MHRA Releases Guidance on Remanufacturing Single-Use Devices

Devicemakers in the UK that remanufacture single-use devices must accept all the obligations and liabilities that an original manufacturer would face, the regulator said.

The UK’s Medicines & Healthcare products Regulatory Agency issued its first formal guidance on remanufacturing single-use devices; however, it notes that the medical device directives “do not explicitly permit remanufacturing or reprocessing.”

Although single-use devices may be manufactured in the UK, the remanufacturer must ensure that the intended use of the device is the same as the original product.