The regulatory upheaval in the UK and EU, with the introduction of a new regulatory framework in the UK and the EU IVDR, represent both an opportunity and risk for bottlenecks.

Jonathan Ripley, IVD and MD Consulting Services Director

March 27, 2024

5 Min Read
Jonathan Ripley
Image courtesy of Jonathan Ripley

Early diagnosis plays a critical role in patient outcomes, from enabling rapid interventions to helping patients understand how their symptoms will change over time and how this can be altered with treatment. All these critical elements contribute to getting better faster or at least to helping slow or reverse the disease process. Early diagnosis and treatment can have a huge impact on both patient and health systems, especially in typically asymptomatic conditions such as type 2 diabetes, hypertension, and hyperlipidaemia. With oncology patients specifically, early diagnosis is closely linked to survival rates. prostate cancer, for example, has extremely high one year survival rates — around 100% — whether it is detected in stages 1, 2, or 3, falling to 87.6% if detected in stage 4. Research by McKinsey suggests that the health improvement opportunity in Europe lies mainly in the area of disease prevention and earlier intervention.

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 regulatory upheaval in the UK and EU, with the introduction of a new regulatory framework in the UK and In-Vitro Diagnostics Regulation (IVDR), represents both an opportunity to address the issue and a risk for bottlenecks.

Regulatory landscape for IVDs

European Union

The regulatory landscape in Europe is experiencing revolutionary change with the introduction of the EU MDR and EU IVDR. Since May 2022, the In-Vitro Diagnostics Regulation (EU) 2017/746 (IVDR) fully applies and demands, among other things: greater transparency, enhanced harmonization and standardization, more regularity scrutiny, increased obligations and oversight by economic operators and notified bodies, more stringent criteria for clinical evidence, and performance evaluation as well as heightened traceability across supply chain through Unique Device Identification (UDI).

Within the IVDR, IVDs have been divided into four classes based on both their intended purpose and inherent risks. The risk classification system has been established following seven classification rules described in ANNEX VIII of the EU-IVDR. Each manufacturer is responsible for applying the right risk class to its IVD and needs to provide a justification for this decision. Higher risk devices will be subject to more regulatory scrutiny, however, wrong classifications that result in a deviated conformity assessment route are likely to end up causing delays to market entry, stopping patients and healthcare providers from accessing the tools they need for speedy diagnosis.

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 (NB). As of today, there are only 12 appointed NBs for IVDs in Europe, so ensuring that a NB takes on a new device is not an easy feat.

Despite this, frequent pushing back of deadlines and lack of access to EUDAMED have lulled manufacturers into a state of inactivity with many failing to make contact with an NB in good time for an 18-month regulatory approval pathway. The EU has in fact recently proposed an extension to the transitional provisions for certain IVD devices, postponing deadlines once again.  Specifically, the proposal amends Article 110 IVDR and grants additional time to certify legacy devices under the IVDR, moving deadlines to December 31, 2027, for legacy IVDs Class D, December 31, 2028, for legacy IVDs Class C, and December 31, 2029, for legacy IVDs Class B and Class A sterile.

However, manufacturers need to meet certain conditions to be eligible for extension, such as having applied to a NB at least two years before the compliance date (i.e. September 2025, September 2026, and September 2027, respectively, for Class D, Class C, Class B, and A Sterile devices).

To ensure the much-needed instruments to help national health systems make early diagnoses, improving patient outcomes and system efficiency stay on the market, manufacturers should pick up the pace of their compliance activity, especially considering current low NB capacity.

United Kingdom

From a regulatory standpoint, following Brexit, the UK now has the freedom to look at innovative and new ways to increase IVD products on market and reduce the regulatory burden, whilst maintaining high patient safety standards. The development of a new UK-only regulatory system represents a key opportunity to ensure that more IVDs are able to make their way onto the market.

For the time being, while the MHRA is increasing its engagement with industry and industry bodies (BIVDA, ABHI, etc.), extended use of CE marking for IVDs in the UK market has been taken up to June 2030. In addition to this, the UK is working towards dual country approvals and, supporting the UKs intention to be a hotbed for innovative technology, the MHRA announced in September 2023 the introduction of the Innovative Devices Access Pathway (IDAP) to “bring new technologies and solutions to the National Health Service (NHS) to help with medical needs that are not currently being met.”

Confirming that the government wants to make the UK the global home of medical technology and breeding ground for innovation as set out in the Medical Technology Strategy, a recent roadmap by Cambridge Design Partnership, in partnership with CPI, the Association of British HealthTech Industries (ABHI) was developed. The NHS has also recently announced NHS staff will be given the latest artificial intelligence (AI) technology to diagnose and treat patients more quickly thanks to a new £21 million fund.

The healthcare landscape is slowly shifting from the traditional model of treating illnesses reactively, towards a proactive strategy. This new approach builds on the importance of early detection and differentiation of health conditions. In this context, IVDs play a pivotal role. IVDs are recognized as essential for safeguarding both the healthcare system and society as a whole. These diagnostics not only aid in the identification of known pathogens but also serve as a crucial defence mechanism against emerging and evolving new pathogens, contributing to the overall resilience and preparedness of the healthcare infrastructure.

Increasing the use of IVDs in healthcare, however, is not possible unless these are making their way through regulatory pathways steadily and successfully. In this complex international scenario, the role of 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.

About the Author(s)

Jonathan Ripley

IVD and MD Consulting Services Director, IMed Consultancy

Jonathan Ripley is IVD and MD Consulting Services Director at IMed Consultancy.

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