Navigating IVDR: Challenges and Strategies for Clinical Trial Assay Development and Regulatory Submissions

Life Sciences, Clinical Trials, Medical Device, Medical Device Clinical Trials, Medical Device Safety and Regulation,
  • Monday, June 26, 2023

Over the past year, in vitro diagnostic regulation (IVDR) has emerged as a pivotal regulatory framework for ensuring the safety, performance and reliability of medical devices, but navigating the IVDR landscape has been met with challenges. With the implementation of IVDR, it is crucial for clinical trial sponsors and CROs to understand the complexities and nuances of this regulation to successfully navigate the path from assay development to regulatory submission and approval.

This webinar aims to provide a comprehensive overview of IVDR and explore the challenges encountered during the submission and approval process for clinical trial assays, including examples of feedback received from Member States and how to address them. It will discuss the delegation of responsibilities to CROs by clinical trial sponsors, as well as emphasize the criticality of performance study documentation to help the clinical trial assay along the path to regulatory submission and approval. Additionally, participants will gain insights into the classification of medical devices based on the rules outlined in Annex VIII of the IVDR.


The webinar will commence with an introduction to IVDR, outlining the key principles and objectives. Participants will gain a better understanding of the regulatory landscape and the impact of IVDR on clinical trial assay submissions. A discussion of how to navigate the delegation of responsibilities from clinical trial sponsors to CROs will be discussed. Participants will learn about the necessary contractual agreements, communication channels and quality management systems that facilitate successful collaborations.

The webinar will delve into the specific challenges faced during the IVDR submission process for clinical trial assays, even if there is no intent to commercialize the assay. Participants will be guided through the intricacies of compiling and submitting the required documentation, including clinical and analytical performance reports and scientific validation data. Special attention will be given to addressing common pitfalls and identifying potential roadblocks, with practical tips for overcoming them. A discussion of feedback that CellCarta has received from Member States and how they were addressed will be reviewed.

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Finally, the webinar will provide a brief explanation of the classification of medical devices based on the rules outlined in Annex VIII of the IVDR to provide a better understanding of the classification criteria and the impact on the regulatory pathway the device must follow.

Register for this webinar to gain a comprehensive overview of IVDR and its implications for clinical trial assay submissions. Learn how to navigate challenges, address feedback, and ensure compliance with the regulation.


Pamela Swatkowski, CellCarta

Pamela Swatkowski, Vice President of Global Regulatory Affairs, CellCarta

Pamela Swatkowski has extensive leadership experience in regulatory affairs, quality assurance, business development, clinical and research and development in the medical device and IVD industry in the US food and Drug Administration (FDA)-regulated diagnostic industry leading US and international regulatory submissions and global compliance activities.

Her medical device experience includes: molecular infectious disease, oncology, companion diagnostics, single site IVD global approvals, NGS based immuo-sequencing, microbiology, genetics and immunology in vitro diagnostic assays and instruments, injection molded devices, peritoneal dialysis catheters and orthopedic spinal implants. She was also the President and Founder of PLS Consulting, LLC. Pamela previously held leadership positions in quality, regulatory affairs and compliance positions at Abbott Molecular and Thermofisher. She has a degree in biology and chemistry from Loyola University of Chicago.

Pamela is a member of multiple diagnostics, global and next-generation sequencing (NGS) working teams consisting of device and pharmaceutical industry, regulatory agencies and patients. She has spoken at various international meetings on device regulation, personalized medicine and IVD regulatory strategy and represented the IVD industry position to the FDA as part of the US Congressional 21st Century Cures Act Precision Medicine Cancer Moonshot initiative to accelerate cancer research through optimization of regulatory policies to promote research, accommodate innovation in test development and accelerate the translation of precision medicine technologies into treatments that benefit patients.

Message Presenter
Rachel O’Leary, CellCarta

Rachel O’Leary, Regulatory Affairs Project Manager, CellCarta

Rachel O’Leary is a professional in regulatory affairs, business development and project management in the drug stability and most recently, IVD industry. She previously held leadership roles in project management at PPD. Rachel holds a Bachelor of Science degree in Biochemistry from the University of Wisconsin.

Message Presenter

Who Should Attend?

  • Individuals who are interested in the impact of IVDR on clinical trials with a biomarker inclusion criteria
  • Regulatory professionals, clinical project managers and others who can benefit from a CAP/CLIA laboratory perspective

What You Will Learn

This webinar will benefit participants involved in the development and submission of clinical trial assays. They will:

  • Gain valuable insights into the IVDR submission process
  • Be equipped with the knowledge and strategies required to overcome challenges, ensure compliance and streamline the path from assay development to successful submission
  • Learn how to properly navigate the IVDR landscape and ensure that clinical trial assays have the best chance of approval

Xtalks Partner


CellCarta is the leading provider of specialized precision medicine laboratory services to the biopharmaceutical industry. Leveraging its integrated analytical platforms in immunology, histopathology, proteomics and genomics, as well as related specimen collection and logistics services, CellCarta supports the entire drug development cycle, from discovery to late-stage clinical trials.

The company operates globally with 10 facilities located in Canada, USA, Belgium, Australia, and China.

For more information on how CellCarta can partner with you, please contact us:

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