Dr Liz Harrison

New European Regulations for CE Marking of IVD Devices


Liz Harrison has an undergraduate degree in Biochemistry with Applied Molecular Biology. After completing a PhD in Molecular Diagnostics, she moved into post-doctoral research focussing on diagnosis of sepsis and respiratory disease. A move into industry followed in 2010 to work on the design and development of platforms for point-of-care genetic testing and infectious disease diagnostics. In 2014 Liz joined BSI - an EU Notified Body for the CE marking of high and medium risk IVDs. Notified Bodies are currently preparing for the new IVD Regulations which will require up to 95% of IVDs to be reviewed by a Notified Body before being placed on the EU market from May 2022.