EU In Vitro Diagnostic Medical Devices Regulation (IVDR)
IVDR - Classification + Conformity Assessment (Ch V)

EU In Vitro Diagnostic Medical Devices Regulation (IVDR) IVDR-Art.51_52_53_54_55: Certificates of conformity, electronic system, voluntary change of NB, derogations, certificates of free sale (Articles 51-55)

Article 51 governs certificates of conformity issued by NBs (validity max 5 years, may be subject to conditions, suspended/withdrawn/restricted on non-compliance). Article 52 establishes the electronic system on NBs + certificates. Article 53 governs voluntary change of NB by the manufacturer. Article 54 allows derogations from conformity-assessment procedures by a competent authority in the interest of public health, patient safety or health, or to enable access to clinical trial in an emergency. Article 55 governs certificates of free sale issued by competent authorities for exports.

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

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