MHRA Publishes New Guidance On Remanufacturing Of Single-Use Devices

On July 5, 2016, the MHRA published new guidance on the remanufacturing of single-use devices ("SUDs") and expectations for their use. This follows a three-year review by the MHRA of remanufacturers in which the MHRA assessed the technical, regulatory, and clinical processes of such remanufacturers. The key points of the guidance are:

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