GSPR Template – EU MDR Compliance
The GSPR Template by EasyQ Solutions helps demonstrate compliance with EU MDR 2017/745 Annex I General Safety and Performance Requirements (GSPR). This GSPR Template ensures medical devices are safe, effective, and meet regulatory standards.
The GSPR Template provides a structured approach to document safety, performance, and risk management, including purpose, scope, standards, and a compliance checklist.
Key Elements
- Device Details: Name and unique ID (UDI-DI)
- Standards: ISO 14971, ISO 13485, IEC 62304, IEC 62366
- Checklist: Verifies compliance and maintains documented evidence
IFU Requirements
The GSPR Template includes:
- Installation, maintenance, and calibration details
- Sterilization and reuse instructions
- Warnings, precautions, and risk information
- Device compatibility and safety guidelines
- Disposal, regulatory, and software security requirements
The GSPR Template supports compliance, risk management, and faster regulatory approval for medical devices.