Let’s suppose that, as a manufacturer of Medical Devices, your company has received a complaint from a customer. This is a situation that must be taken into consideration and managed by the manufacturer before it even happens. It shouldn’t come to dealing with a complaint without the necessary procedures in place and without the personnel in charge being available and knowing exactly what to do.

To do this properly, it is necessary to implement a QMS that takes into account the management of complaints, the communication to the Regulatory Authorities and either sending informative notes to customers or the withdrawal of the product from the market.

The correct way consist of investigating the causes, taking the appropriate measures to correct the problem, as defined by the company QMS and the regulations in place in a given country.

Strategies to implement in case of complaints

As we are accustomed to in the field of Medical Devices, the companies operating in the sector must meet and comply with all regulatory requirements in the particular country where their product is marketed.

ISO 13485:2016 and the American cGMP system contain the requirements for the improvement of processes and products. The manufacturer of Medical Devices is required to use feedback from sources such as: complaint management, post-market surveillance, non-compliances management, corrective actions and preventive actions to ensure product and process improvements.

A “complaint” is defined as [21 CFR 820.3 (b)]: “any written, electronic or oral communication that alleges deficiencies related to identity, quality, duration, reliability, security, effectiveness or performance of a device after it has been released for distribution. “. ISO 13485:2016 also adds “… or relating to a service that affects the performance of these Medical Devices”.

In particular, when it comes to customer complaints, it is necessary to refer to 21 CFR 820.198 – Complaint Files (specifically for the American market – FDA) and to ISO 13485:2016: 2016 section 8.2.2 – Complaint Handling (for the European / International market).

The Manufacturer is obliged to keep the complaint files and to have clear and unequivocal procedures for receiving, reviewing and evaluating complaints. These documents must be evaluated according to the current legislation, in a “uniform and timely” manner, in a way that facilitates deciding whether the complaint justifies the notification to the Notified Body in accordance with the requirements of section 8.2.3 of ISO 13485:2016: 2016 and / or 21 CFR part 803 (USA cGMP).

It is therefore mandatory to evaluate any complaints received by an organization from their customers because they represent the most common external indicators of any lack of the product, of malfunctions related to the usability of the product and of problems related to the marketing of the product which will be subject to corrections or corrective actions aimed to prevent the recurrence of the problem.

 Developing a procedure to handle complaints

Having a documented procedure that defines the steps and actions necessary for the universal management of complaints according to regulatory requirements is, for an organization, one of the fundamental steps to progress and improve. Demonstrating that the necessary records and clear procedures are being maintained, is the means to implement this improvement.

The procedures put in place for handling complaints require a broader view of the QMS and a formal appointment of a person who collects and manages all complaints received from customers (in both written and oral form).

To ensure an immediate review of any complaint and to implement the regulatory requirements (in particular, those related to injury, death or other hazards related to operators and patients) it is necessary to have the proper authority, expertise, and one or more designated persons who manage the complaints process.

The designated person may also be external to the company, but the relationship between the parties must be regulated by specific agreements. This process involves, among other things, statistical analysis of the complaints to ensure improvement, CAPAs and their management, management of reports and information notes to customers, etc. There are complex intertwinements among the different organization processes.

Generally, every complaint concerns a specific product of the Organization and must be treated as a singular event – a problem reported by a customer for a single type of product. For example, if a second customer reports a similar problem, this event will be recorded in a separate complaint. Even if a customer reports problems related to multiple products, these will be recorded as separate complaints. These strategies must be defined within the corresponding procedures.

From a company’s point of view, the development of the complaints handling procedure must follow a series of logical steps (and therefore a decisional flowchart), among which we highlight:

  1. decide whether the complaint needs an investigation;
  2. decide whether the event needs to be reported to the competent authorities (Notified Bodies or FDA);
  3. decide whether the complaint requires corrective actions;
  4. assess the extent to which the technical product documentation needs updating.

As an industry operator, no matter how hard keeping complaints to a minimum may be, it is possible that during the lifecycle of a given device, the complaint event occurs. In this case, the company needs to ensure that an appropriate complaint handling procedure is in place and, as a result of the complaint handling process, the company must learn from its mistakes as an improvement strategy.


THEMA - Logo TRASPARENTE_smallIng. Andrea Franceschini
Product Manager – QA/RA Consultant


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