Why a clear path to IVD development and access is critical to healthcare system support

by | May 17, 2024 | EU, IMed Consultancy, IVD, MDR

IVD blog 1

The role of IVDs in supporting the entire healthcare system through early diagnosis cannot be overstated. In very simple terms, IVDs are tests conducted on samples such as blood or tissue that have been taken from the human body. IVDs cover a broad range of areas, from pregnancy tests to Covid-19 swabs. The World Health Organization (WHO) reports that between 30% – 50% of human cancers are preventable[i] and several can be screened for using IVDs. Early diagnosis and treatment of often asymptomatic conditions such as type 2 diabetes, hypertension, and hyperlipidaemia is also made possible.

Early diagnosis plays a critical role in patient outcomes, ensuring patients understand how their symptoms will change over time and how this can be changed with treatment. Targeted interventions can also be started earlier, before potentially irreversible damage has occurred, helping to slow or reverse the disease process.

In addition to better patient outcomes, early intervention also results in lower treatment costs for health systems, helping to prevent surgery and the associated costs that go with these procedures and the consequent after-care. Resources are freed and budgetary pressures relieved.

Such considerations are particularly pressing in the aftermath of the Covid-19 pandemic, with many national health services left with depleted staff resources and long waiting lists for surgeries that, in many cases, are long overdue. The pandemic resulted in a two-year slow-down in treatment and diagnosis of diseases, leading to many conditions going undiagnosed or untreated during lockdown.

In this context, it is imperative for national and international institutions to do as much as possible to improve access to IVDs. However, regulatory upheaval  represents both an opportunity to address the issue and a risk for further bottlenecks in this device area.

Heightened awareness vs regulatory change

With some variation, levels of spending by governments on IVD testing during the pandemic were consistently higher across the board. Arguably, the interest and awareness of the benefits that IVDs can deliver through earlier testing has never been higher – the pandemic introduced the concept of IVD testing to a huge percentage of individuals. However, against this backdrop of increased awareness, a complex and changing regulatory field is serving to put the brakes on acceleration of IVD approval and access.

The EU regulatory picture

The regulatory landscape in Europe is experiencing revolutionary change with the introduction of the EU MDR and EU IVDR. This new regulation has applied since May 2022 and demands, among other things, greater transparency and scrutiny.

Within the EU IVDR, IVDs have been divided into four classes based on both their intended purpose and the inherent risks. In January 2024 the EU proposed an extension to the deadline to certify devices under the new IVDR classifications – with dates shifting to the end of 2027, the end of 2028 and the end of 2029 depending on the IVD classification required. This extension doesn’t mean that manufacturers should pause their compliance activity. Eligibility for any proposed extension rests on meeting certain conditions, including having applied to a Notified Body at least two years before the compliance date. As of today, there are in fact only 12 appointed Notified Bodies for IVDs in Europe, so ensuring that one of these Bodies takes on a new device is not an easy feat. Estimates suggest that the entire certification process could take up to 18-24 months, depending on risk class, status and maturity of the technical documentation and QMS, as well as the availability of a Notified Body.

As healthcare moves away from a “pill for all ills approach” and towards a more proactive form of prescribing that aims to “detect and contrast” early on, IVDs are no longer seen as simple tests but as tools to protect the healthcare system and society from a range of known and new pathogens.

Fast-moving regulation and lack of clarity makes this a difficult field for manufacturers to negotiate. It is not possible to increase use of IVDs in healthcare unless these are making their way through regulatory pathways steadily and successfully. In this complex international scenario, the role of the regulatory consultancy takes on critical importance in informing, advising and supporting IVD manufacturers so that their devices can be safely commercialised in the shortest time possible.

[i] World Health Organization. Preventing cancer. [Online].; [Cited 2020 Aug.15. Available from: https://www.who.int/activities/preventingcancer

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