by Vibha Sharma

New guidance from the UK MHRA sets out the conditions under which re-manufacturing of single-use devices is allowed; new CE mark needed and re-manufacturer assumes legal responsibility.

The UK Medicines and Healthcare products Regulatory Agency has issued new guidelines that open the door to re-manufacturers of single-use devices (SUDs) by setting out the conditions under which the activity is allowed.

The final guidance clarifies that re-manufacturing is different from re-processing/refurbishment; the MHRA does not allow SUD re-processing. (Also see “UK MHRA consults on single-use device remanufacturing” – Medtech Insight, 23 Jul, 2015.)

The key difference between a re-processor and re-manufacturer is that the latter needs to have a CE mark to bring a product to the market. This point is made in the guideline. In addition, the guideline states that the re-manufacturer would assume the full legal responsibility and liability for the re-manufactured device…

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