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In the interview, Dr. Stange provides an outlook of the consequences that the implementation of the new regulation IVDR will bring for the market and for individual companies.

New requirements based on the IVDR: An interview with Vice President Dr Andreas Stange

In vitro diagnostics (IVD) are facing the obligation to correspond to Regulation (EU)
No. 2017/746 (IVDR) with effect from 2022. As the new regulation introduces significantly stricter requirements, Dr. Andreas Stange, Vice President IVD global, urgently recommends companies to start addressing the new regulations in detail today.

Important changes concern aspects such as risk classification, vigilance requirements, clinical evaluation of the IVD, tracking and tracing of devices by means of European databases (EUDAMED), and unique device identification (UDI). In addition, the new regulation also covers new product groups such as companion diagnostics (CDx), and thus highly innovative IVDs. These changes mean that 80 percent of IVDs will have to be certified by a notified body in the future, compared to the previous 15 percent.

In the interview, Dr. Stange provides an outlook of the consequences that the implementation of the new regulation will bring for the market and for individual companies.

What is the current greatest obstacle facing the precision medicine and diagnostics community?

We believe that the reimbursement schemes for companion diagnostics (CDx) may not yet be clear enough. From our viewpoint, the changes regarding the implementation of the IVDR are very significant, particularly for smaller enterprises or enterprises completely focused on companion diagnostics that may not yet have worked with a notified body.

Another development is how will Brexit work out? Still, this is not clear. Will it be a hard exit as we hear from some politicians or will it be possible to work out a reasonable agreement between the EU and UK? This uncertainty is not good. All the economic stakeholders need to understand the different possibilities so they can manage the economic risk appropriately.

The increased scrutiny of IVD devices intended for patient stratification may lead to a delay of availability of the diagnostic device.

Describe the role of the notified body under the new IVDR, and the steps TÜV SÜD are taking to ensure quality in diagnostics manufacture?

For medium- and high-risk medical IVDs, notified bodies are involved in the conformity assessment process as a third party to verify compliance of the manufacturer and their products with requirements of the regulation.

TÜV SÜD has been one of the first notified bodies to be designated for all medical device directives, including the European Directive IVDD. We have more than 20 years experience as a notified body.

We also play an active role in discussing the implementation of new regulations, including the IVDR, together with the stakeholders in Brussels, representing the notified body in various expert groups organized by the European Commission.

Besides that, a TÜV SÜD member is also appointed as Vice President of Team-NB, the European Association for Medical Devices of Notified Bodies, since 2013. We are preparing to work as a notified body under the IVDR and are confident of becoming one of the notified bodies designated in the first wave by the Commission under the new IVD regulation. To cope with the increased workload, we are significantly ramping up our expertise and workforce in Europe in anticipation of the IVDR.

A crucial aspect will be the clinical evidence needed, based on clinical data as well as performance studies.

How will the new IVDR impact precision medicine development, drug-CDx launch and diagnostic uptake in Europe?

If not considered in planning and respective measures taken, the increased scrutiny of IVD devices intended for patient stratification may lead to a delay of availability of the diagnostic device.

This may delay the execution of the clinical studies to follow, and thereby the launch of the drug-CDx combination. A crucial aspect will be the clinical evidence needed, based on clinical data as well as performance studies.

One important question is, what data from pharmaceutical studies will be utilized? For some indications, there will only be small patient populations available. How this will be addressed is the question.

Perform a product portfolio review to find the gaps in your quality management system and technical documentation.

What would be your one piece of advice for someone looking to get IVD approval in Europe?

The first thing is to make yourself familiar with the regulatory changes throughout your organization.

Secondly, to perform a product portfolio review to find the gaps in your quality management system and technical documentation.

Another important aspect is to secure resources to cope with the future regulatory burden. You’ve got to be ready in time for the changes. Starting with the date of the application of the IVDR, May 26, 2022, all products must comply with the requirements of the IVDR.

What is the greatest challenge facing the launch, commercialization and adoption of a drug-IVD product?

We are in the relatively early stages of development for such devices. The big challenge is that many of the markers which are currently developed may become obsolete in a couple of years.

The major challenge will be the scientific validity of the biomarker(s) selected for the intended patient stratification.

The big challenge is that many of the markers which are currently developed may become obsolete in a couple of years.

Which technology or innovation in diagnostics is most likely to disrupt the standard of care?

From our viewpoint, we expect continued development in high-throughput sequencing approaches as well as big data processing in the liquid biopsy field, which is currently somewhat a complementary technology.

Dr. Andreas Stange

Dr. Andreas Stange

Vice President Medical Health Services IVD global

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