MHRA: Guidance for notified bodies on the regulation of IVDs for self-testing
12.07.2012
This guidance is intended to support the notified body assessment and although it is not aimed directly at manufacturers of self-tests, notified bodies may wish to share this guidance with prospective clients in order to demonstrate regulatory expectations
The source of the news: http://www.mhra.gov.uk/home/groups/dts-bs/documents/websiteresources/con171951.pdf
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