MHRA Guidance on the Re-Manufacture of Single Use Devices

A number of manufacturers who have a CE mark for a re-manufactured single-use device (SUD) want to put them on the market in the UK.

Over the last 3 years, MHRA has conducted a detailed review of re-manufacturers, assessing their technical, regulatory and clinical processes.

Following this review, MHRA has developed a guidance document on the re-manufacture of single use devices and expectations around their use.

To read more about this, please click here.

Tagged with

Published on 5. July 2016 in News UK