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Erica Conway, PhD

Vice President, IVD Regulatory Affairs - Europe
MCRA

Dr. Conway has over 20 years of regulatory affairs and quality assurance experience, primarily within In Vitro Diagnostic (IVD) medical devices. Dr. Conway joined MCRA in Aug-2022 as VP IVD Regulatory Affairs - Europe. Prior to joining MCRA, she was the Head of IVD Notified Body (NB) at BSI Notified Body. At BSI, Dr. Conway was pivotal in the implementation of the IVD Regulation (IVDR, (EU) 2017/246) and the successful designations of both the UK and the Netherlands organizations to the IVDR. Dr. Conway represented IVD Notified Bodies on behalf of Team NB/NBCG-Med at MDCG IVD Working group meetings, where she contributed to the development of IVD MDCG guidance, as well as representing NBs in meetings for the development of the Companion Diagnostics consultation process as well as meetings with agency stakeholders on procedures for Class D IVDs under IVDR. In addition, she represented BSI at agency and government meetings in relation to the SARS-CoV-2 pandemic.

Dr. Conway’s industrial experience started in the regulation of pharmaceuticals before moving into clinical trials for medicinal products for a CRO. Dr. Conway moved into the field of IVD medical devices for a diagnostics company before becoming an independent consultant, working within the IVD and medical device fields. Dr. Conway joined BSI in 2014 as a Technical Specialist/Scheme Manager in the IVD medical devices team before assuming the role of Global Head of the IVD Team in 2016, leading the IVD Technical team for operational delivery of Technical Documentation assessments and expanding the team to meet the increased resource demands under the IVDR. Her role also included independent final decision making. Dr. Conway moved into the position of Head of IVD NB, where she was responsible for the overall compliance of the NB (and UK Approved Body) for certification of IVDs.

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