For a start-up or an early phase developer, there are many hurdles to overcome to get from a biomarker that appears clinically interesting, to an in vitro diagnostic (IVD) test that can then be placed on the market or offered to patients as a regulated product.
This presentation will take attendees through the regulatory journey, from early-stage discovery (feasibility) to the final stages of device certification in the EU and UK. This starts with the initial considerations of intended use, and what this means. An overview of the EU IVD Regulation (IVDR, (EU) 2017/746) will form the basis for outlining the regulatory considerations that are critical to getting a device to market. This includes the phases of design and development, under a quality management system, through analytical (verification) performance testing to clinical performance studies (validation). Following these stages, the focus will turn to the certification process, specifically what this entails for the EU and the UK.
In summary, there are key regulatory considerations and milestones that IVD test developers should be aware of and plan for, in order to achieve certification to place the test on the market and make it available to patients. This overview will be followed by a Q&A session and is presented by Dr Erica Conway.
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 August 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 organisations to the IVDR. Dr Conway represented IVD Notified Bodies on behalf of Team NB/NBCG-Med at MDCH 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.
Dr Conway has a Bachelor of Science (BSc Hons) in Physiology from the University of Sheffield and a Doctorate of Philosophy (PhD) specialising in neurophysiology from the University of Bristol. Dr Conway did a short post-Doctoral position at the University of Cambridge before entering industry.
SPARK Studio workshops and talks are designed for researchers, academics and aspiring entrepeneurs interested in therapeutics, medical devices and/or in vitro diagnostics development. We aim to support projects from concept and laboratory to clinic.
This SPARK The Midlands event is being delivered as part of Aston University's active involvement in the delivery of the West Midlands Health Tech Innovation Accelerator (WMHTIA). The WMHTIA is funded by the Department of Science, Innovation and Technology, in partnership with Innovate UK and the West Midlands Combined Authority.
For an enquiries, please email us at spark-uk@aston.ac.uk or visit www.sparkthemidlands.co.uk/contact
