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Exploring Regulatory Pathways for Medical Devices in the U.S. & EU

July 6, 2020

The Texas Health CoLab Learning Series supports Austin’s health innovation ecosystem by offering classes, seminars and immersive workshops that are open to all Texas Health CoLab participants as well as the general public. Seminars usually occur the last Thursday of the month and are livestreamed to several locations across Texas.

This post was written by Vandana Dubakula, a Texas Health CoLab intern.

During the virtual Texas Health CoLab Learning Series event in May, Evangeline Loh, Ph.D., RAC (U.S., EU), global regulatory manager at Emergo by UL, shared her knowledge on the regulatory pathways for medical devices in the United States and Europe.

She distinguished between the definitions of medical devices in the two jurisdictions and provided an overview of the regulatory bodies and classification systems. She then went into greater detail on the regulatory systems and approaches to regulatory submissions to provide a holistic understanding of the topic.

Loh began by defining medical devices as physical products intended for use in diagnosis, monitoring or treatment of a disease. While the U.S. and EU have similar definitions of medical devices, there are slight nuances that lead to differing categorizations for products. She illustrated this with the example of an electric toothbrush, which the U.S. considers a medical device and the EU classifies as a toiletry.

Loh then explained how regulatory bodies and classification systems differ between the U.S. and EU.

While the Food and Drug Administration regulates medical devices in the U.S., this responsibility in the EU falls under the European Commission, though the regulations are further defined and enforced by each country’s authority. The EU also uses notified bodies to conduct a conformity assessment for high-risk devices.

Likewise, the device-classification systems vary. Though both categorize medical devices in three classes, the U.S. determines the classification by identifying the regulation number or code, while the EU’s classification is based on rules outlined in medical device regulations.

After providing background on medical device regulatory systems, Loh discussed regulatory requirements and approaches to regulatory submissions. She highlighted that having the foundation for classification is important in order to understand clinical data requirements and determine regulatory strategy.

Loh then outlined the steps for a successful regulatory review. For the U.S., it involves having a record of a 501(k) filing or premarket approval application review based on the medical device class and establishment of registration and listing. Similarly, for the EU, a notified body issues a CE marking certificate and an EN certificate.

To solidify this process, Loh tied it back to the electric toothbrush example. Searching for this product in the 501(k) premarket notification database and looking at the product code provides information about the device’s submission type.

The last portion of Loh’s presentation delved into the benefits of U.S. FDA clearance and CE marking and why they are worth the investment. She explained that devices that receive pre-market approval clearance gain more rapid acceptance by regulatory authorities in various countries. Since the FDA has a wide scope of requirements prior to granting device clearance, manufacturers are more likely to gather extensive information about the safety and performance of the device, which is advantageous for consumers.

Regulatory requirements for medical devices can be complex and vary widely across the globe, but Loh masterfully detailed the differences between the U.S. and EU regulatory systems and shed light on the approaches to regulatory submissions. She used ample examples during the presentation to illustrate the pertinence of what would otherwise just be theoretical concepts. Loh’s comprehensive, informative presentation gave the audience an in-depth understanding of the various pathways to bring medical devices to the market.

View the recording of Loh’s seminar to learn more.

To find out about upcoming seminars and to register, please visit the Texas Health CoLab Learning Series website.