European Medicines Agency
MGI Receives CE Mark, Regulatory Clearance in Asia-Pacific Countries for Several Sequencers
The clearances pave the way to clinical applications for three of MGI's instruments but the BGI subsidiary faces legal challenges from Illumina in Europe and the US.
EMA Issues Guidance Related to New European Medical Device, IVD Regulations
The guidance is the first of several that will cover the new medical device and in vitro diagnostic regulations, which are set to come into force by 2020 and 2022, respectively.