Developed and drafted at the same time as the Medical Device Regulation (MDR), the In Vitro Diagnostic Regulation (IVDR) is a significant legislative framework that governs the safety and performance of in vitro diagnostic medical devices (IVDs) in the EU. IVDs are used to perform tests and experiments on biological samples (like blood, tissue, or cells) outside a living body, typically in a lab. 

IVDs help in diagnosing diseases, monitoring health conditions, or studying biological processes. For example, a blood glucose test kit that measures sugar levels in a blood sample taken from the body is an IVD. In recent times, most of the world’s population has had first-hand experience with IVDs in the form of COVID-19 test kits. For manufacturers of these IVDs, understanding and complying with the IVDR is essential.

Since coming into effect in 2021, there have been a number of major amendments to the EU’s Medical Device Regulation (MDR). Adapting to these amendments puts additional pressure on medical device manufacturers, increasing the burden of compliance, putting a strain on internal resources, and causing something of a regulatory headache. 

But it doesn’t have to be that way. In this article, we explore how to handle MDR amendments – both today and tomorrow – by bringing in the right external experts. At the same time, we’ll look ahead at anticipated future changes that could impact your medical device company.

Even a cursory glance at the EU’s Medical Device Regulation (MDR) – over 170 pages, more than 100 articles, plus 17 annexes – tells you one thing: there are no quick-fixes when it comes to regulatory compliance for medical devices. 

To avoid the hassle, delays, and ongoing back and forth with a Notified Body, many medical device manufacturers seek external expertise on regulatory compliance. That’s because getting the Quality Systems Requirements (QSR) and the product documentation right first time enables them to bring their medical device to market, faster and more easily.

This is why many medical device companies turn to consultants who possess both regulatory expertise and the ability to take a personalized approach to compliance. In other words, they seek consulting excellence that fits their organization and product.