As healthcare moves towards a more proactive form of prescribing that aims to “detect and contrast” early on, this very simple definition of IVDs seems inadequate, suggests Jonathan Ripley, IVD and MD Consulting Services Director at IMed Consultancy.
Instead, these tools are recognised as playing a key role in protecting both individuals and society at large; early intervention results in lower treatment costs for health systems, can prevent diseases from becoming chronic and subsequently improve medical resources and budgets.
Arguably, public awareness of IVDs and the appreciation of their importance have never been higher. The COVID-19 pandemic introduced huge swathes of the public to the practicality of testing for early diagnosis.
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 (NHST&T) spent £10.4 billion on IVD testing in 2020 and 2021, up from £850 million in 2017, whereas Denmark spent 0.5% of its GDP on testing in 2021.1,2
Post-pandemic, the hard truth is that national health services have been left with depleted staff resources and long waiting lists for surgeries that, in many cases, are long overdue.
The impact of the pandemic led to a slowdown in treatment and diagnosis of diseases, with the result that patients that could have been treated with medication and therapy may now require longer treatment if not even surgery.
The need for continual IVD development and access to approved devices is clear. However, the introduction of new regulation throughout the EU and the UK poses something of a challenge for manufacturers and risks putting the brakes on IVD progress and acceleration.
On the one hand, the continual scrutiny and adaptation of regulation governing IVD development can be regarded as positive; it acknowledges that such devices are front and centre of health industry thinking and crucial to a robust healthcare system.
On the other hand, continual tinkering can leave manufacturers frustrated and confused — slowing the advancement of innovation. So, what’s the current picture?
The European Union’s approach to IVDs
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.
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, in fact, rests on meeting certain conditions, including having applied to a Notified Body at least 2 years before the compliance date.
As of today, there are only 12 appointed Notified Bodies for IVDs in Europe, so ensuring that one of these takes on a new device may prove difficult.
Estimates suggest that the entire certification process could take 18–24 months, depending on risk class, status and maturity of the technical documentation and quality management system (QMS), as well as the availability of a Notified Body.
IVDs in the United Kingdom
Early diagnosis is a topical theme for UK industry experts and government departments.
In the latest bid to spot disease before it becomes more complex and expensive to treat, the NHS has recently announced a £21 million fund that will be used to provide NHS staff with access to artificial intelligence (AI) technology to diagnose and treat patients more quickly.3
This move resonates with government plans to make the UK the global home of medical technology and a breeding ground for innovation (as set out in the Medical Technology Strategy).
For the time being, while the MHRA is increasing its engagement with the sector and industry bodies (BIVDA, ABHI, etc.), the UK government announced that it will indefinitely recognise the EU’s CE (Conformité Européenne) mark with respect to a range of manufactured goods placed on the UK market — a significant reversal of policy.
Previously, post-Brexit, the UK planned to phase out the CE mark and replace it with its own UKCA mark.
As of now, however, the indefinite extension of CE mark recognition does not cover medical devices nor IVDs, further complicating matters for IVD manufacturers.
The MHRA confirmed this position in a follow-up announcement and restated its existing plan to recognise 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.
In this complex international scenario, with constant changes and pushback, IVD manufacturers are struggling to keep up with the latest news and developments.
In these circumstances, the role of the regulatory consultancy takes on an even more critical importance in informing, advising and supporting so that devices can be safely commercialised in the shortest time possible.
Cutting down time-to-market grants national health services speedy access to a range of IVDs to help catch disease at the early stages, enabling treatment with drugs or minor procedures that are not particularly expensive and are minimally invasive for patients.
In short, early intervention delivers major benefits further down the line, with health service budgets being protected and patients receiving optimal care.
References
- www.nao.org.uk/reports/test-and-trace-in-england-progress-update/.
- www.bloomberg.com/news/articles/2022-06-16/denmark-spent-0-5-of-its-gdp-on-covid-19-testing-last-year?embedded-checkout=true.
- https://www.gov.uk/government/news/21-million-to-roll-out-artificial-intelligence-across-the-nhs.
