In-Vitro Diagnostics

IVD Consultancy

The size and complexity of the in-vitro diagnostic (IVD) market has been increasing in recent years due to numerous technological advancements such as in companion diagnostics and artificial intelligence. As the field has developed there have been significant changes in regulation in Europe, USA and elsewhere.

A recent example is the change in European regulation from the in vitro diagnostics device directive (IVDD, 98/79/EC) to the IVD device regulations (IVDR, (EU) 2017/746), increasing the challenges for CE mark approval of new IVD products and requiring assessment by a notified body for many existing products, often for the first time. In the USA, FDA prerequisites for IVD 510k approval have also increased recently and will continue to do so, for example with the FDA’s plans to commence scrutinising laboratory developed tests (LDTs).

Insight Regulatory have a wealth of IVD consultancy experience in the development and regulatory conformity of IVDs across the globe, including FDA dual 510(k)/CLIA waiver, EU CE Mark and UKCA approvals. As we’re a small consultancy, you will deal directly with the principals from the start, bypassing “business development” barriers.

We cover the gamut from an intelligence-driven strategy through development,submission and approval, to expanding territories and ensuring continued approval (figure 1).

A well-researched strategy is arguably the single most important element. We can work with you as a single source for regulatory affairs, or we can help with a single specific area where you need added expert resource.

IVDR transition

Due to the scale of the changes imposed by the IVDR, it is important for manufacturers to have in place a detailed plan which lays out exactly what work is required to maintain compliance and not jeopardise future sales. We use our expertise in IVD regulatory requirements to provide a comprehensive scheme to help you to transition to the new IVDR.

Regional Expansion - Global Registrations

Regional expansion brings multiple registrations, communication with third parties and possibly translated material. This resource drain needs to be handled in an efficient way. We have recent experience working on registrations in Australia, Canada, China, Japan, India, Brazil, across the Middle East and others, often working with in-country representatives.