Is it a medical device?
Is this product a medical device?
In the world of healthcare, patients and healthcare professionals rely on a vast array of equipment, but not everything they use is a medical device.
Understanding what constitutes a medical device is important:
- For innovators and manufacturers, it determines key aspects of product development and market access, including regulatory oversight, reimbursement pathways, and marketing, sales, and service obligations.
- For users, including healthcare professionals and providers, it ensures they are procuring and using the right products for the right purposes.
Misinterpreting whether a product is a medical device can lead to significant legal, financial, and reputational risks�“and, most importantly, it can harm users or patients.
The Medical Device Qualification Toolkit
Determining whether a product meets the regulatory definition of a medical device is called qualification.
The MedDev Central Qualification Toolkit is a simple spreadsheet containing the medical device definitions for 10 major markets:
- European Union (EU)
- United States of America (U.S.A)
- Canada
- United Kingdom (U.K.)
- Australia
- Japan
- China
- Brazil
- New Zealand
- South Africa
The toolkit also lists the regulator and guidance documents relevant to medical device qualification.
Features and Benefits
Easy to Use
Breakdowns for medical device and IVD definitions across major markets.
Industry-Standard
Compiled by industry experts and regularly updated to reflect regulatory changes.
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Don’t risk misclassification! Learn what makes a product a medical device using the MedDev Central Qualification Toolkit.
