What is the Difference Between MDD and MDR (in the EU)?
For over two decades, the Medical Devices Directive (MDD) regulated the approval and sale of medical devices within the European Union. However, the introduction of the Medical Device Regulation (MDR) in 2017 marked a significant evolution in how medical devices are assessed and marketed in Europe. Understanding the key differences between MDD and MDR is essential for U.S.-based companies aiming to enter the European market, as MDR imposes a more rigorous framework to ensure patient safety and device effectiveness.
Scope of Application: MDR vs. MDD
One of the most notable differences between MDD and MDR is the scope of regulation. Under MDD, the regulatory framework focused on devices with a specific medical purpose, such as diagnosis, prevention, monitoring, treatment, or alleviation of disease. However, MDR expanded the scope to include devices that may not have a direct medical purpose but could still pose safety risks. This includes items like cosmetic contact lenses, dermal fillers, and products used for cleaning or sterilizing surgical instruments.
The broader scope under MDR means that U.S. manufacturers whose products previously fell outside the MDD framework now need to ensure compliance with the new regulation.
Device Classification Changes
MDR also introduces a more detailed and comprehensive classification system based on the risk a device poses to the user. The classification system under MDD was less stringent and allowed some higher-risk devices to be marketed without thorough evaluation. Under MDR, all devices must undergo a more robust classification process, and higher-risk devices (Class IIb and Class III) face stricter scrutiny.
For example, software used for diagnostic or therapeutic purposes, which may have been classified as low-risk under MDD, is now often classified as higher-risk under MDR. This change is particularly relevant to U.S. companies in the digital health sector, as they may need to conduct additional clinical investigations to meet MDR’s higher standards.
Stricter Requirements for Clinical Evidence
Under MDD, manufacturers could often demonstrate safety and efficacy by drawing equivalence to an existing device on the market. MDR, however, demands clinical evidence that directly supports the device in question, particularly for higher-risk devices. For Class III and implantable devices, manufacturers must provide clinical investigations, which are reviewed by Notified Bodies and, in some cases, by an independent expert panel.
This shift has profound implications for U.S. manufacturers, especially those developing new technologies or complex devices. Clinical evaluations under MDR must be more comprehensive, and equivalence to other devices is only permissible in very limited circumstances.
Post-Market Surveillance and Vigilance
Both MDD and MDR require manufacturers to implement post-market surveillance (PMS) systems, but MDR significantly tightens these requirements. Under MDR, manufacturers are obligated to submit periodic safety update reports (PSURs) and post-market clinical follow-up (PMCF) plans for higher-risk devices.
The goal of these enhanced PMS requirements is to ensure that devices continue to perform safely and effectively after they enter the market. U.S. companies must build systems that continuously monitor device performance, track adverse events, and report any issues promptly to European authorities.
The Role of Notified Bodies
Another key difference between MDD and MDR is the role of Notified Bodies. Notified Bodies are third-party organizations responsible for assessing the compliance of medical devices. Under MDD, Notified Bodies were often subject to less stringent oversight. MDR now places more robust requirements on Notified Bodies, ensuring that only those with the necessary expertise and capabilities can perform conformity assessments for high-risk devices.
The result is a more rigorous review process, especially for Class IIb and Class III devices, making it more challenging for manufacturers to achieve CE marking without providing detailed clinical and technical documentation.
How U.S. Companies Can Adapt
For U.S. companies, the transition from MDD to MDR means navigating a significantly more complex regulatory environment. Companies must be prepared to invest in additional clinical research, engage with Notified Bodies early, and develop comprehensive post-market surveillance systems.
Conclusion
MDR represents a significant regulatory upgrade over MDD, addressing the growing complexity of medical technologies and the need for greater transparency and safety. While the path to compliance is more challenging, meeting MDR standards positions U.S. companies to tap into the expansive EU market with products that reflect the highest standards of safety and performance.
