1. Device description and specifications

The first section of the Technical Documentation provides a comprehensive description of the device, covering its trade name, intended purpose, and user population. It includes key details such as its classification, operating principles, risk assessment, and any novel features. The section also outlines traceability information through a Basic UDI-DI or other identifiers, explains its functionality and components, and describes any accessories or compatible products. Additionally, it specifies technical characteristics, raw materials, and configuration variants, ensuring a clear understanding of the device’s design and intended use.

Below, you will find links to information about the documents included in Section 1 of MDR-compliant technical documentation, covering key requirements for device description, specifications, and regulatory compliance.

• 1.1 General description →
• 1.2 Specifications of the device
• 1.3 Intended purpose
• 1.4 Basic UDI-DI
• 1.5 Device classification
• 1.6 Operating principles and mode of action
• 1.7 Previous generations and similar devices
• 1.8 Declaration of Conformity