IVDR

In Vitro Diagnostic Medical Devices Regulation (IVDR)

This course provides a practical and sequential understanding of compliance obligations under the In Vitro Diagnostic Medical Devices Regulation (IVDR), Regulation (EU) 2017/746. It breaks down the complex lifecycle into four actionable phases: Classification, Conformity, Traceability, and Sustained Compliance. The material emphasizes that rigorous adherence to these rules is mandatory for legal market access and for ensuring product quality and safety across the European Economic Area (EEA).

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CEU Credits: 0.1
Course Code: ELM-348
Duration: 20 mins
Skill Level: Intermediate
Language: English
Final Exam: Yes
Certification: Yes
Version: v1.0
Effective Date: 10/24/2025

Curriculum for this course

The IVDR
Key definitions
From A to D
Impact on teams
Making claims
Technical documentation
The Performance Evaluation (PE)
Conformity assessment
Economic operator roles
Registration
Unique Device Identification (UDI)
The Summary of Safety and Performance (SSP)
Devices for Special Purposes: Exemptions and Rules
The PMS system and plan
Reporting incidents
Field safety corrective actions
Trend reporting
The Periodic Safety Update Report (PSUR)
Summary
Test Your Knowledge!
v1.0 Course released on 01/27/2026

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