Medical device companies that market their devices in Europe or the United States must establish a customer complaint handling process to comply with regulatory quality standards. In the U.S., medical device quality systems are regulated by 21 CFR Part 820, the medical device quality system regulations. Medical device manufacturers can find the full requirements for complaint handling under 21 CFR Part 820.198.
Medical device manufacturers that wish to sell their products within the European Union must conform to the medical device quality standards established in ISO 13485:2016. The guidelines for complaint handling under this standard are described in Clause 8.2.2.
Medical device companies must keep records of all customer complaints they receive. They must establish and document procedures for receiving, reviewing and evaluating customer complaints. The customer complaint handling process should ensure that complaints are processed in a timely manner, that oral complaints are documented upon receipt and those customer complaints are reported to the FDA when required under 21 CFR Part 803.
Medical device companies must review all customer complaints received to determine whether a formal investigation, known as a CAPA, into the complaint should be initiated. When an investigation is deemed unnecessary, the company should document why that decision was made and who made it.
When a medical device company receives a complaint that involves the possible failure of a device, labeling or packaging, they’re required to review, evaluate and investigate the complaint. One exception to the rule is if a previous investigation has already been conducted for a similar complaint, then initiating a new one would be unnecessary.
The significant adverse event reporting requirements for medical device manufacturers are codified under 21 CFR Part 803. When a medical device company receives a complaint that must be reported to the FDA under 21 CFR Part 803, the company must conduct an investigation to determine:
This information must be maintained in a separate section of the complaints file, or be otherwise clearly identified.
FDA requires that medical device companies establish a formally designated unit to manage the customer complaint handling process. This unit will be responsible for conducting investigations of customer complaints and documenting those investigations in compliance with 21 CFR 820.198(e). Records of investigation must include:
FDA mandates that when the formally designated unit for investigating customer complaints is located off-site of the manufacturing facility, customer complaint records must still remain accessible for the manufacturing establishment. Even medical device companies who process complaints outside of the United States must make a copy of their records accessible in the United States.
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