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EU MDR Essentials

Name: EU MDR Essentials
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The European regulatory vocabulary for placing devices on the EU market.

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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

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

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

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

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

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

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

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

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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EU MDR Essentials

EU Medical Device Regulation(MDR)

EU In Vitro Diagnostic Regulation(IVDR)

CE Mark

Notified Body(NB)

EUDAMED

Unique Device Identification(UDI)

Periodic Safety Update Report(PSUR)

Medical Device Vigilance

Field Safety Corrective Action(FSCA)