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EU MDR Software Requirements (incl. Rule 11)

Classify medical device software under EU MDR Rule 11 and map GSPRs.

26|6|Updated Jan 4, 2026
Search Tags:#technical documentation#regulatory#medical device#eu mdr#software compliance#rule 11#gspr
One-click install
npx skills add https://github.com/AminAlam/meddev-agent-skills --skill eu-mdr-software-requirements-incl-rule-11
Or copy as Structured Prompt for Agent▼
Please help me install this Agent Skill.
Skill: EU MDR Software Requirements (incl. Rule 11)
Source: https://github.com/AminAlam/meddev-agent-skills/tree/main/regulatory/eu-mdr
Command: npx skills add https://github.com/AminAlam/meddev-agent-skills --skill eu-mdr-software-requirements-incl-rule-11

SYSTEM DOCUMENTATION & REQUIREMENTS

💡 This Skill includes references (resource) components.

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.

Frequently Asked Questions about EU MDR Software Requirements (incl. Rule 11)

High-intent search queries and answers about installing and using this skill.

FAQPage Schema
How do I classify medical device software under EU MDR Rule 11?▼

To classify medical device software under EU MDR Rule 11, you must evaluate its intended purpose and vulnerability to risks. This Skill guides you through Rule 11 classification criteria and maps software features to determine the correct regulatory class.

How do I map software requirements to EU MDR General Safety and Performance Requirements (GSPRs)?▼

Mapping software requirements to EU MDR GSPRs involves aligning design features with Annex I safety and performance criteria. This Skill provides structured guidance to map software features directly to applicable GSPRs for compliant technical documentation.

What technical documentation is required for EU MDR software compliance?▼

EU MDR software compliance requires technical documentation covering risk management, post-market surveillance, and interoperability per Annex II/III. This Skill guides the creation of complete MDR-compliant technical documentation files.

Does my software update affect its EU MDR classification or intended purpose?▼

Software updates can alter EU MDR classification or intended purpose if they change diagnostic or therapeutic functions. This Skill helps assess updates against Rule 11 criteria to determine if regulatory reclassification or new documentation is required.

How do I manage cybersecurity and interoperability risks for EU MDR medical device software?▼

Managing cybersecurity and interoperability risks for EU MDR software involves addressing specific MDCG guidance requirements. This Skill guides the integration of risk management and interoperability controls into your MDR technical documentation.

When do I need UDI and post-market surveillance (PMS/PMCF) for medical device software?▼

UDI and post-market surveillance (PMS/PMCF) are required for all EU MDR medical device software throughout its lifecycle. This Skill provides guidance on establishing UDI requirements and structuring PMCF plans to satisfy MDR obligations.

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