The early screening imperative

by | Apr 4, 2024 | IMed Consultancy, IVD, UK, UKRP | 0 comments

IVD blog 1

The early screening imperative:

the UK regulatory landscape for IVDs

In the aftermath of the Covid-19 pandemic many national health services have been 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, 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.

IVDs, covering a broad range of areas from pregnancy tests to Covid-19 swabs, play a critical role in supporting the healthcare system with early diagnosis. . 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 could have a huge impact on patients as well as health system budgets.

In addition to better outcomes, early intervention also results in lower treatment costs for health systems, making it imperative for national and international institutions to do as much as possible to improve access to IVDs. The introduction of a new regulatory framework in the UK, alongside IVDR – is 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. In the UK, NHS Test and Trace spent £10.4 billion on IVD testing in 2020 and 2021, up from £850 million in 2017. 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 regulatory picture

Regulation is shifting in the UK. On 1st August 2023, in a significant reversal of policy, the UK Government announced that it will indefinitely recognize the EU’s Conformité Européenne or CE mark with respect to a range of manufactured goods placed on the UK market. Previously, post-Brexit, the UK planned to phase out the CE mark and replace it with its own UKCA mark.

However, further confusion lies in the fact that the indefinite extension of CE mark recognition does not cover medical devices nor IVDs.  The MHRA confirmed this position in a follow-up announcement and restated its existing plan to recognize the CE mark for medical devices and IVDs until 2028 and 2030 respectively, at which point manufacturers will be required to use the UKCA mark.  A further update is expected in due course. Manufacturers are left wondering what the conformity assessment picture will look like over the next few years.

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 devices 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.

For more on this issue, read our white paper, available on our Resources page, or contact the team at IMed Consultancy for deeper insight into the regulatory scenarios governing IVD development: hello@imedconsultancy.com.

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

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