Kit
The evidence architecture the IVDR requires and the MDR does not have: scientific validity, analytical performance and clinical performance, assembled into a report that assesses them.
- 11 Word templates, Annex XIII Part A and Part B
- The thirteen elements of the plan, search protocol inside it
- PMPF, PSUR and the summary of safety and performance
- Written against MDCG 2022-2, 2025-5, 2024-4 and 2025-10
“Our risk file was written for therapeutic devices.”
IVDR Risk Management Documentation Kit
A risk file where the hazard is a wrong result and the harm is indirect — the chain that runs from a degraded reagent to a medical decision taken on a false negative.
- 6 templates, 4 Word and 2 active Excel workbooks
- Severity expressed as the clinical consequence of a wrong result
- Design and use-related FMEA with auto-calculated risk priority
- GSPR checklist for Annex I of the IVDR included
What is inside the three kits
Twenty-five templates in Word and Excel, each mapped to the provision it satisfies. The Complete Bundle adds six further documents that are not sold separately.
| ID | Document | Purpose | |
|---|---|---|---|
| Kit 1 — Technical Documentation · 8 templates · €429 | |||
| TD-01 | Device Description and Specifications | Intended purpose with all eight elements of Annex I 20.4.1(c), classification, components, variants, accessories, UDI and previous generations. | |
| TD-02 | Information Supplied by the Manufacturer | Label artwork by packaging level, symbols, instructions for use, language versions and the traceability of every printed performance figure. | |
| TD-03 | Design and Manufacturing Information | Critical ingredients, instrument subsystems, the interpretation algorithm, design controls, and all sites including suppliers and subcontractors. | |
| TD-04 | General Safety and Performance Requirements | The four elements of the demonstration, standards and common specifications applied, and the critical suppliers that affect product conformity. | |
| TD-05 | Benefit-Risk Analysis and Risk Management | The IVD hazard chain, risk acceptability, usability, and the benefit expressed as the provision of accurate medical information. | |
| TD-06 | Product Verification and Validation | Analytical performance, clinical evidence, stability on at least three lots, software verification, and the five specific cases. | |
| TD-07 | Post-Market Surveillance | The plan, the reporting route by class, vigilance and trend reporting, and the eight processes Article 78(3) requires the data to feed. | |
| TD-08 | Declaration of Conformity | The ten-point mapping, notified body and certificates, language versions and triggers for reissue, with the declaration form in the annex. | |
| Kit 2 — Performance Evaluation · 11 templates · €399 | |||
| PE-01 | Performance Evaluation Plan | The thirteen required elements, with the literature search protocol inside the plan and the acceptance criteria fixed before the data exist. | |
| PE-02 | Scientific Validity Report | The association of the analyte with the clinical condition, built from literature and consensus opinion rather than from your own device. | |
| PE-03 | Analytical Performance Report | One subsection per parameter: trueness, precision, sensitivity, specificity, traceability, measuring interval, linearity and cut-off. | |
| PE-04 | Clinical Performance Report | The three permitted sources, the eight regulatory routes for a study under Articles 58 and 70, and safety reporting under Article 76. | |
| PE-05 | Performance Evaluation Report | Six elements with an assessment against each, favourable and unfavourable data, and the gaps numbered so the PMPF plan can cite them. | |
| PE-06 | Post-Market Surveillance Plan | The six information sources mapped one to one, with indicators and thresholds set pre-market and trend triggers kept separate from them. | |
| PE-07 | Post-Market Surveillance Report | For class A and class B. Two required elements, with the analysis that makes them defensible under Article 78(2) and (3). | |
| PE-08 | Periodic Safety Update Report | For class C and class D. The three additional elements, the annual cycle, and the submission route each class requires. | |
| PE-09 | PMPF Plan | The five aims of Section 5.1, objectives traced to the gaps in the report, and the regulatory route determined before a study starts. | |
| PE-10 | PMPF Evaluation Report | Findings against each objective and each aim, with the impact on the performance evaluation and on risk management recorded explicitly. | |
| PE-11 | Summary of Safety and Performance | For class C and class D. All three templates of MDCG 2022-9 rev. 1: professional users, lay persons, and devices for self-testing. | |
| Kit 3 — Risk Management · 6 templates · €349 | |||
| RM-01 | Risk Management Plan | Scope, responsibilities and acceptability criteria, with severity expressed as the clinical consequence of a wrong result. | |
| RM-02 | Risk Management Report | Review of the risk management file, residual risk evaluation and the overall benefit-risk conclusion. | |
| RM-03 | Hazard Analysis | The characteristic questions, hazard categories headed by diagnostic information, and an inventory populated with IVD examples. | |
| RM-04 | Design FMEA | Auto-calculated risk priority, with worked examples on reagent degradation, antibody cross-reactivity and fluidics carry-over. | |
| RM-05 | Use-related FMEA | User profiles for laboratory professional, point-of-care operator and lay user, with use scenarios drawn from real IVD failures. | |
| RM-06 | GSPR Checklist, Annex I IVDR | Every requirement of Annex I with applicability, justification, standards applied and the evidence column Annex II Section 4 requires. | |
All three kits, already cross-referenced
Section 5 of the technical file points at the risk management report. Section 6.2 points at the performance evaluation report. The PMPF plan cites the gaps numbered in that report. Bought separately the documents still fit; bought together they arrive already connected — with six further templates that are not sold on their own.
Technical Documentation
Performance Evaluation
Risk Management
Bundle only — six further templates
Qualification and Classification Rationale, working through all ten implementing rules and every indent of Annex VIII · Technical Documentation Checklist in Word and Excel, 132 elements with gap, action, owner and due date · GSPR Checklist in landscape Word · PRRC Designation Letter with the correct IVDR references · Labelling and IFU Checklist · Strategy for Regulatory Compliance.
⚡ Save €178 (15%) · 31 templates total
Frequently Asked Questions
Which kit should I start with?
If you are building a file from scratch, start with the Technical Documentation Kit: it is the container, and its Section 6.2 and Section 5 tell you what else you need. If the file exists and the notified body has raised findings on the evidence, start with the Performance Evaluation Kit. If your risk file was written for medical devices, start with the Risk Management Kit. The IVDR guide sets out the order the Regulation itself implies.
Are these kits ready to submit to a notified body?
They provide the structure, the methodology and the required content sections, with guidance written inline where a requirement is easy to misread. You populate them with your device, your data and your decisions. No template can make a classification decision or write an intended purpose for you, and none of them generates analytical performance data.
Which IVDR classes are they suitable for?
All of them. Every device placed on the EU market needs technical documentation meeting Annex II and Annex III and a performance evaluation, regardless of class. What changes by class is the reporting cycle and the notified body involvement: class A and B produce a post-market surveillance report under Article 80, class C and D a PSUR under Article 81 plus a summary of safety and performance under Article 29. All those templates are in the Performance Evaluation Kit.
I already own the MDR bundle. Is this a duplicate?
Partly. The risk management process is common to both regulations, so four of the six risk templates will look familiar. What is genuinely new is the Annex I IVDR GSPR checklist, the IVD hazard content where the harm is indirect, and the whole of the technical documentation and performance evaluation kits — Section 6 alone has a different architecture. See Annex II section by section for the comparison.
Which MDCG guidance is reflected?
MDCG 2022-2 for the evidence architecture, MDCG 2025-5 and 2024-4 for performance studies and safety reporting, MDCG 2025-10 for post-market surveillance, MDCG 2022-9 rev. 1 for the summary of safety and performance, MDCG 2020-16 rev. 4 for classification and MDCG 2019-7 rev. 1 for the PRRC. The MDCG 2022-2 guide explains the one that matters most.
What format are the files in?
Microsoft Word and Microsoft Excel, fully editable, with working formulas and no macros and no protection. You can rebrand them, renumber them and merge them into an existing document control system.
How do I get updates when the guidance changes?
Updates for regulatory and guidance changes are provided free of charge to existing customers. This is an area that moves: MDCG 2020-16 has reached revision 4, MDCG 2022-9 revision 1, and the transitional deadlines were extended by Regulation (EU) 2024/1860.
Do you offer consulting on top of the templates?
Yes. For full technical file drafting, performance evaluation authoring, gap analyses and notified body audit preparation we offer dedicated consulting services. Contact us through the consulting page.