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EU Medical Devices Regulation (MDR 2017/745)
Regulation (EU) 2017/745 (the MDR) is the EU horizontal regime for medical devices and accessories, replacing the prior MDD (93/42/EEC) and AIMDD (90/385/EEC) framework. It applied from 26 May 2021.
Domains
MDR - Making Available + Economic Operators (Ch II)
MDR - Identification, UDI, Registration and EUDAMED (Ch III)
MDR - Scope, Definitions and General Provisions (Ch I)
MDR - Classification + Conformity Assessment (Ch V)
MDR - Notified Bodies (Ch IV)
Compare EU Medical Devices Regulation (MDR 2017/745)
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EU Medical Devices Regulation (MDR 2017/745) by Industry
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EU Medical Devices Regulation (MDR 2017/745) by Role
EU Medical Devices Regulation (MDR 2017/745) for CISOs→EU Medical Devices Regulation (MDR 2017/745) for Compliance Officers→EU Medical Devices Regulation (MDR 2017/745) for Risk Managers→EU Medical Devices Regulation (MDR 2017/745) for IT Directors→EU Medical Devices Regulation (MDR 2017/745) for DPOs→EU Medical Devices Regulation (MDR 2017/745) for Auditors→
Frequently Asked Questions
What is EU Medical Devices Regulation?
Regulation (EU) 2017/745 (the MDR) is the EU horizontal regime for medical devices and accessories, replacing the prior MDD (93/42/EEC) and AIMDD (90/385/EEC) framework. It applied from 26 May 2021.
How many controls does EU Medical Devices Regulation have?
EU Medical Devices Regulation contains 26 controls organized across 7 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 5 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.
How ready are you for EU Medical Devices Regulation (MDR 2017/745)?
Answer 25 questions and get a professional readiness report with gap analysis, maturity scores, and prioritised action items. Results in 5 minutes.