Article 17 of the European Medical Devices Regulation 2017/745 (MDR) covers reprocessing of single-use medical devices. It indicates that reprocessing of single-use devices is only permitted if specifically allowed by national law in a Member State. It also sets down requirements when such reprocessing is permitted, unless the Member State sets out stricter national requirements.
Organizations that reprocess single-use devices for further use are considered to be the manufacturer of the reprocessed device and assume the obligations of the manufacturer in Article 10 of the MDR. The name and address of the original manufacturer of the single-use device cannot appear on the label but is to be indicated in the instructions for use of the reprocessed device…
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