With the positive aim of increasing patient safety, 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 companies 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.
• New, IVDR product classification system
Under IVDR, a four-class system replaces the old 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% to 80-90%. 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?
Nach Dave, R.Ph., M.S.,
Vice President, Development Strategy, Premier Research
Nach Davé provides strategic and commercial input for Premier Research’s business activities. He brings more than 20 years of experience in the pharmaceutical and contract research industries to the position. He previously served as the Vice President of Regulatory at Premier and has been in leadership positions at both CROs and sponsor companies.
In his current role, Mr. Davé brings innovative solutions and grow Premier’s footprint in the areas of medical device development, real-world evidence, and government relations. He is keen to explore how innovative technology like AI, ML, and other developments can best support the growth of Premier’s business.
Mr. Davé holds a master’s degree in drug regulatory affairs from Long Island University and a bachelor’s degree in pharmacy from the University of Sciences-Philadelphia. He is a registered pharmacist.
Associate Director, Regulatory Affairs, Premier Research