Re-Manufacturing of Single-USe Devices introduced by the MHRA

The MHRA has released guidance on the re-manufacturing of single-use medical devices.

A single-use device is used on an individual patient during a single procedure and then discarded. Single-use devices will have the following symbol on the device or packaging.

Single-use device

Re-manufacturing (of single-use devices) is different to reprocessing and is where a company obtains a CE mark for the re-manufacturing of single-use devices. Prior to placing on the market or putting into service, the device will be cleaned, disinfected and sterilised and be tested against the re-manufacturer’s specifications to ensure the single-use continues to operate safely and as intended.

Read the full article on RAPS or read the MHRA guidance here.

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Published on 12. July 2016 in News UK