MDRTraining
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MDR & IVDR

Regulatory Foundations

Understand the EU regulatory landscape for medical devices — who the key players are, what the regulations require, and how MDR and IVDR fit together.

  1. 1

    The EU Regulatory Landscape

    How medical device regulation evolved from the directives (MDD/IVDD) to the current MDR/IVDR framework, and why it matters.

    12 min
  2. 2

    Scope and Key Definitions

    What counts as a medical device under Article 2, borderline products, and the scope boundaries of MDR and IVDR.

    15 minRequires: The EU Regulatory Landscape
  3. 3

    Economic Operators and Their Obligations

    Manufacturers, authorised representatives, importers, and distributors — who does what under the MDR.

    14 minRequires: Scope and Key Definitions
  4. 4

    Notified Bodies and Competent Authorities

    The role of notified bodies in conformity assessment, how they are designated, and how competent authorities oversee the system.

    10 minRequires: Economic Operators and Their Obligations