And just like that, a year has passed and we witnessed the IVDR roll-out. At the outset, IVDR may appear to be a simple guidance for IVD products, however, there are subtle nuances that help decide the regulatory strategy for these devices.

Important takeaways from the MDR roll-out will help inform implementation of regulatory strategies for IVDR! Both the IVDR and MDR aim to address patient safety and transparency, with increased requirements for clinical evidence and scrutiny of data.

However, unlike the gradual changes made to MDD before being repealed by MDR, the IVDD was never updated and the depth of expectations under IVDR may impede certification.

What do you do when your IVD product relies on software to test samples, the results of which are used to plan the treatment? Will the software be considered a separate medical device? What aspects of the software will need to be tested? What regulations and standards come into play?

Where originally only 10-20% IVD devices were undergoing a notified body review, we are now expecting to see a whopping 80-90% of IVD devices needing this oversight for market clearance. Given the increased need and the relatively low number of notified bodies for IVDR at present, the last thing you’d want as a manufacturer is to have multiple reviews and back and forth due to an incomplete understanding of the regulations.

We, at Bannick, have extensive expertise in the implementation of regulatory strategies for IVD products. Need a dynamic team to help navigate this maze of regulations? Let’s chat!

IVDR Puzzel Pieces