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.
These companies have been re-manufacturing SUDs for a number of years and such devices are widely used in some countries. Over the last 3 years, MHRA has carried out a detailed review of re-manufacturers, assessing their technical, regulatory and clinical processes.
Following the review, MHRA has developed a guidance document on the
and expectations around their use for:
- healthcare professionals