Complaints Register

A Complaints Register is a mandatory internal log maintained by manufacturers and other Economic Operator entities to record post-market safety issues. Under EU regulations, compliance does not end when machinery leaves the factory; you must actively monitor its performance in the field. This register tracks customer feedback regarding health, safety, and non-compliance events, serving as a critical tool for post-market surveillance.

For North American exporters, this is often managed in coordination with your EU Authorized Representative. If a user reports a hazard or an accident occurs, it must be logged immediately. This data allows manufacturers to identify patterns of failure or Foreseeable Misuse that were not caught during the initial design phase.

Maintaining this register is not optional. Market surveillance authorities often request to see it during an audit to prove you are reactive to safety concerns. Effectively managing this register demonstrates due diligence and ensures your Technical File remains a living document, updated based on real-world usage data.