MedTech Terms
    The authoritative reference
    All pathsRA · International · 9 terms

    EU MDR Essentials

    The European regulatory vocabulary for placing devices on the EU market.

    1. 1
      Regulatory

      EU Medical Device Regulation(MDR)

      Regulation (EU) 2017/745 governing medical devices in the European Union.
    2. 2
      Regulatory

      EU In Vitro Diagnostic Regulation(IVDR)

      Regulation (EU) 2017/746 governing in vitro diagnostic medical devices in the EU.
    3. 3
      Regulatory

      CE Mark

      Mandatory European conformity mark for medical devices placed on the EU market.
    4. 4
      Regulatory

      Notified Body(NB)

      EU-designated organization that assesses conformity of medical devices.
    5. 5
      Regulatory

      EUDAMED

      European Database on Medical Devices.
    6. 6
      Regulatory

      Unique Device Identification(UDI)

      System for adequate identification of medical devices through distribution and use.
    7. 7
      Post-Market

      Periodic Safety Update Report(PSUR)

      Periodic EU MDR/IVDR report summarizing post-market surveillance findings.
    8. 8
      Post-Market

      Medical Device Vigilance

      Reporting and management of serious incidents and field safety corrective actions.
    9. 9
      Post-Market

      Field Safety Corrective Action(FSCA)

      Action taken to reduce a risk of serious deterioration in health associated with a device.

    Finished the path? Test yourself with the acronym quiz.