So much about IVDR is unprecedented. It relegates re-classification to a small minority, and it completely overhauls the expectations associated with your pre-market and post-market data.
This means that capturing the right data and preparing the right documentation for IVD development is going to be more important — and more difficult — than ever. As such, staying on time and on budget will require expert insight with the answers to the most important questions surrounding the IVDR transition:
- Where does my IVD device belong under new risk classifications?
- What all is contained within a high-quality performance evaluation plan (PEP)?
- How has post-market surveillance (PMS) evolved and what is now required?
Successful development will be possible only for those MedTech organizations who can incorporate these new considerations into existing pre-market and post-market procedures for their in vitro medical devices. Read our white paper on “understanding IVDR” to start your organization on a successful regulatory transition.