Navigating the path to IVD access and early intervention advantage

There is a pressing need for national and international institutions to do as much as possible to improve access to IVDs. Early diagnosis through the use of IVDs plays a critical role in patient outcomes and in supporting the healthcare system as a whole. Early interventions prevent chronicization of diseases, resulting in lower treatment costs for health systems and lessening the impact on resources and budgets. They also serve to provide patients with a better understanding of their condition, and how it might be managed.

The aftermath of the Covid-19 pandemic has left national health services battling surgery backlogs with depleted staff numbers. Preventing avoidable surgery through early diagnosis is of clear advantage. And yet the regulatory landscape is presenting challenges to IVD development at a time when healthcare systems are under enormous pressure.

In fact, regulatory changes represent both an opportunity to address the issue and a risk for approval bottlenecks in this critical area.

The EU route to IVD access

Since May 2022, regulatory change in the shape of the EU IVDR has placed IVD development and access in the EU under greater scrutiny, demanding more transparency across the process.

In January 2024, the European Commission released a proposal regarding the transitional provisions for certain legacy IVDs. This proposal is a response to figures showing that a high number of IVDs currently on the market have not yet managed to transition to the IVDR. Such devices would no longer be available by the end of current transition timelines.

The proposal seeks to provide manufacturers and notified bodies with additional time, under certain conditions, to complete applications and necessary conformity assessment procedures. The stated aim is to ensure patient care by improving the availability of these essential healthcare products, without compromising safety requirements.

The proposed extension is not a cue for manufacturers to relax their compliance activity. Most IVD devices will now require Notified Body review and approval, and potential delays should be considered – particularly in view of the fact that there are only 12 appointed Notified Bodies for IVDs in Europe. The recommendation is for manufacturers to consult with their respective Notified Body (where required) to evaluate potential issues related to currently approved devices, addressing any issues promptly to ensure a smooth transition to IVDR requirements.

Regulatory shift in the United Kingdom

Regulation is also 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, the UK’s post-Brexit strategy was to replace the CE mark with its own UKCA mark.

For IVD manufacturers, the picture is different still. The indefinite extension of CE mark recognition does not cover medical devices nor IVDs.  The MHRA has 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.

Given this regulatory turbulence, manufacturers can be forgiven for wondering if further change relating to device conformity is around the corner.

Clearly, fast-moving regulation in both the EU and the UK 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. Currently, manufacturers are having to spend an inordinate amount of time and resources just on keeping a hawk-eye on shifting regulatory demands. 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.

IVDs should no longer be regarded as mere devices for testing. By enabling early intervention, IVDs not only improve patient outcomes, they protect the entire healthcare system from drained resources and overspend. The benefits delivered by early detection are huge and long-lasting - the devices used to expediate this work must not be held up through red tape.

Jonathan Ripley

IVD and MD Consulting Services Director

Jonathan, IMed’s Consulting Services Director, initially started his career in pathology laboratories, before studying for a degree in Microbiology. Now, with 15 years’ experience in Quality Management gained in pharmaceuticals, Defence and In-Vitro Diagnostic Medical Devices, he amassed considerable expertise in managing systems certified to ISO9001:2015 and ISO13485:2016.

Jonathan’s experience in Regulatory Affairs has also seen him working with RT-PCR, Immunoassays and Immunochromatographic technologies, in addition to consulting and helping clients navigating global regulatory requirements; particularly in EU and US.

jonathan@imedconsultancy.com