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IVDR Essentials

Name: IVDR Essentials
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Placing in vitro diagnostics on the EU market: classification, Notified Body scope, performance evaluation, and post-market performance follow-up.

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1

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 regulation that replaced IVDD and pulled ~85% of IVDs under Notified Body oversight.
2

Regulatory

IVDR Risk Classes A–D

EU IVDR's risk-based classification: Class A (lowest) to Class D (highest).

Why this term here: A / B / C / D risk classes and the 7 rules that assign them.
3

Market Segments

Companion Diagnostic(CDx)

IVD that identifies patients who will benefit from a specific drug.

Why this term here: CDx is explicitly Class C: know the rule before you build one.
4

Regulatory

CE Mark

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

Why this term here: The market-access outcome every IVDR conformity assessment aims at.
5

Regulatory

Notified Body(NB)

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

Why this term here: Now involved in almost every IVD; scope must be verified in NANDO.
6

Regulatory

General Safety and Performance Requirements(GSPRs)

Annex I requirements under EU MDR/IVDR that every device must demonstrate it meets.

Why this term here: General Safety and Performance Requirements: the checklist Notified Bodies audit against.
7

Clinical & Trials

Clinical Evaluation Plan(CEP)

EU MDR document that defines the scope, methods, and acceptance criteria for the clinical evaluation that will be reported in the Clinical Evaluation Report (CER).

Why this term here: For IVDs this becomes the Performance Evaluation Plan under IVDR Annex XIII.
8

Post-Market

Post-Market Performance Follow-up(PMPF)

IVDR equivalent of PMCF - ongoing collection of performance data for in vitro diagnostics.

Why this term here: Post-Market Performance Follow-up: the IVDR analogue of MDR's PMCF.
9

Post-Market

PSUR (IVDR Specific)

Periodic Safety Update Report obligations for IVDs under EU IVDR Article 81.

Why this term here: Periodic safety report cadence differs by class; know your obligations.
10

Regulatory

EUDAMED

European Database on Medical Devices.

Why this term here: The EU database where UDI, actors, and vigilance data are registered.
11

Manufacturing

UDI-DI vs. UDI-PI

Static device identifier (DI) vs. dynamic production identifier (PI) within a UDI.

Why this term here: IVD-specific UDI attributes plus the standard Device / Production Identifier structure.
12

Post-Market

Medical Device Vigilance

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

Why this term here: Reporting serious incidents and FSCAs to Competent Authorities.
13

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: the regulated recall/notice mechanism in EU.

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IVDR Essentials

EU In Vitro Diagnostic Regulation(IVDR)

IVDR Risk Classes A–D

Companion Diagnostic(CDx)

CE Mark

Notified Body(NB)

General Safety and Performance Requirements(GSPRs)

Clinical Evaluation Plan(CEP)

Post-Market Performance Follow-up(PMPF)

PSUR (IVDR Specific)

EUDAMED

UDI-DI vs. UDI-PI

Medical Device Vigilance

Field Safety Corrective Action(FSCA)