Blog Post | Focus on Regulation | 4 April 2017

The MHRA issues new guidance concerning own brand labelling or "virtual manufacturing"

On 29 March 2017, the UK Medicines and Healthcare products Regulatory Agency (MHRA) published a new guidance (hereafter “Guidance“) concerning the Own Brand Labelling of medical devices in the United Kingdom. The Guidance, which is expected to have substantial consequences for the current arrangements between Own Brand Labellers (OBL) and “Original Equipment Manufacturers” (OEM), is intended to replace the MHRA guidance titled “Own Brand Labelling and Rented Products, Bulletin No. 19” last amended in June 2011.

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