IVDR Survival Guide: Know the 4 Main Challenges and How to Overcome Them

  • Free

Why attend?

With the positive aim of increasing patient safety, the In Vitro Diagnostic Regulation (IVDR) has fundamentally changed the way in vitro diagnostics (IVD) are regulated in the EU. The depth of expectations for review and documentation have increased substantially. As a result, IVD sponsors are having to adapt to a daunting set of regulatory updates.

This webinar will walk through the four primary challenges to IVDR conversion and provide solutions to simplify and de-stress the process so that IVD manufacturers can approach deadlines with more confidence and avoid having products pulled from the market.

Topics addressed:

  • New IVDR product classification system

Under the new IVDR, a four-class system replaces the old in vitro diagnostic medical devices directive (IVDD) two-class system. Significantly more products fall into the higher risk groups. What are the most notable new rules and modifications to existing rules? How open are they to interpretation? How do you determine what you need to do differently for compliance now?

  • Dramatic increase in Notified Body (NB) oversight

It’s estimated that, under the new system, the proportion of products requiring NB oversight will increase from 20 percent to 80-90 percent. How will this affect the level of scrutiny on products old and new, the conformity assessment criteria and the level of documentation required?

  • Combined pressures creating a NB bottleneck

Just as demand is up, the number of NBs has diminished. Excessive demand, the Consolidated NB initiative, increased training requirements and COVID-19 have created a perfect storm making NB evaluations a rare commodity. What do you do when you need one, but the wait time exceeds your product registration date?

  • Clinical evidence and performance requirements

Whereas in the past, clinical evidence was not needed, IVD manufacturers now need to show a legitimate level of product performance. But what is acceptable evidence and what isn’t for the different classes of devices? What paperwork is needed? When and how must you perform a complete clinical study?

Key Learning Objectives

  • Understand the new IVDR product classification system
  • Learn how to manage the dramatic increase in NB oversight
  • Learn how to navigate the combined pressures creating a NB bottleneck
  • Identify the clinical evidence and performance requirements

Target Audience

  • Heads of Research and Development
  • C-suite
  • VP
  • Director
  • Small to mid-size Pharma
  • Diagnostics, Drug & Medical Devices

Speakers

Select a speaker to learn more

Caroline Perez
Associate Director, Regulatory Affairs, Premier Research

Caroline Perez has more than 20 years of international clinical research experience in medical devices and pharmaceutical products. As Associate Director of Regulatory Affairs, she oversees critical elements of regulatory strategy and business acquisition, advising customers and members of the company’s clinical team on regulatory and technical subjects.

Prior to joining Premier Research in 2009 as a Senior Project Manager, Dr. Perez was a Project Manager and Clinical Research Associate at MedPass International, a Paris-based contract research organization specializing in medical devices. She also worked as a Clinical Research Associate at Ciba VISION, a producer of contact lenses, and at Bristol Myers Squibb. Her broad therapeutic experience spans medical devices, ophthalmology, oncology, and neurology.

Dr. Perez holds a doctorate in organic chemistry from the Institute for the Chemistry of Natural Substances in Gif-sur-Yvette, France, and did a post-doctorate in organic chemistry at the Martin Luther University of Halle-Wittenberg in Germany.

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Matt Nowland
Vice President, Regulatory Affairs & Quality, Premier Research

Relying on more than 20 years of success, Mr. Nowland helps sponsors to optimize regulatory strategy as they seek to bring new diagnostics to market. He has helped companies from venture capital backed start-ups to large global entities, to develop and advance innovative technologies, including molecular diagnostics, medical devices, surgical robotics, and blood products.

Mr. Nowland has firsthand experience working within biotech, device, and diagnostics companies to develop and oversee pre- and post-approval activities in areas including, but not limited to, oncology, neurology, cardiology, inflammation, and infectious disease. Under Mr. Nowland’s leadership, Premier supports diagnostics developers with strategic planning, regulatory strategy, process improvement, risk mitigation and quality assurance, clinical monitoring, and regulatory submissions.

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