With only 18 months left until the end of its transition period prior to full implementation, the In vitro Diagnostics Regulation (IVDR) is expected to revolutionise the current policy framework. Yet, it still seems to pose challenges for patients, users and manufacturers.

Against this backdrop, Incisive Health, in collaboration with Oliver Bisazza (MedTech Europe), Dr Adela Maghear (European Cancer Patient Coalition) and Prof Elizabeth Macintyre (BioMed Alliance), gathered a wide variety of more than 40 stakeholders on 26 November to discuss the challenges and impact of the IVDR. This event was the second in a series of regular breakfast meetings – the Incisive Health Morning Club – where experts deep-dive into key health policy developments.

The IVDR is not a full-blown revolution of our framework, but it is close to it – Oliver Bisazza

The COVID-19 outbreak has caused a global public health crisis, presenting an extraordinary challenge for national authorities, health institutions, economic operators and most importantly, patients. Among other things, the crisis has highlighted the importance of diagnosis. As in vitro diagnostics represent a large range of devices, from exciting innovative technologies to everyday tests (such as pregnancy tests, nasalpharyngeal swab tests for COVID-19 or cancer tests), we heavily rely on them to ensure the efficiency of modern healthcare.

In that regard, the IVDR aims to modernise the current policy framework for in vitro diagnostics across the EU, putting great emphasis on their safety and reliability. It will bring various improvements in terms of oversight of these tests (pre-market and post-market), the level of clinical evidence, as well as their safety and performance, while bringing more transparency for patients and for the public in general.

For healthcare professionals, the IVDR is also a welcome revolution as it should improve clinical relevance, and discontinue obsolete tests, as highlighted by Prof Macintyre.

In the diagnostics world, the objective is to make the correct and precise diagnosis, initiate the most appropriate treatment, with the minimum number of side effects, and at an optimal cost for patients and society – Prof Elizabeth Macintyre

While there is a need for the in vitro diagnostics framework to be updated, the IVDR also seems to be presenting some challenges, especially when it comes to its implementation. With a generous transition period of 5 years after its adoption in place for a reason, it contains extensive new changes and requires the development of a brand new regulatory infrastructure in order for the regulation to be efficient and deliver its promises. This includes, for instance, a new European database to ensure transparency, testing laboratories to be put in place and conformity assessment bodies (notified bodies) to monitor industry compliance to these new rules, etc. And all of this will need to be in place well in advance of the end of the transition period, in May 2022.

At this stage, however, there is still much to be done, as pointed out by Oliver Bisazza, especially considering the disruption caused by the COVID-19 outbreak on many levels, which has shifted the focus of authorities to other matters. There is a lack of guidance from authorities on how to follow the new rules in order to certify tests. Another serious cause for concern is the insufficient number of notified bodies currently in place to handle the certifications of future tests.

Prof Macintyre also raised other questions that remain to be addressed before the IVDR comes into effect, including the danger of increasing costs of diagnostics for patients and insurers that may have a downside for the improvements planned by the regulation. In the case of in-house testing using laboratory developed tests, it seems that article 5 of the regulation may prevent the use of in-house tests if the patient’s needs can be met by a marketed device, a situation that could lead to the creation of monopolies for rare or novel targets, including in precision/personalised medicine. 

The new regulatory system and the commitments to strengthen transparency and public access to clinical information won’t work without a fully functioning database – Dr Adela Maghear

For Dr Adela Maghear, the key challenge that needs to be addressed from the patients’ perspective is making sure that transparency and safety are guaranteed once the IVDR comes into effect.

While the regulation includes enhanced safety requirements, transparency and strengthened post market surveillance, there is a need to ensure patients’ access to technology and information with a transparent regulatory framework. According to Dr Adela Maghear, this can only happen with a fully functioning EU database, namely EUDAMED, which will also need to be operational by the time the transition period of the IVDR ends.

In vitro diagnostics, especially companion diagnostics, play an essential role in Personalised Oncology. The new In vitro Diagnostics Regulation presents an opportunity for strengthening the current approval system for In vitro diagnostics for the sake of patient safety, competitiveness and innovation.

Over the next 18 months, it will be necessary for regulators, healthcare professionals and the industry to continue preparing for the implementation phase and to clarify the points that still remain uncertain at the moment.

Incisive Health will continue to monitor these developments and support clients and stakeholders in navigating this space. Please contact us if you wish to continue the conversation on the In vitro Diagnostics Regulation.