Stephen Lee

Director of Diagnostics & Digital Regulation
ABHI, United Kingdom

Stephen is Director of Diagnostics & Digital Regulation at ABHI – the UK’s industry association for health technology
After training as a Biomedical Scientist in hospital pathology, Stephen worked as a company microbiologist until 1996 when he joined the medical device regulator now known as the UK Medicines & Healthcare Products Regulatory Agency – MHRA – most recently as senior policy manager focussing on the implementation of the new regulations for in vitro diagnostic medical devices

Stephen was the chair of the European Commission’s IVD working group. This group is responsible for implementing IVD specific issues related to the new regulations including classification, performance evaluation, Common Specifications and advice and guidance on IVD regulatory issues.

Presentation(s):

• UKCA & Market Developments

  Wednesday, September 18, 2024
  2:15 PM - 3:15 PM PDT

• International Harmonization & Regulator Forum

  Thursday, September 19, 2024
  4:30 PM - 5:30 PM PDT