Interview with Dr. Stefan Burde, Global Director IVD Focus Team at TUV SUD
6 min

Interview with Dr. Stefan Burde, Global Director IVD Focus Team at TUV SUD

Learn insights on the significance of the IVDR and its impact on the in vitro diagnostics (IVD) industry.

Date: 30 Aug 2023

Today, we have the privilege of speaking with Dr. Stefan Burde, the Global Director of the IVD Focus Team at TÜV SÜD. Stefan has a wealth of experience in the field of in vitro diagnostics and has recently taken on a new role. Let's delve into the discussion and learn more about his experiences and insights.

Welcome, Stefan!


Stefan Burde: Thank you for having me. I'm delighted to be here and share my perspectives with you.

Interviewer: It's a pleasure to have you. Let's start by discussing your position as the Global Director of the IVD Focus Team at TÜV SÜD. Can you provide some details about your role and the responsibilities it entails?

Stefan Burde: Sure. As the Director of the IVD Global Focus Team at TÜV SÜD, my primary responsibility is to guide the global teams that focus on in vitro diagnostics (IVD). I am involved in coordinating the efforts to ensure compliance with relevant regulations and standards in the IVD industry, including the new In Vitro Diagnostic Regulation (IVDR). I also work with our clients to ensure appropriate regulatory compliance and timely conformity assessment of their IVD devices. It's a challenging but fulfilling position that requires a deep understanding of the IVD industry and regulatory requirements.

Interviewer: That sounds like a crucial role in ensuring the quality and safety of IVD products. You mentioned the IVDR. Could you shed some light on its significance and the impact it has on the IVD industry?

Stefan Burde: Absolutely. The IVDR, or In Vitro Diagnostic Regulation, is a new regulatory framework that governs the market access and safety of in vitro diagnostic medical devices within the European Union. It replaces the previous In Vitro Diagnostic Directive (IVDD) and introduces more stringent requirements for manufacturers. The IVDR places a greater emphasis on clinical evidence, performance evaluation, and post-market surveillance. Its primary objective is to enhance patient safety and improve the reliability and quality of IVD devices.

The IVDR brings about significant changes in the IVD industry. It broadens the scope of devices covered, including previously unregulated products such as companion diagnostics and certain genetic tests.

Manufacturers now need to classify their devices based on the risk they pose to patients, and higher-risk devices require involvement from notified bodies like TÜV SÜD for conformity assessment. While only about 10% of devices were subject to conformity assessment by a notified body under the IVDD, at least 80% of devices will require notified body review under the IVDR. The IVDR also mandates a comprehensive performance evaluation process for devices, emphasizing clinical evidence, analytical performance, and scientific validity.

The impact of the IVDR is substantial. Manufacturers must update their technical documentation, conduct clinical studies, and demonstrate compliance with the new requirements. Notified bodies like TÜV SÜD have to expand their capabilities to meet the increased demand for conformity assessment and certification. The IVDR aims to ensure that IVD devices on the market meet the highest standards of safety and performance, ultimately benefiting patients and healthcare professionals.

Interviewer: Thank you for providing that insight. It's clear that the IVDR brings significant changes to the IVD landscape. How is TÜV SÜD supporting manufacturers in navigating the IVDR requirements?

Stefan Burde: TÜV SÜD plays a crucial role in supporting manufacturers in their journey to compliance with the IVDR. We provide comprehensive conformity assessment services, including, technical documentation review and quality system auditing. We are a full-scope notified body with designation for all categories of devices and technologies, and we support all routes to conformity assessment.

TÜV SÜD is dedicated to supporting manufacturers in introducing cutting-edge devices to the market, ensuring that people in Europe and other regions relying on the CE-mark have access to state-of-the-art diagnostic technologies. While the European Commission's ongoing efforts, such as extending transition timelines through Regulation (EU) 2022/112 and implementing leveraged reviews outlined in MDCG 2022-14, primarily focus on preserving market access for existing devices, the field of in vitro diagnostics is experiencing rapid evolution.

Recognizing this dynamic landscape, TÜV SÜD remains committed to staying up-to-date with the latest advancements in IVD technologies. We continually monitor emerging developments and enhance our expertise to provide comprehensive conformity assessment services for novel devices. By doing so, we actively contribute to facilitating the introduction of innovative IVD solutions, enabling healthcare professionals and individuals to benefit from the most advanced diagnostic tools available.

Interviewer: That's fantastic to hear. The support and expertise provided by TÜV SÜD are crucial for manufacturers in adapting to the new regulatory landscape. Looking ahead, how do you see the future of the IVD industry, considering the evolving regulatory environment and technological advancements?

Stefan Burde: The future of the IVD industry holds great promise. The rapid advancements in technology, such as molecular diagnostics, point-of-care testing, companion diagnostics, and digital health solutions, are transforming the way healthcare is delivered. These innovations enable faster and more accurate diagnoses, personalized treatments, and improved patient outcomes.

However, with these advancements come increased regulatory challenges. As technology continues to advance, regulators must adapt to ensure the safety and effectiveness of new IVD products. Harmonizing global regulations and streamlining regulatory processes will be critical to foster innovation while maintaining rigorous quality standards.

Moreover, as the industry progresses, we can expect further integration of digital health technologies, data analytics, and artificial intelligence in IVD. These advancements will enhance diagnostic accuracy, enable remote monitoring, and facilitate more efficient healthcare delivery.

Overall, the future of the IVD industry is exciting, with opportunities for innovation and improved patient care. Adapting to regulatory changes, embracing technological advancements, and ensuring robust quality systems will be essential for manufacturers to thrive in this evolving landscape.

Interviewer: Thank you, Stefan, for sharing your valuable insights on the IVDR and the future of the IVD industry. It has been a pleasure speaking with you and learning from your experiences.

Stefan Burde: Thank you for having me. I appreciate the opportunity to discuss these important topics. I look forward to seeing how the IVD industry continues to advance and contribute to healthcare worldwide.

Dr. Stefan Burde is a highly accomplished professional in the field of in vitro diagnostics (IVD). Serving as the Global Director of the IVD Focus Team at TÜV SÜD, Stefan brings extensive expertise in IVD regulations, quality systems, and strategic guidance. With a background in pathology and experience in prestigious organizations, Stefan is known for his contributions to the development of molecular diagnostics and his commitment to patient safety. His leadership and industry knowledge continue to drive innovation and ensure the quality of diagnostic products in the ever-evolving IVD landscape.

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