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    All pathsRA · International · 9 terms

    EU MDR Essentials

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

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    0 of 9 lessons complete · up next: EU Medical Device Regulation
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    1. 1
      Regulatory

      EU Medical Device Regulation(MDR)

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

      Why this term here: The core regulation (2017/745). Focus on the classification rules and the GSPR you must meet.

    2. 2
      Regulatory

      EU In Vitro Diagnostic Regulation(IVDR)

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

      Why this term here: The IVD counterpart (2017/746). Focus on the class shift from IVDD and what that means for notified-body involvement.

    3. 3
      Regulatory

      CE Mark

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

      Why this term here: The mark that says you meet EU requirements. Focus on what conformity assessment route your class requires.

    4. 4
      Regulatory

      Notified Body(NB)

      EU-designated organization that assesses conformity of medical devices under MDR and IVDR.

      Why this term here: Your independent conformity assessor. Focus on capacity, designation scope, and audit expectations.

    5. 5
      Regulatory

      EUDAMED

      European Database on Medical Devices.

      Why this term here: The EU device database. Focus on which modules are mandatory today and the actor/UDI/certificate flows.

    6. 6
      Regulatory

      Unique Device Identification(UDI)

      System for adequate identification of medical devices through distribution and use.

      Why this term here: The device identifier. Focus on Basic UDI-DI versus UDI-DI/PI and where each appears in labeling and Eudamed.

    7. 7
      Post-Market

      Periodic Safety Update Report(PSUR)

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

      Why this term here: Periodic Safety Update Report. Focus on cadence by class and how it connects to your PMS plan.

    8. 8
      Post-Market

      Medical Device Vigilance

      Reporting and management of serious incidents and field safety corrective actions.

      Why this term here: Serious incident and FSCA reporting. Focus on the timelines and the trend-report criteria.

    9. 9
      Post-Market

      Field Safety Corrective Action(FSCA)

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

      Why this term here: Field Safety Corrective Action. Focus on the FSN wording and how FSCA differs from a US recall.

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