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Medical Device Development: Pathways to Approval in the U.S. and the EU

Introduction

Although medical device development is similar in many ways to drug development, devices are subject to different regulatory requirements and approval pathways than drugs. There are also key differences in the rules for the clinical investigations needed to support marketing approval, in part due to the durable nature of devices, which may be implanted in patients’ bodies for extended periods. Understanding where the development pathways for devices and drugs diverge is a critical first step in ensuring proper planning throughout the medical device development process, from discovery to post-market surveillance.

In this white paper, we explore the development process, regulatory landscape, and pathways to approval for medical devices to help sponsors optimize the likelihood of commercial success.

Key distinctions between devices and drugs

Fundamental differences between medical devices and drugs contribute to differences in the development of —and regulatory process for —medical devices. While drugs are designed to act therapeutically by pharmacological, immunological, or metabolic means, devices can act in multiple ways on the human body, depending on their purpose. A device may be therapeutic or diagnostic in nature, or it may be designed for another medical purpose. A medical device may have multiple components — including hardware, software, and/or medicinal constituents — that work in concert to achieve its intended purpose. It may require multiple clinicians to work together to ensure it is administered, applied, or implanted properly.

Unlike drugs, most of which have a similar mode of action and are usually metabolized by the body, medical devices vary significantly in their complexity, mode of action, and purpose, and they may even remain with or be implanted in a patient’s body on a permanent basis. This can result in additional risks, such as device malfunctions or long-term adverse effects. Due to this variability and complexity, medical devices are classified according to their inherent risk to patients and users. The higher the potential risk of a medical device is, the greater the regulatory scrutiny it will face. This risk classification concept is another distinction between medical devices and drugs, and it can have a significant impact on the device development process and the data required for market approval.

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