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

EU Medical Devices Regulation (MDR 2017/745) MDR-Art.17_18: Single-use device reprocessing and implant card (Articles 17-18)

Article 17 permits the reprocessing of single-use devices only where authorised by national law and subject to Article 17(2) safe-handling conditions; the reprocessor is considered to be the manufacturer of the reprocessed device. Article 18 requires manufacturers of implantable devices to provide an implant card together with information to be supplied to the patient. The card contains: device identifier + manufacturer identity + clinical / safety information + UDI + post-implant patient instructions.

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

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