Classification of medical devices

Medical devices are classified based on their intended use, complexity, and potential risk to patients and users. This classification is crucial because it determines the regulatory requirements a device must meet before it can be marketed and used in healthcare settings.

Classification helps manufacturers understand the regulatory pathway early in the development process.

EUUS

• MDCG 2021-24 Guidance on classification of medical devices

• Medical device classification - FDA overview
• The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)] Guidance for Industry and Food and Drug Administration Staff