The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) on Tuesday said that single-use medical devices may be re-manufactured for use in the UK, though the remanufacturers should meet all relevant criteria under the appropriate device directives and place a CE mark on their product.
The shift to allow such re-manufacturing comes with new guidance from MHRA, which notes that the re-manufacturing of single-use devices and similar processes have existed outside of the UK for a number of years and the regulator is aware of “a number of companies” that wish to introduce such processes into the UK.
In addition to meeting the relevant directive's criteria and obtianing the CE marking, the new guidance makes clear that a re-manufacturer "should confirm validity and surety of all manufacturing processes and accepts all liabilities and obligations for the re-manufactured [single-use device]. We expect any healthcare institution that chooses to use re-manufactured single-use medical devices to have a contract with a specific re-manufacturer,” MHRA says, noting that all Class I devices are excluded from this policy as the regulator “considers that class I products should not be re-manufactured as there would be no external or independent assessment of CE mark compliance.”
The re-manufacturer also must accept all liabilities and obligations for the re-manufacturing of the single-use device and the intended use of the re-manufactured device should not differ from the intended use of the original product, MHRA adds.
As far as the supply of a particular re-manufactured single-use device, it should be through "a closed loop contract between the re-manufacturer and the healthcare institution (e.g. hospital, clinic)," MHRA adds, noting that at “no time should a re-manufacturer or healthcare institution sell or provide a re-manufactured [single-use device] to any other third party.”
MHRA is also requiring that the packaging or device include the following symbol, which means do not reuse/use only once/single-use only.
The notified body also should verify that the re-manufactured single-use device clearly meets all appropriate criteria of the relevant device directive in terms of performance and safety. The notified body should further “confirm validity and surety of all manufacturing processes (design processes where applicable), and that they meet the regulatory requirements pre and postmarket. Through use of clinical and technical testing and supporting evidence the re-manufacturer shall establish the maximum number of re-manufacturing cycles to which the device will be subjected while maintaining all device functionality, performance and safety parameters.”
And it is the re-manufacturer’s responsibility to track the number of times the device is remanufactured and reused, MHRA says, noting that following the first use of the single-use device, the original equipment manufacturer “is no longer responsible for the product if it is re-manufactured.”
When the re-manufactured device no longer meets specification, or the defined number of remanufacturing cycles has been reached, MHRA says the device shall be disposed of by the remanufacturer or healthcare institution.
“The re-manufacturer is responsible for providing, to the healthcare facility, all appropriate containers or returns packaging,” according to the guidance. “The re-manufacturer’s responsibility for the device starts when the healthcare facility places the used product into the re-manufacturer’s container or returns package, which would be sited at the healthcare facility.”Single-use medical devices: UK guidance on re-manufacturing