IVDR Is Coming!

There’s been a lot of talk about the Medical Device Regulation (MDR) and the widespread impact its passage will have on medical device manufacturers, the labs that certify them, and the regulatory bodies that provide oversight. But as Erik Vollebregt points out in this article, there is another regulation we should be focusing on: the In Vitro Diagnostic Regulation (IVDR). In fact, IVDR’s ramifications are even further-reaching, affecting test labs and health institutions, as well, who will have to regularly justify their use of products developed in-house over CE-marked products available on the market to competent authorities.

When it comes to IVDR, preparation is key. Far more products fall under IVDR than under its predecessor, the In Vitro Device Directive. Not only have additional product classifications been added to IVDR’s scope, in vitro device accessories must now be certified, as well. And like most CE-related legislation, existing products cannot be grandfathered. As of the IVDR’s application date, May 26th, 2022, all in vitro devices and their accessories brought to market must be certified. On top of all that, even manufacturers who are ready to submit today cannot because there aren’t enough notified bodies accredited to certify their products, yet. Those products have already started backing up, and with so many products requiring certification, this does not bode well that products will be certified in time for those who have not started preparing for IVDR certification (or worse, who are just now hearing that they need to be certified)!

But make no mistake: the IVDR application date is coming. When the application date comes, the most defensive position by far will ideally be having your products certified. But barring notified body availability, the next-best position is to have your products ready to certify. While we at Realtime can’t do much to get regulators to implement IVDR and get notified bodies certified, we can help you get prepared, helping you gather the evidence you need to support your claims, compiling your technical file, and helping you get set up in EUDAMED as soon as it’s ready. Call us at 972 985-9100 and let Realtime use its expertise in quality management systems, regulatory standards compliance, and systems, software, mechanical, and electrical engineering to help you get prepared.