OREANDA-NEWS. July 21, 2015. 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 2 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Following the review, MHRA has developed a draft guidance document which clarifies MHRA’s position on re-manufacturing SUDs and expectations around their use for:

  • healthcare professionals
  • manufacturers
  • any provider of medical devices

The draft document is now available for review and MHRA are looking for comments through the survey below.

Single-use medical devices: UK guidance on re-manufacturing - draft (PDF, 148KB, 10 pages)

Survey on the guidance on the re-manufacture of single use devices

If you have any comments please complete the survey by 1 September 2015. You feedback is extremely valuable to us.

We anticipate that the final guidance will be produced by the end of 2015.