General Safety and Performance checklist

Ensure your medical device complies with the General Safety and Performance Requirements (GSPR) as mandated by Annex I of EU MDR 2017/745 using our comprehensive GSPR Template. Designed for medical device manufacturers and regulatory teams, this user-friendly template helps you systematically demonstrate that your device meets all the essential safety and performance criteria for market approval in the European Union.

Key Features:

• EU MDR Annex I Compliant: Fully aligned with the detailed requirements of Annex I of the EU MDR 2017/745, ensuring you cover all the necessary safety and performance standards.
• Complete Section Coverage: The template includes all relevant GSPR sections, from general safety and performance principles to list of applicable standards and relevant documents references.
• Step-by-Step Guidance: Each section comes with clear instructions and example on how to fill in the required information, making it easier for teams of all experience levels to complete the template accurately.

What’s Included?

• Fully Editable GSPR Template: Available in Word, format
• Pre-structured Sections: Covering all 23 GSPR requirements from Annex I of EU MDR 2017/745
• Traceability Matrix: Link requirements to the relevant evidence in your technical documentation
• Guidance Notes: Detailed instructions and examples to help you fill out each section accurately

Compliance with Annex I of EU MDR

This General Safety and Performance Requirements (GSPR) Template helps you ensure that your medical device complies with Annex I of EU MDR 2017/745, providing a clear, structured, and traceable path to regulatory success. Whether you are submitting for initial certification or preparing for re-certification, this template simplifies the complex process of demonstrating safety and performance compliance.