The British regulatory authority MHRA has recently issued the “Virtual Manufacturing replaces Own Brand Labelling for medical device manufacturers” guidance.
This new guidance intends to define the Virtual Manufacturer requirements and obligations, that is a natural or legal person who places Medical Devices on the market under his name despite not undertaking the design or manufacture of the medical device itself.
As of September 1, 2017, the MHRA will consider Virtual Manufacturers as actual manufacturers and they will permanently replace the Own Brand Labelling (OBL).
The Virtual Manufacturer shall have the obligation to hold and maintain full technical documentation for any and all devices he places on the UK market, as well as the Original Equipment Manufacturers (OEM) contractual arrangements documentation.
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