EU In Vitro Diagnostic Medical Devices Regulation (IVDR)
IVDR - Notified Bodies (Ch IV)

EU In Vitro Diagnostic Medical Devices Regulation (IVDR) IVDR-Art.31_32_33: Notified bodies - authorities, requirements and subsidiaries (Articles 31-33)

What does IVDR-Art.31_32_33 require?

Article 31 requires Member States to designate authorities responsible for the assessment, designation, notification, monitoring + re-assessment of notified bodies (NBs). Article 32 sets the substantive requirements for NBs (organisational + competence + quality-management). Article 33 governs subsidiaries and subcontracting (NB retains full responsibility).

Maintained by Gerard BlokdykVerified against the published standard Control text last updated

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The graph holds this control, the 0 it maps to, and the evidence behind each claim, over MCP and REST.

MCP endpointAll EU In Vitro Diagnostic Medical Devices Regulation (IVDR) controls