MDR Transition: Why the Change, and What are the Changes?

Changes to European regulations have sparked a lot of talk about new requirements.

Around the globe, many wondered what these changes meant, and how they would impact medical device companies. Over the past several years, news about these changes left many companies anticipating and preparing for necessary regulatory updates, and associated documentation remediation. As of May 26, 2021, these changes officially arrived as the new Medical Device Regulation (MDR) was implemented. While MDR serves as a replacement for the previous Medical Device Directive (MDD), many MDD requirements have simply been enhanced and updated with stricter regulations via MDR. A common question we’ve been asked at Rook is, “Why did these changes take place at all?”

In short, the goal of these changes is to improve the transparency of medical devices across the European Union (EU) to consumers, thus increasing the safety and quality of these devices. Additionally, with advancements in technology and the increasing use of software in medical devices (SiMD), several updates were needed.

Another common question that’s emerged is “Are these changes required?” The short answer: If your product is currently being marketed (or if you have plans to market) in one of the EU regions, then yes; these changes are mandatory as applicable.

A few updates worth highlighting include changes to product classification and unique device identification requirements, enhancements and tighter controls to the clinical evaluation process, new requirements for regulatory personnel, a more robust post-market surveillance process, and the implementation of the more publicly accessible medical device database, EUDAMED.

In summary, the new MDR requirements offer a more robust approach to the entire product life cycle. Sound like a lot of highly complex information? No worries: Rook Quality Systems has been helping med device companies overcome regulatory hurdles, navigate regulation changes, and get quality products to market for nearly a decade, and we’re ready, willing and able to be of service.

At Rook, we can help identify gaps in your current quality management system, and tailor a MDR transition plan for your company to market in the EU in a fashion compliant to the new regulations and, most importantly, safe and effective for customers. Contact us today for more information.