MHRA Guideline on Re-Manufacturing of Single-Use Medical Devices
Recommendation
11/12 February 2025
Heidelberg, Germany
Medicinal Products/Drugs meet Medical Devices
Register now for ECA's GMP Newsletter
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.
Related GMP News
08.10.2024EMA updates Question and Answer Document on Combination Products
08.10.2024Transparency Guidelines for Medical Devices with Artificial Intelligence
12.09.2024Notified Body Survey on Certificates & Applications under the Medical Devices/IVD Regulation
12.09.2024Statistical Methods are also important for Medical Devices
12.09.2024FDA Draft Guidance on Human Factor Studies
18.01.2024Notified Body Survey on Certificates and Applications under the Medical Devices/IVD Regulation