GSPR Checklist Template – MDR
€69.00
ISO 13485 & MDSAP Ready
Editable Word & Excel
ISO 13485 / MDSAP / FDA QMSR
Used by 100+ quality teams
EU MDR Annex I · 159 GSPRs
GSPR Checklist Template — EU MDR
All 159 General Safety and Performance Requirements of Annex I, each one with its applicable standard, evidence reference and status, in a view a Notified Body auditor reads in ten minutes.
€69
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Excel .xlsx · 159 GSPRs · README included
Instant download
The checklist has conclusions, not evidence
A GSPR checklist built as a tick-box list answers “met” or “not met” for each of the 159 requirements, with nothing behind the answer. An auditor’s first question is where the evidence lives, and a column that says “yes” does not answer it.
A checklist that works records, for every requirement: whether it applies, which standard was applied, where the evidence sits, and when it was last reviewed — filterable, so a reviewer can isolate the partially applicable rows in seconds rather than reading 159 lines in order.
None of this is difficult. It is the consequence of building a checklist to be filled in rather than to be read.
- Excel .xlsx
- 159 GSPRs
- 9 columns
- Filterable
- Colour-coded status
- Instant download
Scope
What the template covers
Every General Safety and Performance Requirement of MDR Annex I, Chapters I, II and III, cross-referenced to the current harmonised standards and MDCG guidance.
01
All 159 requirements
Every GSPR of Annex I, Chapters I to III, with nine columns: ID, requirement, applicability, suggested standards, applied standards, evidence IDs, compliance status, comments, last review date.
02
Applicability and status
An Applicability dropdown (Applicable, Not applicable, Partially applicable) and a Compliance status dropdown with conditional colour formatting.
03
Standards and guidance
Pre-loaded references to the latest harmonised standards — EN ISO 14971, EN ISO 13485, EN ISO 10993-1, EN ISO 10993-10, EN ISO 11607-1, EN IEC 62366-1 — and to MDCG 2019-11, 2019-16, 2020-5 and 2020-13.
Contents
What the workbook contains
Audience
Who the template is for
- Regulatory affairs and quality managers assembling an MDR technical file
- Manufacturers whose current checklist has no evidence trail
- Consultants preparing a Notified Body submission for review
The template assumes you have, or are building, the underlying evidence: risk file, clinical evaluation, verification and validation reports. It does not teach MDR Annex I: it gives you a working checklist to record where that evidence sits.
What is included
What you get when you buy
- 1 Microsoft Excel .xlsx file, fully editable
- Compatible with Excel 2016+ or LibreOffice Calc
- A slim README with usage instructions
- Delivered as a small ZIP, instant download after purchase
Questions
Before you buy
Does this cover all 159 GSPRs?
Yes, all of them, across Chapters I, II and III of Annex I.
Does it reference the risk file and clinical evidence?
It has evidence-ID columns for you to reference them; it does not contain the risk file or clinical evaluation itself. The Risk Management Documentation Kit and the EU MDR Clinical Documentation Kit produce that underlying evidence.
Is this the whole technical file?
No. This is one of six coordinated risk documents. The GSPR checklist references the risk and clinical evidence; the EU MDR Technical Documentation Kit covers the rest of the Annex II file.
Can I buy the full risk kit instead?
Yes. This template is one of six in the Risk Management Documentation Kit, priced at €349 against €414 buying all six separately.
What software do I need?
Microsoft Excel 2016 or later, or LibreOffice Calc.
Is this a one-off purchase?
Yes. The licence is for single-organisation use and the file is yours to keep.
Need the full risk file?
This template is one of six in the coordinated kit.
The Risk Management Documentation Kit ships this checklist alongside the Risk Management Plan, Report, Hazard Analysis and both FMEAs, all built on one shared hazard list. €349 against €414 buying the six separately.
GSPR Checklist Template — EU MDR
One Excel workbook, all 159 requirements, an evidence trail an auditor can follow.
€69.00
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