Re-manufacture of single use devices: comments on draft guidance
MHRA is seeking your views on draft guidance on the re-manufacture of single use devices.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.
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Following the review, MHRA has developed a draft guidance document on re-manufacturing SUDs and expectations around their use for:
- healthcare professionals
- any provider of medical devices
The draft document is now available for review and MHRA would like your comments, which will be taken into account when finalising the guidance.
Single-use medical devices: UK guidance on re-manufacturing - draft (PDF, 148KB, 10 pages)
You can send your comments to firstname.lastname@example.org. Your views are extremely valuable to us. The closing dates for comments is 1 September 2015.
We anticipate that the final guidance will be produced by the end of 2015.
Published: 20 July 2015