IVDR Risk Management Documentation Kit
€349.00
ISO 13485 & MDSAP Ready
Editable Word & Excel
ISO 13485 / MDSAP / FDA QMSR
Used by 100+ quality teams
EU IVDR · ISO 14971 · ISO/TR 24971 · Annex I
IVDR Risk Management Documentation Kit
A risk file that treats a wrong result as the hazard it actually is — because for a diagnostic the harm is indirect, and a hazard library written for therapeutic devices does not reach it.
€349
VAT calculated at checkout
6 templates · 4 Word + 2 Excel
Auto-calculated risk priority · GSPR checklist
ISO 14971 does not change. The hazard library does.
The process transfers from the MDR unchanged: plan, hazard identification, risk estimation, risk control, residual risk, benefit-risk, production and post-production information. None of that is different for a diagnostic.
What is different is what can go wrong. A risk file built on energy, biocompatibility and mechanical failure is visibly the wrong file for an in vitro diagnostic, and the benefit-risk analysis built on top of it weighs the wrong things.
The process itself is covered in the ISO 14971 guide. For an IVD the harm is almost always indirect: it arises from a medical decision taken, or not taken, on the basis of a result. The chain runs from an event — a degraded reagent, a cross-reacting substance, an instrument fault — through a hazard expressed as a false negative, a false positive, a delayed, absent or unclear result, to a hazardous situation in which someone acts on it, to the harm that follows. This kit is built on that chain throughout.
- 6 templates
- 4 Word + 2 Excel
- EN ISO 14971:2019/A11:2021
- ISO/TR 24971:2020
- Annex I IVDR GSPR checklist
- Free updates
Contents
Six coordinated templates
Audience
Who the kit is for
- Manufacturers of in vitro diagnostics of any class — risk management applies regardless of classification
- Organisations whose ISO 14971 file was written for medical devices and now has to serve a diagnostic portfolio
- Devices self-certified under the IVDD being brought under a notified body for the first time
- Quality managers preparing for a notified body audit of the risk management process
- Consultants who need an IVD hazard framework rather than a generic one
What is included
What you get when you buy
- 4 Microsoft Word templates and 2 Microsoft Excel workbooks, editable, with working formulas and no macros
- The GSPR checklist for Annex I of Regulation (EU) 2017/746, with the evidence column Annex II Section 4 requires
- Worked IVD examples in the hazard inventory and in both FMEA workbooks
- User profiles for laboratory, point-of-care and lay-user settings
- Cover page, revision history and approval table on every document
- Instant download after purchase, and free updates for regulatory changes
Questions
Before you buy
Is this a completed risk analysis?
No. The hazard inventory and the FMEA workbooks contain worked examples that show the level of detail expected. The hazards of your device have to be identified by people who know it.
Do I still need the standards?
Yes. The kit implements EN ISO 14971:2019/A11:2021 and draws on ISO/TR 24971:2020, and you should hold licensed copies of both.
I already own the MDR risk kit. What do I gain?
The process is common to both regulations, so four of the six templates are recognisable. What you do not have is the Annex I IVDR GSPR checklist or the IVD hazard content — and those are the parts that decide whether the file reads as a diagnostic file. The GSPR checklist guide explains the column structure both versions use.
Where do the acceptance criteria go?
Into the performance evaluation. How much diagnostic sensitivity a device needs depends on the severity of the harm a false negative causes, which is set here. The Performance Evaluation Kit is where those criteria are applied, and Section 5 of the Technical Documentation Kit is where this file is referenced.
Does the GSPR checklist cover all of Annex I?
Yes, every requirement across the three chapters, with applicability, justification for the ones that do not apply, standards applied, and the evidence reference with document, revision and section.
Do the Excel workbooks contain macros?
No. They use working spreadsheet formulas only, so they open and calculate in any environment without security warnings.
Does it apply to class A devices?
Yes. Risk management under Annex I Section 3 applies to every class, and so does the GSPR demonstration.
What format are the files in?
Microsoft Word and Microsoft Excel, fully editable, no macros and no protection.
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.
IVDR Risk Management Documentation Kit
6 coordinated templates — plan, report, hazard analysis, two active FMEA workbooks and the Annex I GSPR checklist. Instant download, free updates, no expiry.
€349.00
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