Medical Devices - Topics of Interest

Health institutions reprocessing single-use medical devices

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A health institution reprocessing single-use devices will have to comply with Article 17 of the MDR. The Regulation adds strict conditions for reprocessing of single-use medical devices, and places full product liability on the reprocessor. In addition, reprocessing may only take place when authorised under national law and in accordance with the provisions of the MDR. Some EU countries may have stricter provisions, or even ban reprocessing.