Description
GSPR Checklist Builder Tool
The Automated GSPR Checklist Template for EU MDR 2017/745 Compliance
Building a General Safety and Performance Requirements (GSPR) checklist for EU MDR 2017/745 compliance is one of the most time-consuming tasks in medical device technical documentation. Our GSPR Checklist Builder is an automated Excel Add-In and template designed to do the heavy lifting for you — generating a fully structured GSPR checklist template in a fraction of the time, with one-click export directly to Word.
Designed for regulatory affairs professionals and medical device manufacturers, this tool eliminates manual errors, ensures nothing is missed, and produces documentation ready for notified body review or internal audit.
Key Features
Automated GSPR Checklist Generation
Answer 19 questions about your device and the tool automatically determines which GSPRs apply and pre-populate applicability status and generating rationale for non-applicable requirements. No more building your GSPR checklist template from scratch
Pre-Built, Customisable Template
Includes a fully structured GSPR checklist sheet with pre-built logic aligned to Annex I of EU MDR 2017/745. Fully editable to meet the specific requirements of your device.
Document Integration & Auto-Population
Manage all your supporting document references in a dedicated Documents Sheet. The tool automatically links your risk management, clinical evaluation, and technical documentation to the corresponding GSPRs.
Smart Excel Ribbon Add-In
Adds a dedicated “GSPR Tools” tab directly into Excel for a seamless workflow. Includes buttons for highlighting applicable GSPRs, splitting rows for multiple document references, and resetting selections.
One-Click Export to Word
Convert your completed GSPR checklist into a professionally formatted Word document in one click, ready for regulatory submissions, notified body audits, or internal QMS records.
Save Time & Ensure Compliance
Eliminates the hassle of manual GSPR checklist creation. Reduces human error and improves consistency across compliance documentation.
How It Works
- Setup Your Checklist: Answer the initial questionnaire to determine which GSPRs apply.
- Auto-Populate Your GSPRs: Import and link supporting documents to the checklist.
- Customize & Edit: Adjust applicability, add references, and manage documentation.
- Export & Submit: Convert your checklist into a Word document for submission or internal review.
Who is this for?
This tool is built for anyone responsible for EU MDR technical documentation, including:
- Regulatory affairs managers and consultants
- Quality and compliance teams at medical device manufacturers
- Notified body consultants preparing or reviewing technical files
- Small manufacturers who need a structured, affordable GSPR checklist template without custom software
Frequently Asked Questions
What is a GSPR checklist? A GSPR checklist is a structured document required under EU MDR 2017/745 that demonstrates how a medical device meets each of the General Safety and Performance Requirements set out in Annex I of the regulation. It is a mandatory component of the technical documentation for CE marking.
Is this tool compliant with EU MDR 2017/745? Yes — the checklist structure and requirements are aligned to Annex I of EU MDR 2017/745. The tool guides you through each applicable requirement and generates documentation suitable for notified body review.
Can I use this for IVDR compliance? The tool is designed specifically for EU MDR 2017/745. While there is overlap with IVDR requirements, we recommend confirming applicability for your specific device category before use.
What do I need to use the tool? Microsoft Excel (2016 or later) is required to run the Add-In. The Word export function requires Microsoft Word. The tool is not compatible with Google Sheets or Mac versions of Excel.
Is this an automated GSPR checklist or a manual template? Both — the tool starts with an automated questionnaire that determines applicability for your device, then generates a pre-populated GSPR checklist template that you can further customise. It combines the speed of automation with the flexibility of a fully editable template.
Get Started Immediately
Instant Download – Get your copy immediately after purchase.
Comprehensive User Guide – Step-by-step instructions included.
Customer Support – Reach out anytime for assistance.
Reviews
There are no reviews yet.