EU In Vitro Diagnostic Medical Devices Regulation (IVDR) IVDR-Art.11_12: Authorised representative and change of authorised representative (Articles 11-12)

Article 11 requires a non-EU manufacturer to designate, by written mandate, a single authorised representative established in the Union. The authorised representative is responsible for ensuring (in cooperation with the manufacturer) Article 11(3) tasks (technical documentation availability, registration, cooperation with competent authorities). Article 12 governs the orderly change of authorised representative.

Other controls in IVDR - Making Available + Economic Operators (Ch II)

IVDR-Art.10 General obligations of manufacturers (Article 10)
IVDR-Art.13_14 Obligations of importers and distributors (Articles 13-14)
IVDR-Art.15 Person Responsible for Regulatory Compliance (Article 15)
IVDR-Art.16 Cases in which obligations of manufacturers apply to others (Article 16)
IVDR-Art.5_6_7 Placing on the market, distance sales and claims (Articles 5-7)
IVDR-Art.8_9 Harmonised standards and common specifications (Articles 8-9)

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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 endpoint All EU In Vitro Diagnostic Medical Devices Regulation (IVDR) controls