The European Medical Device Regulation (EU MDR) is a regulatory framework for medical devices produced in or supplied to Europe. It replaces the Medical Device Directive (MDD), which has been in effect since the 1990s; the Active Implantable Medical Devices (AIMD); and the In-vitro Diagnostic Directive (IVDD). As with the FDA’s Unique Device Identification System (UDI System), EU MDR establishes a standard and consistent regulatory framework for medical devices to ensure a high level of health and safety while supporting innovation.

With MDD, European countries differ in their interpretation and implementation of the directive. In a move toward increased uniformity, EU MDR enforces stricter pre-market control of high-risk devices, adds a new risk classification for diagnostic medical devices, and increases transparency by providing a comprehensive EU database of medical devices (Eudamed). Now included are certain aesthetic products with the same characteristics and risk profile as equivalent medical devices.

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  1. The basics of EU MDR
  2. Who EU MDR impacts
  3. When EU MDR takes effect
  4. EU MDR’s impact on clinical data collection
  5. How to collect EU MDR-compliant clinical data
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