Under ISO 13485:2016 Clause 8.3, the topic of Control of Nonconforming Product is referenced. This clause is critical for ensuring that medical devices that do not conform to specified requirements are identified, controlled, and prevented from unintended use or delivery.

Relation to EU MDR / IVDR: Under EU regulations, nonconformities can trigger:

• Field Safety Corrective Actions (FSCAs)

• Reporting obligations to competent authorities (e.g., vigilance)

ISO 13485 supports MDR compliance by enforcing traceability and post-market control mechanisms.

ISO 13485 encompasses all stages of the medical device lifecycle, including controlling nonconforming products. The word nonconforming products men’s devices/components/accessories or medical devices that fail to meet specified requirements, such as those set by inhouse standards, customers or regulations. Prompt identification of such nonconformities is essential. Additionally, ISO 13485:2016 outlines the procedures for managing non-conformities in a medical device, even post-use or delivery.

The goal is to identify, segregate and move to other dedicated areas before they get mixed up with good items