EU In Vitro Diagnostic Medical Devices Regulation (IVDR)
IVDR - Making Available + Economic Operators (Ch II)

EU In Vitro Diagnostic Medical Devices Regulation (IVDR) IVDR-Art.16: Cases in which obligations of manufacturers apply to others (Article 16)

Article 16 provides that distributors / importers / other natural or legal persons are considered to be the manufacturer + assume the Article 10 obligations where: (a) they make available a device under their own name / trade mark / trademark (rebranding); (b) they change the intended purpose of a device already placed on the market; (c) they modify a device already placed on the market in such a way that compliance may be affected. Article 16(2) creates exceptions for natural-language translation + repackaging if Article 16(4) conditions met (notify manufacturer + competent authority 28 days in advance, QMS aspects in place).

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