EU Medical Devices Regulation (MDR 2017/745)
MDR - Making Available + Economic Operators (Ch II)

EU Medical Devices Regulation (MDR 2017/745) MDR-Art.16: Cases where manufacturer obligations apply to others (Article 16)

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

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

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