MHRA Guideline on Re-Manufacturing of Single-Use Medical Devices

Recommendation

10/11 December 2025
Berlin, Germany

CMO Oversight - Quality Oversight of Pharmaceutical Contract Manufacturing Organisations
What MAHs and Virtual Companies need to know

Last year the MHRA published a 11-page guidance about the re-manufacturing of single-use medical devices (SUDs). Although the guidance is only valid for the UK, its content is interesting.

Re-manufacturing of SUDs is allowed in the UK but the re-manufacturer should meet all relevant criteria under the current medical device directives prior to placing the device on the market. This should be verified regarding performance and safety by a notified body. That means that the intended use of the medical device is unchanged. A close loop contract should exist between re-manufacturers and health care institutions (e.g. hospital). Class I devices are exluded from re-manufacturing. The packaging or device must have the symbol for single-use only on it.

Very interesting is the 2,5 page glossary which explains among others the different terms reprocessing, fully refurbishing, re-use, single-use.

You can download the guidance on the MHRA website.