News: New guidance on remanufacturing of single-use medical devices
The UK's MHRA has produced new guidance in response to an industry desire to introduce remanufactured single-use products into the UK market.
Wednesday, 13th July 2016
The UK's Medicines and Healthcare products Regulatory Agency (MHRA) has produced new guidance in response to an industry desire to introduce remanufactured single-use products into the UK market. This is an important milestone for remanufacturing of medical devices in the UK.
The main points of the guidance are:
- Single-use devices may be re-manufactured for use in the UK. However, the remanufacturer, prior to placing their device on the UK market or to putting it into service, should meet all relevant criteria under the appropriate medical devices directive and place a CE mark on their product to declare conformity with that directive.
- The re-manufacturer accepts all liabilities and obligations for the re-manufacturing of the single-use device. The intended use of the re-manufactured device should not differ from the intended use of the original product.
- The supply of a particular re-manufactured SUD should be through a closed loop contract between the re-manufacturer and the healthcare institution (e.g. hospital, clinic). At no time should a re-manufacturer or healthcare institution sell or provide a re-manufactured SUD to any other third party.
- A re-manufactured single-use device should only be used on an individual patient during a single procedure and after that use the SUD should be returned to the contracted re-manufacturer.
- The packaging or device must have the specified symbol, which means do not reuse/use only once/single-use only.