The Medicine and Healthcare products Regulatory Agency (MHRA) is seeking feedback from the medical devices industry about an important imminent change relating to Own Brand Labelling.
There are two documents:
The key section of the guidance document is on page 5, ‘Responsibilities of the own brand labeller’. What it means is that the Own Brand Labeller now needs to hold a full technical file; in effect, become the ‘manufacturer’.
Some of the implications medical devices manufacturers need to consider:
Medical devices manufacturers are requested to disseminate this information and respond by Friday 13 May to email@example.com.