From Idea To Market: The Five Stages of Product Development

The process of developing medical devices varies across regions due to distinct regulatory expectations. Each region, such as the EU, USA, and UK, has specific regulatory bodies overseeing compliance, such as the FDA in the United States, the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK, and notified bodies in the EU responsible for CE marking. To successfully commercialize a medical device, developers must adhere to these regulatory requirements specific to each region.

Regardless of location, certain fundamental steps define the medical device product development lifecycle. This article focuses on outlining the essential regulatory obligations that manufacturers must meet when distributing medical devices in the United States. Understanding the classification system for medical devices is crucial as it determines the regulatory pathway and requirements applicable to each device category.