GSPR Checklist Template - MDR

GSPR Checklist Template – MDR

€69.00

SKU GSPR-MDR-001 Categories , Tags , ,

ISO 13485 & MDSAP Ready

Editable Word & Excel

ISO 13485 / MDSAP / FDA QMSR

Used by 100+ quality teams

GSPR Checklist Template — EU MDR

What it is: an operational Excel checklist mapping all 159 General Safety and Performance Requirements of EU MDR Annex I. Every requirement, the standard applied, the evidence document and the compliance status, in one filterable view that a Notified Body auditor can read in 10 minutes.

What is included

  • All 159 GSPRs of MDR Annex I (Chapters I, II, III)
  • 9 columns: GSPR ID, requirement, applicability, suggested standards, applied standards, evidence IDs, compliance status, comments, last review date
  • Applicability dropdown (Applicable / Not applicable / Partially applicable)
  • Compliance status dropdown with conditional color formatting
  • Pre-configured filter rows for fast navigation
  • Latest harmonised standards: EN ISO 14971:2019/A11:2021, EN ISO 13485:2016/A11:2021, EN ISO 10993-1:2020, EN ISO 10993-10:2023, EN ISO 11607-1:2020/A1:2023, EN IEC 62366-1:2015/A1:2020
  • References to MDCG 2019-11, 2019-16, 2020-5, 2020-13

Format

1 Microsoft Excel .xlsx file (fully editable, Excel 2016+ or LibreOffice Calc compatible) + slim README with usage instructions. Delivered as a small ZIP. Instant download after purchase.

Need the full risk file?

This is 1 of 6 templates in the Risk Management Documentation Kit. Save 16% with the bundle: EUR 349 vs EUR 414 buying individually.

€69.00

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Alessandro Stella

Alessandro Stella is a freelance Medical Device Regulatory Consultant and ISO 13485 / ISO 9001 Lead Auditor based in Italy. With over 13 years of experience spanning R&D, Quality, and Regulatory Affairs, he has supported companies across Europe and beyond in EU MDR technical documentation, QMS implementation, ISO 13485 compliance, and FDA submissions. His device expertise covers cardiovascular devices, AI-based standalone software, robotic surgery systems, active wearables, and more. Alessandro is the founder of MD Regulatory.