How to Handle the Customer Complaints according to various regulatory frameworks?

About Complaint Handling

As a medical device manufacturer, ensuring product safety and efficacy is not just a commitment but a cornerstone of the ethos of an organization. The safety and efficacy of the product will be ensured by an organization by implementing a proficient Quality Management System (QMS). One crucial part of this QMS is the complaint handling process which needs to be implemented by the medical device manufacturer to address customer complaints, improve product quality, and ensure regulatory compliance. It involves the reception, analysis, and resolution of customer complaints pertaining to the safety and effectiveness of products and services provided by the organization. Quick and effective resolution of complaints is mandatory for medical device manufacturers to ensure customer satisfaction and adhere to regulatory requirements.

Medical device manufacturers who wish to place their products and services in different markets like the United States, Europe, India etc. need to implement a customer handling process as per the applicable regulatory requirements. In the U. S., 21 CFR Part 820, established by the Food and Drug Administration (FDA), lays out the current good manufacturing practice (CGMP) standards for medical device manufacturers. Section 820.198 within this regulation provides detailed and specific requirements concerning the handling of complaints. Similarly, Manufacturers intending to market their products in the European Union are required to comply with the medical device quality standards delineated in ISO 13485:2016. The requirements for customer complaints handling within this standard are outlined in Clause 8.2.2. In this blog, we shall explore What is meant by complaints and their types, different sources, common reasons and how to handle the complaints as per the various regulatory frameworks, including ISO 13485:2016, 21 CFR Part 820 and the European Medical Device Regulation (MDR), and the significance of complaint handling.

What is a complaint?

A complaint is a dissatisfaction of the customer towards the product, service, or process, typically due to perceived shortcomings or encountered problems.

Feedback can take the form of either positive or negative input, offering insights or opinions aimed at improving a product, service, or process. Negative feedback, such as suggestions to enhance product delivery times, is categorized as a complaint.

As per ISO 13485:2016 and FDA 21 CFR part 820 complaint can be defined as:

• ISO 13485:2016: Any 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.
• FDA 21 CFR Part 820: Complaint means any written, electronic, or oral communication that declares deficiencies related to the identity, quality, durability, reliability, safety, effectiveness, or performance of a device after it is released for distribution.

What are the different types of complaints?

Complaints can be differentiated into three types based on the impact of the device on health:

• Critical Complaint: This type of complaint involves the use of a product that has led to serious adverse health consequences or poses a life-threatening risk. Critical complaints are of utmost concern and may necessitate the removal of the product from the market to prevent further harm.
• Major Complaint: A major complaint indicates that the use of the product may result in temporary adverse health consequences. While not as severe as critical complaints, major complaints still require prompt attention and action to mitigate risks to users.
• Minor Complaint: This category contains scenarios in which the product’s usage or exposure is unlikely to result in adverse health consequences. Examples of minor complaints include issues such as short quantity, packaging damage, delayed delivery, or unclear label content. Although less severe, addressing minor complaints is essential for maintaining customer satisfaction and ensuring the product meets quality standards.

What are the different sources of complaint?

There are different sources to submit the customer complaints such as Phone calls, In-person, social media or traditional letters sent by post, e-mail, online contact forms, telephones, and company websites.

What could be the common reasons for complaints?

These are some common reasons for medical device complaints, though they are not limited to these examples:

• Device Malfunction: An insulin pump fails to deliver insulin doses accurately, causing fluctuations in blood sugar levels for diabetic patients.
• Inaccuracy: A thermometer consistently provides readings that are several degrees off, leading to incorrect fever assessments in patients.
• Usability Issues: Nurses find it challenging to adjust settings on an infusion pump due to a non-intuitive interface, resulting in delayed medication administration.
• Delivery Delays: A shipment of vital signs monitors is delayed to a hospital, resulting in shortages during a surge of patient admissions.
• Sterility Concerns: Reports of surgical gloves packaged with holes or tears, potentially exposing healthcare workers to bloodborne pathogens.
• Battery Life Problems: A portable defibrillator’s battery drains rapidly, making it unreliable during emergency situations.
• Product Durability: A wheelchair’s frame cracks under normal use, posing a safety risk to the user and requiring early replacement.
• Adverse Reactions: Patients develop rashes and skin infections from the adhesive used in a continuous glucose monitoring patch.
• Incorrect Labeling: A medical syringe is labeled with the wrong dosage markings, leading to incorrect medication dosing and potential patient harm.
• Software Issues: Errors in the software of a hospital information system lead to incorrect patient records being accessed by medical staff, potentially compromising patient care.

What are the regulatory requirements for medical device complaints handling?

ISO 13485: 2016:

• Clause 7.2 of ISO 13485 emphasizes the importance of customer-related processes by stating in clause 7.2.3 that organizations must establish systems that include “communication with customers in relation to product information, handle inquiries, contracts, and orders (including any changes), manage customer feedback (including complaints), and issue advisory notices”. According to this clause, organizations are required to record customer feedback, review the feedback, and enhance their product and service quality accordingly, thereby increasing customer satisfaction.

• Clause 8.2.1 of ISO 13485 states that organizations are required to establish the procedure for feedback to gather information from both production and post-production activities, and this can be used as input for risk management, monitoring product requirements, and improving product realization processes.

  Clause 8.2.2 of ISO13485 states that organizations have to establish a documented procedure timely handling of complaints, aligned with relevant regulatory requirements. These procedures should outline responsibilities for:

  • Receiving and recording complaint information,
  • Evaluating whether received feedback qualifies as a complaint,
  • Investigating complaints thoroughly,
  • Deciding whether to report complaint information to regulatory authorities,
  • Managing complaint-related products,
  • Determining the need for corrections or corrective actions.

If a complaint is not investigated, there must be documented justification.

21 CFR Part 820:

The 21 CFR Part 820, mandated by the United States Food and Drug Administration (FDA), outlines the quality system regulation and the Current Good Manufacturing Practice (cGMP) requirements for companies involved in the production of medical devices.

According to Section 21 CFR 820.198 of the regulations, manufacturers are required to keep complaint files and set up processes for receiving, reviewing, and assessing complaints via a designated unit.

21 CFR Part 803:

The FDA regulation known as 21 CFR Part 803 sets forth criteria for medical device reporting. According to this regulation, incidents involving deaths and serious injuries related to medical devices must be reported to the FDA. The primary objective of this regulation is to ensure prompt notification to the FDA of any serious adverse events linked to medical devices.

Section 21 CFR 803.18(d) of the regulation specifies that medical device companies are required to establish and uphold procedures for documenting device complaints.

MDR and IVDR:

The European Union has established two regulations, the Medical Device Regulation (MDR) and the In Vitro Diagnostic Regulation (IVDR), which outline the regulatory requirements for medical devices and in vitro diagnostic medical devices, respectively. These regulations are designed to ensure that devices comply with safety, performance, and quality standards.

Article 87 of these regulations mandates that manufacturers submit vigilance reports, which involve collecting, assessing, and reporting incidents and corrective actions related to medical devices. Any incidents resulting in death, serious injury, or unexpected deterioration in a patient’s health must be promptly reported to the relevant authorities.

Feedback and complaints are essential components of the post-market surveillance plan outlined in Annex III of the MDR and IVDR. Post-market surveillance (PMS) involves monitoring the safety and performance of medical devices after they are placed on the market to identify and address potential safety issues. The post-market surveillance plan should detail effective and appropriate methods and tools for investigating complaints.



Below are the examples of PMS data mandated to be gathered and addressed according to MDR and IVDR.

• Reports detailing significant incidents.
• Insights gathered from corrective actions in the field for safety.
• Documentation of incidents considered non-severe.
• Data concerning any adverse effects observed.
• Analysis derived from trend reports.
• Data sourced from specialized or technical literature, databases, and registers related to the medical device.
• Feedback and complaints provided by users, distributors, and importers.
• Publicly accessible information regarding similar medical devices.
• Insights extracted from periodic safety update reports (PSURs).

What essential information should be included in a customer complaint regarding a medical device?

When a complaint is received from a customer, there is some specific information that needs to be mentioned. Specifically:

• Date: The date of the event, which may differ from when it was reported.
• Place: Where the event occurred.
• Event Description: Details of what happened, including any failure or potential failure.
• Medical Device Information: All details needed to identify the medical device involved.
• Patient Involvement: Any information about the patient involved, including the consequences of the event and whether there was any medical intervention.

These are the essential information about the complaint required to conduct an initial evaluation. Sometimes, contacting the customer is necessary to gather all the required details.

Schematic of How to Handle Customer Complaints:



Benefits of Complaint Handling?

A well-structured complaint-handling process offers numerous advantages for both companies and customers.

• Regulatory Compliance: Having an effective complaint handling system helps companies comply with standards like ISO 13485:2016, MDR, and 21 CFR Part 803 and 820.
• Improved Product Quality: A robust complaint-handling process helps identify and prevent recurring issues, leading to enhanced product quality and safety.
• Increased Customer Satisfaction: By promptly addressing customer complaints, companies show their commitment to customer happiness. This responsiveness improves customer loyalty as clients appreciate having their concerns heard and resolved quickly. This builds trust and strengthens the company’s reputation.
• Cost Reduction: Analyzing and acting on customer feedback helps companies avoid future complaints and associated costs. Early detection and correction of product issues can prevent expensive recalls, saving on withdrawal, notification, and replacement expenses.