Healthcare relies on a vast array of equipment, but not all of it falls under the category of medical devices.
Recognising whether a product is a medical device is essential for manufacturers, buyers, and users alike. It influences every product lifecycle stage, from development and compliance to ongoing management.
Failing to classify a product correctly can lead to severe legal, financial, and reputational risks—and, most importantly, endanger patients or users.
The process of determining whether a product meets the legal definition of a medical device is known as qualification. It involves comparing the intended purpose of a product to the legal definition of a medical device in a particular market.
This free toolkit contains the legal definitions for medical devices in major global markets.
Download now to answer the most important question: Is it a medical device?