GSPR Checklist Template - MDR 2017/745

Ensure full compliance with the EU Medical Device Regulation (MDR) 2017/745 and ISO 13485:2016 Clause 4.2 requirements with our Medical Device File MDR General Safety and Performance Requirements (GSPR) Checklist Template. This structured checklist provides a comprehensive framework to help manufacturers demonstrate conformity with the MDR's Annex I GSPR requirements, ensuring that all safety, performance, and regulatory obligations are met.

✔ Pre-Formatted MDR GSPR Checklist – Covers key ISO 13485:2016 Clause 4.2 and MDR Annex I requirements.

✔ General Safety & Performance Requirements (GSPR) Mapping – Ensure each requirement is linked to supporting documentation.

✔ Compliance Assessment & Evidence Tracking – Identify gaps and record justifications for compliance.

✔ Risk Management & Clinical Evaluation Sections – Align with ISO 14971 risk assessment and clinical validation.

✔ Labeling, UDI & Post-Market Surveillance Sections – Verify compliance with MDR-specific regulatory expectations.

✔ Approval & Sign-Off Workflow – Assign responsibilities for review and approval.

✔ Editable Digital Format – Fully customizable for various medical device classifications.

This ready-to-use checklist is essential for regulatory teams, quality managers, and medical device manufacturers, ensuring a structured, compliant, and audit-ready documentation process.

Download the ISO 13485:2016 Medical Device File MDR GSPR Checklist Template today and simplify your MDR compliance process!