The implementation of the new In Vitro Diagnostic Regulation (IVDR) within the European Union (EU) has introduced profound changes with far-reaching impacts on both manufacturers and users of in vitro diagnostic devices.
Manufacturers operating within the EU are facing a vastly different regulatory landscape with the advent of the IVDR. This regulation places more stringent demands on manufacturers, necessitating a comprehensive overhaul of their operations. A primary focus is on compliance, with manufacturers required to meet rigorous regulatory requirements. This includes the submission of robust clinical data, exhaustive performance evaluations and the implementation of rigorous quality management systems.
The IVDR also introduces changes in the classification and risk assessment of in vitro diagnostic devices. Manufacturers must meticulously assess the risk profile of their products, which may lead to reclassification and the need to modify device labeling and documentation accordingly. These demands have increased the compliance burden, demanding a significant investment of time and resources.
The IVDR also champions transparency. Manufacturers are required to furnish comprehensive information on device performance, clinical evidence and instructions for use. This enhanced transparency equips users with richer data, enabling more informed decision-making in clinical practice. Moreover, the regulation emphasizes post-market surveillance and reporting, which should lead to improved data quality. This is anticipated to raise the overall quality of diagnostics, ultimately resulting in improved patient care.
However, users should anticipate transitional challenges during the shift from the previous regulatory framework to the IVDR. This transition may lead to temporary disruptions in the availability of certain diagnostics, necessitating careful planning and communication within healthcare institutions.
In conclusion, the IVDR represents a seismic shift for manufacturers and users of in vitro diagnostic devices in the EU. While manufacturers grapple with increased regulatory demands and compliance complexity, users can expect enhanced access to high-quality diagnostics, greater transparency and elevated patient safety. Adapting to these changes is imperative for all stakeholders to ensure continued access to safe and effective diagnostic tools in the EU market. Ultimately, the IVDR’s overarching goal is to enhance healthcare outcomes by elevating the performance and safety standards of in vitro diagnostic devices, benefitting both manufacturers and users in the long term.
Join this webinar to learn how the new In Vitro Diagnostic Regulation (IVDR) impacts manufacturers and users of diagnostic devices.
Dr. Sébastien Barradeau, Global Head of IVD Medical Device, Cerba Xpert
Dr. Sébastien Barradeau joined Cerba Xpert in 2022 as Director of Medical Devices. Cerba Xpert, the IVD Contract Research organization of the Cerba Research company, offers a full service (biospecimen procurement, clinical trials capabilities, testing and performance evaluation for CE marking and FDA approval) to aid IVD manufacturers in the entire process, from development to post-market support. Before that, Dr. Barradeau held scientific and regulatory affairs leadership positions at pharmaceutical companies such as Aventis and Genfit, and at small- and medium-sized biotechnology companies such as Genomic Vision and Diagast. He holds a Doctorate in Molecular Biology and Genetics at the University of Paris 7 and at the Institut Pasteur in Paris.
Marie-Laure Delalande, Head of IVD Operations, Cerba Xpert
Marie-Laure Delalande joined Cerba Xpert in 2023 as Head of IVD Operations. Cerba Xpert, the IVD Contract Research organization of the Cerba Research company, offers a full service (biospecimen procurement, clinical trials capabilities, testing and performance evaluation for CE marking and FDA approval) to aid IVD manufacturers in the entire process, from development to post-market support. Before that, Marie-Laure started her career at the European Center of Nuclear Research (CERN) in Geneva as a system engineer. Several years later, she held research and development engineer positions at STAGO, a pharmaceutical group in the in vitro diagnostics industry dedicated to hemostasis and thrombosis exploration. In the same group, she has been promoted to the Evaluation Laboratory leadership position to take part in the evaluation of the performance of new modules and/or new analysers for CE marking and FDA approval. She holds a Master’s degree in Mechanical at the University of Grenoble.
Who Should Attend?
This webinar will appeal to professionals in the following areas:
- Regulatory Affairs Professionals
- Quality Assurance Managers
- Clinical Operations Professionals
- Clinical Research Professionals
- Medical Affairs Professionals
- R&D Project Managers
- Medical Biologists
- Medical Laboratory Managers
What You Will Learn
In this webinar, viewers will learn:
- How the new In Vitro Diagnostic Regulation (IVDR) impacts manufacturers and users of diagnostic devices
- The specific compliance requirements, risk assessments and quality management changes mandated by the IVDR
- The benefits of enhanced patient safety, transparency and improved diagnostic data for users
Cerba Research, a strategic provider of diagnostic solutions, supports drug development by leveraging patient data and scientific insight to optimize R&D and commercialization globally. Providing early phase research, clinical development through central laboratory and diagnostic testing, assay and biomarker development and validation — through our global network of specialty laboratories. We partner with government agencies, non-government organizations, as well as pharma and biotech organizations to change the shape of clinical development and advance healthcare. Cerba Research is part of Cerba HealthCare, a leading player in medical diagnosis.