How many controls does EU Medical Devices Regulation have?

EU Medical Devices Regulation contains 20 controls organized across 4 domains.

Where does EU Medical Devices Regulation apply?

EU Medical Devices Regulation is applicable in European Union. Organizations operating in or serving customers in this jurisdiction should evaluate its requirements.

What frameworks does EU Medical Devices Regulation map to?

EU Medical Devices Regulation has control-to-control mappings with 442 other compliance frameworks in our database. Use our compliance platform to explore these mappings interactively.

How do I get started with EU Medical Devices Regulation compliance?

Start by understanding the framework's key controls and domains. Our compliance platform provides AI-powered gap analysis and mapping tools to help you assess your current posture and build a remediation plan.

EU Medical Devices Regulation (MDR 2017/745)

Regulation (EU) 2017/745 on medical devices replaces Directives 90/385/EEC and 93/42/EEC. It establishes a comprehensive regulatory framework for medical devices in the EU covering the entire product lifecycle from design and manufacturing through post-market surveillance.

Domains

Annex I — General Safety and Performance Requirements

Chapter II — Device Classification and Conformity

Chapter III — Economic Operators

Chapter VII — Post-Market Surveillance

Frequently Asked Questions

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