When marketing CE-marked devices as a system or procedure pack, what is the most appropriate initial action for the regulatory professional?

When marketing CE-marked devices as a system or procedure pack, the most appropriate initial action for the regulatory professional is to verify mutual compatibility of these devices, ensure adequate labelling, and draw up a declaration for the intended device system or procedure pack.

This is crucial because when devices are assembled into a system or procedure pack, it is imperative to confirm that the individual components work together effectively and safely. Compatibility among the devices is a regulatory requirement to ensure that the complete system performs as expected without introducing any additional risks.

Additionally, the labelling must be accurate and reflect the intended use of the system as a whole rather than just the individual components. This helps users understand the purpose and safety precautions specific to the system or pack. Drawing up a declaration outlines the manufacturer's responsibilities and ensures that the packaging complies with applicable regulations.

This thorough approach not only adheres to regulatory requirements but also supports patient safety and effectiveness in the use of the device system or procedure pack.