Devices & Diagnostics Letter
July 23, 2012
| Vol.
39 No.
29
UK Offers Guidance for Notified Bodies on Review of IFUs for Home Test Kits
Makers of home use medical test kits must be able to demonstrate that they can be properly used by people who lack specialized training, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) says in new guidance for notified bodies.
This article is viewable by subscribers only. To view this article, please select an option below.
|