When does a product change for a Class III medical device require National Body (NB) approval?

A product change for a Class III medical device requires National Body (NB) approval when it affects the conformity with essential requirements or conditions prescribed for the use of the product. This is crucial because Class III medical devices are subject to the highest level of regulatory scrutiny due to their potential risks to patients.

When a change impacts conformity with essential requirements, it directly relates to the safety and effectiveness of the device, which are critical for compliance with regulations. Any modification that alters how a device meets these essential requirements necessitates a reassessment to ensure ongoing compliance with established regulatory standards.

Changes that do not directly influence conformity might still be significant in terms of quality or risk, but they do not trigger the same level of regulatory oversight as changes that affect essential requirements. Therefore, understanding the regulatory landscape is vital for manufacturers to ensure that any significant alteration in a Class III device receives the necessary approval to safeguard patient safety and device compliance.