EU proposes extension to transitional provisions for certain IVD devices

The EU has 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 In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746 (‘IVDR’), provided manufacturers meet certain conditions, such as having applied to a Notified Body at least two years before the compliance date (i.e. September 2025, September 2026 and September 2027 respectively for Class D, Class C, and Class B and A Sterile devices).

Transitional provisions should not slow efforts
The transitional provisions would shift deadlines as follows:
The introduction of the EU MDR and EU IVDR is drastically changing the European regulatory landscape in Europe. As of 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 of economic operators and notified bodies
• more stringent criteria for clinical evidence and performance evaluation
• heightened traceability across supply chain through Unique Device Identification (UDI)

Within the EU IVDR, IVDs have been divided into four classes based on both their intended purpose and their inherent risks: Class A (low individual risk and low public health risk), Class A sterile subclass, Class B (moderate individual risk and/or low public health risk), Class C (high individual risk and/or moderate public health risk), and Class D (high individual risk and high public health risk).

Manufacturers are responsible for applying the right risk class to their IVD, and for providing a justification for this decision. Any 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 in fact 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 of today, there are in fact only 12 appointed Notified Bodies for IVDs in Europe, so ensuring that a NB takes on a new device is not something to be taken for granted.

The latest proposed push back of deadlines risks to lull manufacturers into a state of inactivity with many failing to make contact with a NB in good time for an 18 months regulatory approval pathway. As a result, the much-needed instruments to help national health systems make early diagnoses, which are key to improving patient outcomes and system efficiency, may not be available when they are needed.

Leveraging UK focus on innovation to drive early diagnosis
When it comes to regulations, the UK has the freedom to look at innovative and new ways to increase volumes and range of IVD products on market and reduce the regulatory burden, whilst maintaining high patient safety standards. The development of a new UK-only regulatory system therefore 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.), extend 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 UK’s intention to be a hotbed for innovative technology and IVDs, 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.”

The UK Government is in fact planning to position the UK as the global home of medical technology and breeding ground for innovation as set out in the Medical Technology Strategy but also with a recent roadmap by Cambridge Design Partnership, in partnership with CPI, the Association of British HealthTech Industries (ABHI).

Additionally, the NHS has recently announced that, thanks to a new £21 million fund, NHS staff will be given the latest artificial intelligence (AI) technology to diagnose and treat patients more quickly, recognising the importance of early diagnosis to spot diseases before they become more complex and expensive to treat.

Early diagnosis plays a critical role in patient outcomes, ensuring patients understand how their symptoms will evolve over time and how this can be changed with treatment. Early diagnosis also allows targeted interventions to start earlier, before potentially irreversible damage has occurred, helping to slow or reverse the disease process, especially in often asymptomatic conditions such as type 2 diabetes, hypertension, and hyperlipidaemia and oncology. 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.

Early intervention results in better outcomes, but also 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 the EU IVDR in Europe are both an opportunity to address the issue and a risk for further bottlenecks in this device area.

As healthcare moves towards a more proactive form of prescribing that aims to “detect and contrast” early on, IVDs are becoming pivotal tools to protect the healthcare system and society from a range of known and new pathogens. However, to increase use of IVDs in healthcare is necessary to make sure these are making their way through regulatory pathways steadily and successfully.

In this complex scenario, the role of regulatory consultancies takes on critical importance in informing, advising and supporting IVD manufacturers so that their 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, that can be treated with drugs or minor procedures that are not particularly expensive and are minimally invasive for patients. Medical Product Outsourcing