What should a regulatory professional do when marketing CE-marked devices as a system or procedure pack?

When marketing CE-marked devices as a system or procedure pack, verifying compatibility, labeling, and drawing up a declaration is essential because it ensures that all components function effectively together and meet regulatory requirements. Each device in the system must not only be individually CE-marked but must also be compatible with one another when marketed as a collective unit.

This necessitates a thorough assessment to confirm that the intended use of each component aligns with the overall system or procedure pack's intended use. Compatibility checks are crucial as they dictate that devices work safely and effectively together. Furthermore, proper labeling is vital to communicate the intended use and ensure that users understand how to use the entire system correctly, as the application context may differ from when the devices are used separately.

The declaration aspect is also significant; it provides formal assurance that the system or procedure pack complies with relevant safety standards and regulations. This declaration acts as a critical document in demonstrating compliance to regulatory authorities and market players, thus safeguarding the legitimacy of the marketed system or pack.

Other options do not sufficiently address the complexities involved in marketing CE-marked devices as a system or procedure pack as they overlook the necessity for comprehensive verification and documentation.