What the upcoming In Vitro Diagnostic Device Regulation (IVDR) means for you and how you can prepare for it.
Under the existing IVDD, approximately 80% of IVD manufacturers are self-certified and do not require Notified Body involvement. The new IVDR comes with new classification rules which will in the near future require about 80% of IVD manufacturers to require some form of Notified Body involvement, a four-fold increment from before.
Be ready for these changes, download this whitepaper and find out:
- Why the IVDR is necessary
- What are some of the most significant changes
- The role of notified bodies