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:
- SUDs may be remanufactured for use in the UK. However, the remanufacturer, prior to placing a device in the UK market or to putting it into service, should meet all relevant criteria under the appropriate medical devices directive and place a CE mark on the product to declare conformity with that directive.
- The remanufacturer accepts all liabilities and obligations for the remanufacturing of the SUD. The intended use of the remanufactured device should not differ from the intended use of the original product.
- The supply of a particular remanufactured SUD should be through a closed-loop contract between the remanufacturer and the health care institution (e.g., hospital, clinic). At no time should a remanufacturer or health care institution sell or provide a remanufactured SUD to any other third party.
- A remanufactured SUD should be used only on an individual patient during a single procedure; after that use, the SUD should be returned to the contracted remanufacturer.
- The packaging or device must have a specific symbol indicating "Do not reuse/Use only once/Single-use only."
This document is aimed at all companies that remanufacture medical devices that were originally "single use"; notified bodies; UK trade associations; all providers of medical devices, e.g., NHS Supply Chain, remanufacturers; chief executives and managers of institutions where medical devices are used; and health care institutions and professionals who use medical devices.