What is required for all medical devices to ensure compliance?

All medical devices must have comprehensive technical documentation to ensure compliance with regulatory requirements. This documentation serves as a critical foundation that demonstrates a device's conformity to applicable standards, directives, and regulations.

The technical documentation typically includes details such as design, manufacturing processes, risk management, and clinical evaluation data. It helps regulatory authorities assess whether the device meets safety and performance requirements before it can be placed on the market.

Other options, such as an EC type examination certificate and NB involvement, pertain to specific processes that may apply to certain categories of medical devices or specific regulatory frameworks but do not represent a universal requirement for all medical devices. Similarly, multilanguage labeling may be necessary for market-specific requirements but is not a fundamental requirement for compliance across all medical devices. Therefore, the need for technical documentation stands out as the essential requirement for ensuring compliance with medical device regulations.