Guidance

Single-use medical devices

UK guidance on re-manufacturing of Single-use medical devices.

• From: Medicines and Healthcare products Regulatory Agency
• Published: 5 July 2016

Documents

re-manufacture of Single-use devices

PDF, 370 KB, 11 pages

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Details

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
• manufacturers

Published 5 July 2016