What does CE marking signify for medical devices in Europe?

CE marking signifies that a medical device complies with essential health, safety, and environmental standards required by the European Union. This marking indicates that the device has undergone a conformity assessment process which ensures that it meets all relevant European directives and regulations, particularly concerning safety and performance.

The presence of the CE mark assures both users and regulators that the device is fit for its intended use and that it adheres to the stringent requirements that protect consumer safety and health. The CE mark is essential for placing a medical device on the market in Europe, as it indicates to customers and healthcare professionals that the product has met the necessary regulatory standards.

In contrast, while compliance with international clinical trial standards is crucial for conducting studies, it does not directly relate to the CE marking process. Economic viability is important for market entry but does not pertain to safety and performance compliance, and while healthcare professional endorsement may enhance a product's marketability, it is not a formal regulatory requirement associated with CE marking. Thus, the correct option directly highlights the core purpose of CE marking in the context of medical device regulation in Europe.