The Application Form for Classification of Medical Devices is a formal document submitted to a regulatory authority for the purpose of determining the appropriate classification of a medical device. This classification is based on factors such as intended use, risk level, duration of contact with the body, and the mode of operation.

Purpose The form ensures that medical devices are accurately categorized into the correct risk class (e.g., Class I, II, III or Class A, B, C, D) according to applicable regulatory frameworks such as the FDA, EU MDR, or national guidelines. This classification determines the regulatory controls required before the device can be legally marketed.

Key Information Included

• Manufacturer or applicant details
• Device name and model
• Intended use and indications
• Risk assessment and classification rationale
• Supporting technical documentation

Importance Accurate classification is critical for ensuring patient safety, regulatory compliance, and appropriate oversight. It also guides the level of clinical evaluation, conformity assessment, and post-market surveillance required for the device.