EU MDR Software Requirements (incl. Rule 11)

What problem does it solve?

This Skill provides clear, actionable guidance to ensure medical device software complies with the stringent requirements of the EU Medical Device Regulation (MDR), particularly focusing on classification rules and technical documentation.

Core Features & Use Cases

• Rule 11 Classification: Helps determine the correct software classification under MDR Annex VIII, Rule 11.
• GSPR Alignment: Maps software features and requirements to the General Safety and Performance Requirements (GSPRs) of the MDR.
• Technical Documentation: Guides the creation of MDR-compliant technical documentation, including risk management and post-market surveillance.
• Use Case: A developer is updating software for a diagnostic imaging device intended for the EU market. This Skill helps them ensure the software's classification is correct, all relevant GSPRs are addressed in the design and documentation, and that cybersecurity and interoperability risks are properly managed according to MDCG guidance.

Quick Start

Use the EU MDR skill to classify software under Rule 11 and map it to GSPRs.