EU IVDR Technical Documentation Kit
€429.00
ISO 13485 & MDSAP Ready
Editable Word & Excel
ISO 13485 / MDSAP / FDA QMSR
Used by 100+ quality teams
EU IVDR · Annex II · Annex III · Annex IV
EU IVDR Technical Documentation Kit
The full Annex II technical file for an in vitro diagnostic, in the order the Regulation itself sets — so a completeness check runs straight through instead of stopping on the first section.
€429
VAT calculated at checkout
8 Word templates · Annex II to Annex IV
Instant download · free updates
Most IVDR files fail on structure, not on science
The assay is validated. The stability data are real. And then Section 6 is filed as a single block, labelling sits at the back, and the GSPR checklist names the evidence without saying where it is.
None of that is a scientific problem. All of it is found during the completeness check, in an afternoon, before anyone opens a study report — and every one becomes a question that has to be answered before the substantive review can begin. The Annex II structure is walked section by section on the blog, and the IVDR guide covers the wider framework around it.
This kit removes that entire category of finding. Each template maps to one section of Annex II of Regulation (EU) 2017/746, with the sub-elements broken out individually, the guidance written inline where a requirement is easy to misread, and the cross-references between documents already in place.
- 8 Word templates
- Annex II sections 1 to 6
- Annex III and Annex IV
- Fully editable
- No macros
- Free updates
Contents
Eight templates, one per Annex II section
Audience
Who the kit is for
- Manufacturers building an IVDR technical file for the first time
- Manufacturers converting a file assembled under Directive 98/79/EC
- Consultants who need a defensible structure rather than a blank page
- Quality managers who inherited a file and have to work out what is missing
- Regulatory affairs teams extending an MDR process to a diagnostic portfolio
The kit assumes you have the evidence — the validation reports, the stability studies, the performance data. What it provides is the structure that presents them, the applicability decisions, and the guidance on the requirements most often misread. Where that evidence comes from is the subject of the Performance Evaluation Kit.
What is included
What you get when you buy
- 8 Microsoft Word templates, editable and unlocked, with no macros
- Cover page, revision history, author, reviewer and approver on every document
- An updatable table of contents, list of tables and figures, and list of acronyms
- Compliance checklists against the Annex II section each document satisfies
- Cross-references already written between the eight documents
- Instant download after purchase, and free updates for regulatory changes
Questions
Before you buy
Is this a completed technical file?
No. Every template contains placeholders that require your device, your data and your decisions. No template can make a classification decision or write an intended purpose for you.
Does it include the performance evaluation?
No. Section 6.2 references the performance evaluation report and its three constituent reports; those documents are in the EU IVDR Performance Evaluation Kit. The principles behind them are explained in the MDCG 2022-2 guide.
Does it include the risk management file?
No. Section 5 references it, and the documents are in the IVDR Risk Management Documentation Kit. The Complete Bundle carries all three and costs €178 less than buying them separately.
Does it work for class A devices?
Yes. Every device placed on the EU market needs technical documentation meeting Annex II and Annex III regardless of class. For a self-declared class A device no notified body reviews the file, but a competent authority can request it at any time.
Can I use my MDR template instead?
The skeleton carries across, because both regulations use a six-section Annex II in the same order. The content does not: Section 6 has a different architecture, and the article and annex references differ throughout.
What format are the files in?
Microsoft Word, fully editable, no macros and no protection. You can rebrand them, renumber them and merge them into an existing document control system.
Do I get updates?
Yes. Updates for regulatory and guidance changes are provided free of charge to existing customers.
Can my company buy several licences?
Yes. Get in touch and we will arrange it, including a single invoice and the details your finance team needs.
EU IVDR Technical Documentation Kit
8 Word templates covering every section of Annex II, with the Annex III post-market documentation and the Annex IV declaration of conformity. Instant download, free updates, no expiry.
€429.00
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