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IVD Development Investors: [Too] Great Expectations?

“Take nothing on its looks; take everything on evidence. There’s no better rule.”

-Charles Dickens, Great Expectations

This week at IVDeology, we have been speaking to many IVD (in vitro diagnostic) manufacturers regarding the expectations from the investors on the timeline for obtaining a CE mark for their devices. For many SMEs, the funding opportunity is associated with the timelines for delivery. While it is true that placing devices on the EU market with a CE mark has been reasonably straight forward under the existing IVD Directive 98/79/EC, the days of ‘quick’ market access are coming to an end. 

From May 2022 (is it really only a few months away?) IVDs placed on the market in Europe will be required to meet the requirements of the IVD Regulation 2017/746/EU. With this change in regulation, the need to demonstrate safety and compliance is based on evidence, collected in most part before the device is placed on market, The need to establish scientific validity, analytical performance and clinical performance is centric to the device performance evaluation requirements. Collecting such data takes time, money and resource. Investors need to understand that this is an absolute requirement, and cutting corners as part of the design and development process will putt the overall project design process at risk.

View our video on the importance of IVDs

The establishment of a clear regulatory strategy, within a well constructed quality management system is the best way to achieve CE marking success. The more investors reassess their expectations by understand these principles, and the mechanisms required to achieve the compliance, the greater the change of placing safe and effective devices on the market.

IVDeology provide consultancy, training and compliance services to support IVD CE marking, UKCA and RoW registrations. Contact me for more information [email protected]

Charles Dickens spent some of his childhood years in Chatham, Kent. His father John, worked as a clark for the Royal Navy at the Historic Dockyard in Chatham, were IVDeology HQ is located. 

-Stuart Angell, Managing Director, IVDeology Ltd