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MDR

Conformity Assessment Pathways

Learn which conformity assessment route applies to each device class, and how to navigate Annexes IX through XI.

  1. 1

    Overview of Conformity Assessment

    The general framework and how the annexes relate to each other.

    12 minRequires: Classification Principles
  2. 2

    Class I Self-Declaration

    Annex IV pathway for Class I devices — what you can self-certify and what you cannot.

    10 minRequires: Overview of Conformity Assessment
  3. 3

    Class IIa and IIb Routes

    Annex IX, X, and XI options for mid-risk devices.

    15 minRequires: Overview of Conformity Assessment
  4. 4

    Class III Full Quality Assurance

    The most rigorous pathway: Annex IX with design dossier examination.

    14 minRequires: Overview of Conformity Assessment
  5. 5

    Choosing the Right Pathway

    Decision workshop — match device profiles to the optimal conformity assessment route.

    18 minRequires: Class I Self-Declaration, Class IIa and IIb Routes, Class III Full Quality Assurance