So why do we keep talking about it, including in our most recent article on the seventh Notified Body designated under the new EU In Vitro Diagnostic Medical Devices Regulation? It’s not for the good of our health, but it might be for the good of some seriously unwell patients.

Medical devices have always been a vital part of healthcare. Surgical pins help to repair shattered bones after car accidents. Hip implants keep elderly people mobile as their bodies age. X-ray machines, MRIs and CT scanners allow doctors to non-invasively investigate physical conditions and internal injuries which would be invisible to an external examination. Lateral flow diagnostic tests helped us to keep our family, friends, and colleagues safe from COVID-19 as we returned to socialising again after the first lockdowns. There are countless other examples. Yet, despite the obvious importance of medical devices, they have historically received much less attention from policymakers and the press than pharmaceuticals. However, that has begun to change in recent years.

The change is partly due to patient safety scandals, such as those surrounding PIP implants and metal-on-metal hips, which exposed a need for more regulatory scrutiny of medical technology. The change is also partly because medical devices are becoming much more exciting, sophisticated and influential. This is especially true of in vitro diagnostic medical devices (IVDs), which are the focus of this series of articles.

The artificial intelligence revolution is driving a boom in software-based IVDs, especially in the field of stratified medicine where algorithms are used to evaluate an individual patient’s genome and estimate the likelihood of them developing a particular condition at some stage in life. At the same time, certain types of IVD known as “companion diagnostics” have enabled the rise of personalised medicine.

Companion diagnostics are used to determine whether a given patient’s condition is likely to be susceptible to treatment with an accompanying medicine, so that the patient can receive treatment tailored to their particular condition. Personalised medicine of this sort is particularly prevalent in cancer treatment, where companion diagnostics are used to determine whether a particular patient’s tumour will be susceptible or not to treatment with different types of chemotherapy. Such IVDs not only help health services to target the patients who will benefit most from expensive cancer treatments, they also help to improve the quality of life of patients who would not benefit from chemotherapy by sparing them a futile and often deeply unpleasant course of treatment.

We keep writing about Notified Bodies on this blog (and will continue to do so) because they are the gatekeepers who decide whether IVDs such as these can be placed on the market in the European Union. Notified Bodies conduct Conformity Assessments under the regulatory framework, which involve assessing the clinical data and technical documentation prepared by manufacturers of IVDs to determine whether the IVD meets the safety and performance requirements set out in the regulatory framework.[1] If an IVD does not pass its Conformity Assessment, it cannot have a CE Mark affixed and it cannot be placed on the market in the European Union.

Under the previous regulatory framework, the overwhelming majority of IVDs were considered “low risk”, and so were exempt from undergoing Conformity Assessment by a Notified Body. That is all changing. Under the IVDR, which will be in full effect from its Date of Application on 26 May 2022, the majority of existing IVDs are “up-classified”, and will now require a Conformity Assessment conducted by a Notified Body.

A survey conducted by MedTech Europe in 2021 estimated that the number of IVDs requiring Notified Body Conformity Assessment will increase by more than 700% under the IVDR.[2] That number not only represents new IVDs which will be developed in the future, it represents existing IVDs which will require a Conformity Assessment just to remain on the market.

Despite the huge uplift in the amount of work for them, the level of Notified Body capacity under the IVDR is still well below where it was under the previous regulatory framework. Where there were previously 18 Notified Bodies[3] to conduct conformity assessments on IVDs under the old framework, now there are only 7 under the IVDR, and the rate of increase is glacial.

This represents a serious barrier to allowing new, innovative IVDs onto the market, but more worryingly, it also represents an obstacle for existing IVDs just to remain on the market. Existing IVDs will not need to undergo a new Conformity Assessment immediately on the Date of Application, as the IVDR contains transitional provisions to allow IVDs certified under the old regulatory framework to remain on the market, but these are time-limited, and IVDs can lose the benefit of them if they undergo a “significant change in their design or intended purpose.” This is why the 2021 MedTech Europe survey estimated that 22% of existing IVDs would unavoidably come off the market as a result of the IVDR, and that in the worst case scenario, 76% of IVDs could be lost. Even the best case scenario presented there could be catastrophic for patient care.

As we have previously written, the European Commission recognises that Notified Body capacity is a problem, and it took steps late last year to extend the IVDR transitional periods in an attempt to ease the burden on Notified Bodies and IVD manufacturers. It also has an implementation plan in place, which is being regularly updated with proposals to manage the transition to the IVDR.[4] Those steps have not been enough to set minds at ease though.

The German and French trade bodies for medical technology recently issued a joint press release calling for urgent action to prevent a “collapse” in patient care arising from medical devices being forced off the market because their manufacturers could not obtain a Conformity Assessment in time. The European Federation of Pharmaceutical Industries & Associations (EFPIA) also issued a press release with the European Cancer Patient Coalition and Diaceutics calling on the European Commission to consider postponing the IVDR Date of Application by at least a year, because of concerns about access to IVDs for use in cancer treatment.

There was never any doubt that the IVDR would have a huge impact on the IVD industry. However, a lack of Notified Body capacity has turned what was supposed to be a positive, transformative impact into a gut punch which will be felt beyond the IVD industry by the pharma industry, healthcare systems and potentially patients themselves.

With only two weeks to go to the IVDR Date of Application on 26 May 2022, some pretty extraordinary measures from stakeholders such as the national Competent Authorities and the European Commission will now be needed to moderate its worst effects. Our future articles will look at what sorts of measures might be under consideration for the first weeks and months of the IVDR.

Read the next article in this Spotlight on IVDR series: “Circumventing the Notified Body bottleneck”

—————–
[1] Notified Bodies also assess other aspects of the manufacturer’s compliance with the regulatory framework, such as the adequacy of its Quality Management System.
[2] https://www.medtecheurope.org/wp-content/uploads/2021/09/medtech-europe-survey-report-analysing-the-availability-of-in-vitro-diagnostic-medical-devices-ivds-in-may-2022-when-the-new-eu-ivd-regulation-applies-8-september-2021.pdf
[3] There has previously been many more than 18 Notified Bodies to conduct IVD Conformity Assessments. However, the number has fluctuated over time, and there was a major reduction in capacity following Brexit as the UK’s Notified Bodies became ineligible to do Conformity Assessments under the EU framework. 18 is the most recent figure.
[4] https://ec.europa.eu/health/system/files/2022-04/md_joint-impl-plan_en.pdf