UK needs to sharpen its act on home-brew guidance
This article was originally published in Clinica
The UK's Medicines and Healthcare products Regulatory Agency (MHRA) has acknowledged that there are still some shortcomings in its latest guidance to manufacturers on the modification of IVDs purchased from a third party, including when these are so altered that they may be considered as an entirely new product - as "home-brew" manufacture. It is planning to provide additional guidance to IVD users.
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