How many controls does EU In Vitro Diagnostic Medical Devices Regulation have?

EU In Vitro Diagnostic Medical Devices Regulation contains 23 controls organized across 6 domains.

Where does EU In Vitro Diagnostic Medical Devices Regulation apply?

EU In Vitro Diagnostic 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 In Vitro Diagnostic Medical Devices Regulation map to?

EU In Vitro Diagnostic Medical Devices Regulation has control-to-control mappings with 352 other compliance frameworks in our database. Use our compliance platform to explore these mappings interactively.

How do I get started with EU In Vitro Diagnostic 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 In Vitro Diagnostic Medical Devices Regulation (IVDR)

The EU In Vitro Diagnostic Regulation (EU 2017/746) establishes the regulatory framework for IVD medical devices in the European Union. Effective May 26, 2022 (with transitional provisions through 2028), it replaces the IVD Directive 98/79/EC.

Domains

Post-Market Surveillance and Vigilance

Clinical Evidence and Performance

Notified Bodies and Conformity Assessment

Identification, Traceability and Registration

Market Placement and Economic Operators

Frequently Asked Questions

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