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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 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, all with Dr Erica Conway.
Dr Conway has over twenty years of regulatory affairs and quality assurance experience, primarily within In Vitro Diagnostic (IVD) medical device field. Dr Conway joined MCRA, a consultancy company, in Aug-2022 as VP IVD Regulatory Affairs. Prior to MCRA, Dr Conway’s first industrial experience started in the regulation of pharmaceuticals before moving into clinical trials for medicinal products. Dr. Conway moved into the field of IVD medical devices in 2006 for a major diagnostics manufacturer, before becoming an independent consultant, working within the IVD and medical device fields on aspects of regulatory affairs and quality management systems. Latterly, Dr Conway spent 8.5 years as Global Head of IVDs and the Head of IVD Notified Body (NB) at the British Standard Institution (BSI). 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 has a Bachelor of Science (BSc Hons) in Physiology from the University of Sheffield, U.K. and Doctorate of Philosophy (PhD) specializing in neurophysiology from the University of Bristol, UK. Dr Conway did a short post-Doctoral position at the University of Cambridge before entering industry.
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.