Which documentation is required for all medical devices?

Technical documentation is essential for all medical devices as it serves to demonstrate that the device meets applicable regulatory requirements. This documentation provides a comprehensive overview of the design, manufacturing processes, intended use, safety, and performance of the medical device. It typically includes detailed information on the device's specifications, risk management, usability studies, and post-market surveillance.

The requirement for technical documentation ensures that manufacturers have conducted thorough evaluations and validations to confirm that their devices are safe and effective for patients and users. Regulatory bodies require this documentation as part of the submission process for market approval to uphold the safety and efficacy standards for medical devices.

In contrast to technical documentation, the other options serve specific purposes but are not universally required for all medical devices. For instance, an EC type examination certificate is specific to devices assessed under certain European regulations, multilanguage labeling pertains to marketing and user information requirements, and NB (Notified Body) involvement may be required based on the classification of the device but is not universally necessary for all medical devices. Therefore, technical documentation is the most fundamental requirement that applies across the board to all types of medical devices.