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EU In Vitro Diagnostic Medical Devices Regulation (IVDR)
Regulation (EU) 2017/746 (the IVDR) is the EU horizontal regime for in vitro diagnostic medical devices (IVDs). It applied from 26 May 2022 and replaced Directive 98/79/EC.
Domains
IVDR - Introductory Provisions and Scope (Ch I)
IVDR - Notified Bodies (Ch IV)
IVDR - Classification + Conformity Assessment (Ch V)
IVDR - PMS + Vigilance + Market Surveillance + Final (Ch VII-X)
IVDR - Identification + UDI + Registration + EUDAMED (Ch III)
Compare EU In Vitro Diagnostic Medical Devices Regulation (IVDR)
EU In Vitro Diagnostic Medical Devices Regulation (IVDR) vs ISO 27001:2022View comparison →EU In Vitro Diagnostic Medical Devices Regulation (IVDR) vs SOC 2View comparison →EU In Vitro Diagnostic Medical Devices Regulation (IVDR) vs NIST CSF 2.0View comparison →EU In Vitro Diagnostic Medical Devices Regulation (IVDR) vs GDPRView comparison →EU In Vitro Diagnostic Medical Devices Regulation (IVDR) vs HIPAAView comparison →EU In Vitro Diagnostic Medical Devices Regulation (IVDR) vs PCI DSS 4.0View comparison →
EU In Vitro Diagnostic Medical Devices Regulation (IVDR) by Industry
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EU In Vitro Diagnostic Medical Devices Regulation (IVDR) by Role
EU In Vitro Diagnostic Medical Devices Regulation (IVDR) for CISOs→EU In Vitro Diagnostic Medical Devices Regulation (IVDR) for Compliance Officers→EU In Vitro Diagnostic Medical Devices Regulation (IVDR) for Risk Managers→EU In Vitro Diagnostic Medical Devices Regulation (IVDR) for IT Directors→EU In Vitro Diagnostic Medical Devices Regulation (IVDR) for DPOs→EU In Vitro Diagnostic Medical Devices Regulation (IVDR) for Auditors→
Frequently Asked Questions
What is EU In Vitro Diagnostic Medical Devices Regulation?
Regulation (EU) 2017/746 (the IVDR) is the EU horizontal regime for in vitro diagnostic medical devices (IVDs). It applied from 26 May 2022 and replaced Directive 98/79/EC.
How many controls does EU In Vitro Diagnostic Medical Devices Regulation have?
EU In Vitro Diagnostic Medical Devices Regulation contains 26 controls organized across 7 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 4 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.
How ready are you for EU In Vitro Diagnostic Medical Devices Regulation (IVDR)?
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