Compliance & Regulation

EU MDR: What You Need to Know

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EU MDR

The medical device market in Europe is growing fast and is expected to reach $61.4 billion by 2025, up from $48.9 billion in 2020. A large aging population, demand for more surgical procedures, and technological expansion are driving this trend.

The Medical Device Directive (MDD) is a legal framework that includes three directives that are designed to regulate the safety of medical devices in Europe. The MDD came into effect during the 1990s; however, since that time, the technology landscape has quickly evolved. Many technologies that didn’t exist previously, such as software as a medical device (SaMD), are now widely used to treat, diagnose, mitigate, and even prevent disease.

Governing agencies were concerned that the MDD was outdated and didn’t address many evolving safety threats. As a result, they developed a whole new set of standards called the European Medical Device Regulation (MDR). Medical device companies that are already compliant with MDD regulations shouldn’t be fooled into a false sense of security. The EU MDR is far more comprehensive than the previous regulations were. Understanding what the MDR is, changes to the regulations, and what to expect can help your company get prepared and stay compliant in the future.

The Medical Device Industry is Undergoing a Time of Rapid Growth

The industry in Europe is expected to reach $61.4 billion by 2025, up from $48.9 billion in 2020. The rules that applied to medical devices are shifting to keep up with that growth and the resulting innovation.

What is the EU MDR?

The European Medical Device Regulation is an entirely new set of standards that outlines rules around the production and distribution of medical devices in Europe. The regulations were designed to ensure that companies produce medical devices safely and that potential risks are mitigated. The prior document, the MDD, had roughly 60 pages, compared with the MDR which spans 174 pages. The new document includes a 13-page introduction, 123 articles, and 17 annexes. Additionally, there are 42 implementing acts, which further clarify the MDR, and 12 delegated acts, which modify and amend the regulation.

Understanding the major changes can help you better understand how to stay compliant.

MDD vs. MDR: What’s the Difference?

MDD REGULATIONS: Roughly 60 pages in length and focused heavily on the preapproval stage of medical device management.

MDR REGULATIONS: Includes 174 pages that present a lifecycle approach to regulations. Expanded to include new categories of coverage, such as cosmetic devices, contact lenses, and many others, as well as more rigorous oversight.

To learn more about EU MDR and get a better understanding of the changes being made, download our full EU MDR eBook.


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