Complaints can come from anywhere. Although they cannot be fully eliminated, they can be greatly minimized. If they can't be stopped, they can be efficiently handled. And this requires a good comprehension of the complaint handling fundamentals. This article will help you comprehend and effectively handle them from the opening through the closing of the complaint.
In the medical device industry, complaint handling involves much more than soothing dissatisfied customers. It is a regulatory requirement and a risk-reduction essential.
Understanding Complaints
FDA 820.3
"Complaint means any written, electronic, or oral communication that alleges deficiencies related to the identity, quality, durability, reliability, safety, effectiveness, or performance of a device after it is released for distribution."
ISO 13485:2016
"Written, electronic or oral communication that alleges deficiencies related to the identity, quality, durability, reliability, usability, safety or performance of a medical device that has been released from the organization's control or related to a service that affects the performance of such medical devices."
Complaints are a one-way process. They come in and hence handling them is a reactive process rather than a proactive process. Those involved in the complaint handling process will find reading the 21 CFR Part 820 and ISO 13485:2016 very useful. Also, this seminar sheds valuable insights about the topic.
Differentiating between Complaint and Feedback
A complaint can be feedback. But feedback cannot be a complaint. It is important to understand the difference between feedback and a complaint because you need to set a process for complaints to meet your requirements. You will understand more about it in the latter part of this article. Inquiries about the product, call for preventive maintenance, shipping error, and cosmetic defects are not complaints.
Turning Complaints into Opportunities
Rather than viewing the complaint-handling process as a burden, leading medical device companies highly value them. The data complaints generate helps them develop better, safer products, lower labor costs, and reduce plant downtime. A well-designed complaint capture system is one of the most valued means to monitor the quality of the product and provide feedback to the design, manufacturing, technical support, sales, and marketing teams. Such a system holds a key part of a complete responsive customer service solution and is an important component of risk management.
Sources of Complaints
Complaints can come from various sources and may be submitted by customers or from customer service staff, your sales team, or frontline representatives.
- Telephone
- Online forms
- Email
- Social media
- Online product reviews
- Letters
Whatever the source of the complaint may be, it is important for complaint handling staff to be well equipped to handle complaints in accord with the regulatory requirements. (21 CFR Part 803).
Classifying Complaints
The post-market complaints can be classified into two baskets:
- Incident-driven: An incident such as serious harm or death occurred due to malfunction of the device will require immediate attention.
- Review-driven: When reviewing your data, if a pattern of repeated failures or flaws which qualifies as a complaint are noticed, it can be categorized as a review driven complaint.
Setting up a Process to handle complaints effectively
- FDA 21 CFR 820.198 and ISO 13485:2016 section 8.2.2 provides regulatory requirements about medical device complaint handling.
- As per the requirements, you must have a formally designated unit with clear procedures to receive, review, and evaluate complaints
- They must be investigated in a consistent and timely manner
- You must evaluate whether a complaint warrants reporting to regulatory bodies under FDA 21 CFR Part 803 and/or ISO 13485:2016 section 8.2.3 requirements.
- Your process for complaint management is something that auditors look for when you are inspected.
- Warning letters will be issued if complaint procedures are not in place. Your complaint handling process must be properly documented.
How the FDA expects you to develop and implement proper handling of complaints reportable or non-reportable, product complaint handling and documentation is, is covered in detail here.
A typical Complaint handling process example
Investigating the complaint
Step 1: Evaluate whether the complaint is valid or potentially reportable
Section 820.198(b) discusses the initial review and evaluation of the complaints in order to determine if the complaints are "valid." this evaluation is not the same as a complaint investigation. The evaluation is performed to determine whether the information is truly a complaint or not and...whether the complaint needs to be investigated or not. If the evaluation decision is not to investigate, the justification must be recorded. - QS Preamble, Comment 190
Review, evaluate and investigate any complaint involving the possible failure of a device, labeling, or packaging to meet any of its specifications, unless such investigation has already been performed for a similar complaint and another investigation is not necessary - 21 CFR 820.198(c)
Step 2: Investigate the probable cause
Step 3: Investigate to root cause where possible
Closing the complaint
After taking appropriate actions, your system may let you close the complaint.
At each step of the investigation process, ensure that you document parallel processes such as vigilance reporting, updating of risk management files, and CAPA if relevant. If your investigation came to an end at the first step, you are required to document that further investigation was not required and the reason for ending the investigation. The same holds good at whatever stage the investigation ends.
If your investigation reached the final stage where you prepare a CAPA, your process may let you end the complaint by providing a reference to the continuing of the CAPA work. This is valuable because you may have received more complaints about the same problem before the CAPA are executed.
FAQs on Medical Device Complaint Handling
1. What qualifies as a “complaint” for a medical device manufacturer?
A complaint is essentially any written, electronic or oral communication that alleges a device has failed to meet its specifications, or has malfunctioned, and one expects the manufacturer to take action. Even if the device has passed its expected lifespan or was used in an unintended way, if the user says something didn’t work — log it as a complaint, investigate, and then determine next steps.
2. How should complaints be classified and why is it important?
Classification matters because not all complaints are equal. You’ll often categorise them by severity (critical vs minor), by regulatory reportability (reportable vs non-reportable), and by type (mechanical failure, software issue, labeling, etc.). Proper classification ensures you prioritise correctly, meet regulatory obligations (e.g., 21 CFR 820 in the US), and support trend-analysis and quality improvement.
3. What key steps should a manufacturer follow once a complaint is received?
The typical workflow:
- Intake & acknowledgement of the complaint.
- Triage/initial risk assessment to decide how urgent it is.
- Investigation & root-cause analysis (including if it needs correction, redesign, etc).
- Decide if regulatory reporting is required (e.g., adverse event, recall).
- Implement corrective and preventive action (CAPA) if needed.
- Document everything and close out once all required follow-up is done.
- Review trends to find recurring issues and assess effectiveness of your actions (Verification of Effectiveness).
4. What are the typical pitfalls or problems companies face in complaint handling?
Some common ones:
- Incomplete or unclear intake information (makes investigation hard).
- Misclassification of complaints (leading to missed regulatory reporting).
- Poor linkage between complaints and CAPA/risk management systems (so root-causes aren’t addressed).
- Outsourcing complaint handling without maintaining oversight (losing control over timeliness, data integrity).
- Not analysing complaint data for trends (treating each complaint as isolated rather than as a signal).
5. When does a complaint trigger regulatory reporting (for example to the U.S. Food & Drug Administration)?
If your investigation suggests the device caused or contributed to a serious injury or death, or has malfunctioned in a way that would likely cause serious injury or death if it recurred — then yes, it's likely reportable under regulations such as 21 CFR 803 in the US. The manufacturer must evaluate complaints to determine if they meet those criteria and must have documented procedures for this.
6. Can a product outside its labeled life-span still result in a complaint investigation?
Yes – usage beyond labeled life or expiry doesn’t automatically exclude it from being a complaint. The key question is did the device fail to perform as intended or present a risk? If yes, investigation is required. Many experts err on the side of caution and record it as a complaint and then decide investigation depth.
7. How should complaint data be used beyond regulatory compliance?
Complaint data can be a strategic asset. Instead of just filing it, you can use it for:
- Identifying trends or patterns (e.g., a particular component failure repeatedly).
- Feeding into design improvements or manufacturing process changes.
- Benchmarking your performance (e.g., complaint resolution time) against industry.
When handled proactively, complaints become a pathway to improved product quality and reduced risk, not just a compliance burden.
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