How to manage medical device recalls and advisory notices according to ISO 13485

Updated: September 22, 2023.

A recall, along with necessary advisory notices, is an important but reactive approach that is used by medical device manufacturers to remove a medical device from the market due to regulatory violation, serious risk of injury, damage, or deteriorating health of the patient. A recall of the product is an effective way to rescue a company from a lawsuit that could result in billions of dollars in claims. Medical device recall activities include the return of a medical device to the supplier, rework on the recalled device by the supplier at the place where it is used or on the supplier’s end, exchanging the device for a defect-free device and destruction of the recalled device, and increasing awareness about the handling of the recalled device with the help of advisory notices.

Recalls are sometimes confused with market withdrawal; however, it should be noted that market withdrawal consists of activities like normal stock rotation or the substitution of an outdated device with the latest updated model. A recall and its advisory notices are only issued where there is a risk of adverse impact from a medical device, and therefore should not be confused with market withdrawal. Advisory notices are issued to distributors, users, and sometimes the general public through regulatory bodies.

What is a medical device recall?

Manufacturers are required to monitor their devices once they are on the market and to report any adverse events or malfunctions to the competent authorities. If a manufacturer becomes aware that their device may pose a risk to public health, they must initiate a recall of the device. This can be done voluntarily or at the request of the competent authorities. A recall can be initiated for a variety of reasons, including issues with the device’s safety, quality, or performance. In general, a recall must be initiated as soon as possible after the manufacturer becomes aware of the issue, in order to minimize any potential harm to patients.

The recall process is covered in section 8.3 of ISO 13485:2016, which outlines the requirements for controlling nonconforming products and handling corrective and preventive actions, including recalls.

This process for medical devices under the Food and Drug Administration (FDA) involves three classes, based on the level of hazard posed by the device. So, what is a Class I medical device recall, and what is a Class II medical device recall? What is the difference between a Class I and Class II recall? And what about Class III?

What are the 3 types of recalls under the FDA?

Class I recalls are issued when there is a risk of serious health problems or death associated with the product. A Class II recall of a medical device is issued when there is a risk of temporary or reversible health problems. Class III recalls are issued when there is unlikely to be any adverse health consequences associated with the product.

What triggers a medical device recall?

To initiate a recall, manufacturers are required to notify the FDA and provide information about the product, the reason for the recall, and the actions that will be taken to address the issue. The FDA will then evaluate the situation and determine the appropriate level of recall.

Under the Medical Device Regulation (MDR) 2017/745, there are no recall classifications. Instead, the manufacturer is required to take the necessary corrective actions to bring the device back into conformity, or withdraw or recall the device, depending on the type, level of severity, and nature of the nonconformity. This means that the manufacturer should assess the risk resulting from the nonconformity and take reasonable steps to address it.

The advisory notice for a medical device is a mechanism for communicating important information about the safety and performance of a medical device to healthcare providers and patients. Under the MDR 2017/745, manufacturers are required to issue an advisory notice if their device is found to have a potential safety issue. The notice must describe the issue and provide medical device recall guidance. The advisory notice is an important tool for ensuring the safety and efficacy of medical devices, and it helps to promote transparency and accountability in the medical device industry. The advisory notice is also part of the ISO 13485 requirement “Reporting to regulatory authorities.”

An advisory notice from the FDA is a warning or guidance issued by the U.S. Food and Drug Administration to communicate potential health risks or safety concerns about a particular product or activity. These notices are typically issued when there is evidence of a significant health risk associated with a product, but the FDA has not yet taken formal regulatory action. Advisory notices may also be issued to provide guidance on best practices or to alert the public to potential scams or fraudulent activities. It is important for consumers to carefully review advisory notices and take appropriate action to protect their health and safety.

Management of medical device recalls

Different departments work in collaboration to manage medical device recalls. The ISO 13485 standard requires companies to report adverse events like recalls to regulatory bodies, distinguish recalled devices from conforming product, and issue related advisory notices for the recall where needed. Companies can manage their recall effectively by taking the following measures:

Formation of a recall committee: Usually, although not explicitly required by the standard, the first step in managing recalls is for top management to appoint a recall committee, which should comprise the GM, Regulatory Affairs (RA) Manager, Quality Assurance (QA) Manager, Production Manager, and Sales Manager. The recall committee initiates the recall and organizes associated activities.

Documentation of a well-defined procedure: The second step after the formation of the committee is to create a well-defined procedure for recalls and advisory notices. The medical device recall procedure needs to identify the process flow for the recall, and identify all responsibilities and roles within the committee.

Process flow for a recall in practice: Recalls can be triggered internally within the organization, or by any external source. In normal industrial practices, these reports of possible recalls are immediately forwarded to the Quality Assurance Manager and the Regulatory Affairs Manager. The Quality Assurance Manager reviews the medical device against the device specifications, whereas the Regulatory Affairs Manager reviews it against the regulatory requirements. Both managers analyze the situation and determine the severity of the reported deficiency, including whether it constitutes a recall or not. Any of the managers can call a meeting of the recall committee. Usually, the production and sales departments are responsible for managing activities related to recalls. These activities include the identification of suspected lots, both internally and externally.

Analysis of the recall report: The recall committee, in a recall report presented by the QA or RA Manager, analyzes the recall situation and decides whether a recall can be avoided or not and, if so, examines the following:

• Magnitude and type of health hazard and medical device recall classification
• Projected depth of the recall
• Method(s) of sending advisory notices to recipients, e.g., email, letter, fax, telephone, or multiple communication channels
• Content of the advisory notices
• Mechanism for checking the effectiveness of the recall

When the above data and information are finalized, the proposed recall plan is communicated to relevant authorities.

Issue of advisory notices: The recall committee makes the final determination as to whether advisory notices must be issued. The advisory notices are sent through a traceable method, such as certified mail. The records of advisory notices are maintained and the effectiveness of advisory notices is monitored.

Protocols for receipt of recalled devices: ISO 13485 requires organizations to physically separate returned recalled products from conforming products. Recalled devices are received from the market by the supply chain department, and are stored in a quarantined area under the supervision of the quality assurance department, where they are marked as recalled products to distinguish them from other, conforming products. Recalled devices are to be noted in a Recall Log that identifies the source, quantity returned, defect, and lot numbers.

Decision for recalled devices: The nonconformities listed in the Recall Log are reviewed critically by the quality assurance and regulatory affairs departments to make a decision. Devices within the scope of the recall can be reworked, destroyed, or substituted according to the decision made as per defined procedures.

Corrective action and preventive action request: Concerning good manufacturing practice, the quality assurance department raises a corrective action and preventive action request when a recall is issued. In this process, the root cause of the defect is addressed and a corrective action is taken by a given deadline, so that such issues will not arise again in the future.

Distinguishing medical device recalls from medical device enhancements

According to the FDA, a medical device recall is defined as a firm’s removal or correction of a marketed device that the agency considers to be in violation of the laws that it administers and against which the agency would initiate legal action, e.g., seizure.

A medical device enhancement, on the other hand, is a modification to a legally marketed device that could significantly affect its safety or effectiveness. The FDA has issued guidance documents to help distinguish medical device recalls from enhancements. The guidance document states that the key factor in distinguishing between these two is the existence of a violation of the FD&C Act or associated regulations enforced by the agency.

Importance of managing recalls and advisory notices

Effective medical device recall management for manufacturers is extremely important. There are examples in the market where recall situations are ignored by companies, resulting in heavy financial losses due to litigation and lawsuits filed by the patients. The loss of reputation can result in an even greater negative impact on the company. Therefore, it is vital for medical device manufacturers and suppliers to manage recalls through an effective system.

With this recall management system, an organization can manage recall situations effectively and minimize the damage incurred through the use of hazardous devices.

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