Go beyond a checklist. Build defensible compliance.
EU MDR General Safety and Performance Requirements (GSPRs) are one of the most scrutinized sections of any technical file — and one of the most common reasons for Notified Body questions, delays, and non-conformities. Our EU MDR GSPR Compliance Pack is designed by regulatory professionals to help you demonstrate real compliance, not just tick boxes.
This pack gives you a clear, structured, and audit-ready approach to addressing every applicable requirement under Annex I of the EU MDR — with the rationale and clinical linkages that Notified Bodies actually expect to see.
What’s Included in the Pack?
1. EU MDR GSPR Checklist (Annex I)
A comprehensive, clause-by-clause checklist covering all MDR General Safety and Performance Requirements, structured to:
- Clearly identify applicable vs non-applicable requirements
- Map evidence to each requirement
- Support Technical Documentation and Notified Body review
2. GSPR Rationale for Non-Applicable Clauses
Not all GSPRs apply to every device — but you must justify why.
This document provides a dedicated, structured format to:
- Clearly explain non-applicability
- Avoid vague or insufficient justifications
- Reduce follow-up questions during conformity assessment
A critical but often missing piece in many technical files.
3. GSPRs Requiring Clinical Support
Clinical evidence is one of the most sensitive and heavily reviewed areas under MDR.
This document helps you:
- Identify which GSPRs require support from clinical data
- Create traceability between GSPRs and your clinical evaluation
- Strengthen alignment between Annex I, your CER, and performance claims
Perfect for manufacturers struggling with clinical linkage and justification.
PNS MED HEALTH 