With so much angst and attention directed at the new EU Medical Device Regulation, the parallel IVD Regulation is getting overshadowed, even though it represents an even bigger change from the status quo. Emergo by UL’s Oliver Eikenberg offers 10 key checks that companies should perform to help ensure they are prepared for the IVDR.
Under the current EU IVD Directive, upwards of 90% of diagnostics can enter the market based on a company’s self-certification, without notified body review. Under the IVD Regulation, which is set to take full effect in 2022, the situation will flip on its head, with more than 80% of diagnostics requiring an assessment from a notified body. That represents a paradigm shift to the market that is more significant than the impact felt from the much-dreaded EU Medical Device Regulation. And with less than two years to go until IVDR liftoff, companies have a lot to do to keep their tests compliant going forward.