Complaint management refers to the regulated process by which a medical device manufacturer receives, evaluates, investigates, and closes communications regarding alleged deficiencies of a product already released from its control. ISO 13485:2016 defines a complaint as a written, electronic, or oral communication alleging deficiencies concerning the identity, quality, durability, reliability, usability, safety, or performance of a released product or a service affecting its performance. Section 8.2.2 of the standard requires documented procedures for timely processing in accordance with applicable regulatory requirements. The process thus serves as the entry point for a significant portion of the data that feeds vigilance, risk management, and post-market surveillance.
Receipt, Registration, and Initial Assessment
ISO 13485, Section 8.2.2, specifies the minimum components of the procedure: receipt and recording of information, evaluation of information to determine whether the feedback constitutes a complaint, investigation of the complaint, determination of the reporting requirement to the competent authorities, handling of the complaint-related product, and determination of whether corrections or corrective actions are to be initiated.
Practically, the distinction between feedback and a complaint is crucial. Not every user statement is a complaint, but the classification must be documented and based on fixed criteria to prevent it from becoming a silent filtering of inconvenient signals. The initial intake should at least capture the date of receipt, reporter, product identification with batch or serial number, described facts, possible patient or user involvement, and the whereabouts of the affected product.
Obligation to Investigate and Justification for Waiver
The standard requires that every complaint be investigated, and an exception is only permitted if the waiver of the investigation is justified and documented. If the investigation reveals that activities outside the organization contributed to the complaint, the relevant information must be exchanged between the manufacturer and the external party involved. Any correction or corrective action resulting from complaint handling must be documented, and the records of the process must be retained.
A robust investigation therefore requires a retrieval strategy: without the affected product or at least photos, usage data, and test protocols, determining the cause often remains inconclusive. Such cases must be documented as such, rather than being closed with an unsubstantiated hypothesis.
Deadlines and Connection to Vigilance
Regulation (EU) 2017/745 directly links reporting obligations to complaint handling. If the assessment reveals a serious incident or a field safety corrective action, the reporting rules of Article 87 with their specified deadlines apply; statistically significant increases in non-serious incidents and expected undesirable side effects are subject to trend reporting according to Article 88. ISO 13485, in Section 8.2.3, supplements the obligation to maintain documented procedures for authority reporting and the issuance of warnings.
Thus, complaint handling is not an isolated customer service process, but a time-bound regulatory procedure. The time of receipt by the manufacturer or an appointed third party triggers the clock, which is why responsibilities, accessibility, and escalation paths must be clearly defined.
Contributions of Other Economic Operators
Complaints often do not reach the manufacturer first. Importers must, according to Article 13, keep a register of complaints, non-conforming products, and recalls and withdrawals, and promptly forward complaints and reports of alleged incidents received by them to the manufacturer and authorized representative. Distributors, according to Article 14, have the same forwarding and registration obligations towards the manufacturer, authorized representative, and importer.
For the manufacturer, this means that their process must describe the interfaces with these operators, contractually secure forwarding channels, and monitor the completeness of incoming reports.
Distinction from Incident, Non-conformity, and Corrective Action
A complaint is an external allegation; an incident is an actual event with defined regulatory significance and its own reporting thresholds. Complaints can uncover incidents, but many remain technical or logistical claims without patient relevance. Conversely, incidents can become known through other means, such as literature or registries.
A non-conformity concerns the product state and may result from a complaint, but is not itself a communication process. The corrective action, finally, is the response to an identified cause and should not be confused with the handling of the individual case: the individual case is closed, the cause is eliminated, if necessary, in a separate procedure.
Relevance for clinical trials
In clinical investigations of medical devices, two reporting systems run in parallel: the investigation-related safety reporting system for adverse events and product defects, and the manufacturer’s complaint system for products already on the market. If a commercially available product is used as a comparator product or as part of standard care, feedback from the investigation site may affect both systems simultaneously and must be accurately assigned without double-counting.
Therefore, investigation site agreements, the investigation plan, and the safety management plan should define which feedback goes to which recipient, within what timeframe, and with what minimum dataset. Full-service CROs like Mediconomics support sponsors and manufacturers in describing these reporting channels consistently, tailoring training for investigation sites, and ensuring the traceability of assignments for audits and inspections.
Frequently Asked Questions (FAQ)
Is every complaint subject to reporting?
No. The reporting obligation only arises if the assessment reveals a serious incident, a field safety corrective action, or a reportable trend. However, the assessment itself must always be documented.
Can complaints be closed without investigation?
Only exceptionally. ISO 13485 requires that every complaint be investigated; if this is deviated from, the justification must be documented and must withstand scrutiny by auditors.
Can complaint management be outsourced?
Operational activities such as receipt and initial intake can be transferred to service providers. Responsibility for evaluation, investigation, and reporting remains with the manufacturer according to Article 10 of Regulation (EU) 2017/745 and must be secured by contracts, training, and oversight.
Regulatory References
- ISO 13485:2016, Section 8.2.2 — Complaint handling with minimum requirements and responsibilities
- ISO 13485:2016, Section 8.2.3 — Reporting to regulatory authorities and warnings
- Regulation (EU) 2017/745, Articles 87 and 88 — Reporting of serious incidents and trend reporting
- Regulation (EU) 2017/745, Article 13 paragraphs 6 and 8, and Article 14 paragraph 5 — Registration and forwarding obligations
- Regulation (EU) 2017/745, Annex III Section 1.1 — Complaints as a data source for post-market surveillance
