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Handling Complaints, Medical Device Reporting (MDR), Recalls, Corrections and Removals effectively


Are you a personnel involved in medical device reporting (MDR) and correction & removal processes? If yes, familiarizing yourself the MDR and recall compliance are critical to your professional development and continued survival of medical device Company you serve.

The FDA continues to issue numerous warning letters and enforce serious actions, including criminal and civil penalties on Companies that lack proper reporting, corrective and removal actions. Since the past three years, there is a steep increase in the number of medical device companies having their recall as a most severe (class 1) recall. Also, as a result of failing to properly report and take corrective action, Companies face severe product liability and financial risks.

Managing Your Complaints and Obstacles in Post-Market Requirements aright requires you to have the right tools. This article will help you create and maintain effective procedures for handling complaints, report events, and recalls.

Complaint Handling Process

Complaint handling is a key component of the overall quality system. Product safety assurance is an ongoing process that consists of development, surveillance, correction and improvement and monitoring resulting in a higher level of product quality.

Complaints have to be dealt with. Complaint handling is the only quality process where you directly interact with the customer. To get to know the requirements for complaint handling, refer to FDA 21 CFR 820.198 and ISO 13485:2016 section 8.2.2.

To prevent complaints

  • Have an adequate complaint handling procedure in place
  • Implement a proper management strategy for tracking and monitoring all complaints that may come in from several sources like phone, email, snail mail, forms on the company's website or social media. Make sure that noting slips through the cracks across multiple channels
  • Follow the complaint procedures which are in place
  • Follow through and close complaints in a timely manner
  • Report device-related adverse events and product problems to the FDA

Stabilizing the complaint handling process:

  • Ensure you have a centralized complaint management process as part of your overall quality management system. Don't let complaints fall through the cracks.
  • Ensure your complaint handling staff receive appropriate training
  • Dedicate a good amount of the management time to ensure complaints are prioritized
  • Ensure adequate resources to manage and investigate complaints

The Importance of MDR

Despite best intensions, sometimes things go wrong and an important part of the process is to identify issues and take preventive measures for future. The intension of the FDA's MDR guidance is to ensure any issues that do occur are reported as a direction for post market surveillance.

The purpose is to also to ensure that the safety and efficacy of the device are maintained by reporting incidents in a timely manner.

medical Device Reporting

What should you report?

Anything that could cause death, serious injuries and malfunctions should be reported. But, you should also understand the relationship between your device and the adverse event. Did the event really occur because of your device?

You don't have to report a compliant concerning a possible MDR event if:

  • If you have ample evidence to conclude that the adverse event did not cause death or injury
  • If the information you received is erroneous
  • If you did not manufacture the device
  • If you have received the information from multiple sources. One report is required for the event when first reported.

If you are unsure, report it anyway. Over-reporting is fine, underreporting can land you in trouble. If you do report, it demonstrates that your quality systems are working. Reporting even when in doubt provides an opportunity to learn something and make improvements.

Is MDR and complaint the same?

Although an MDR is often a complaint, it doesn't necessarily always be a complaint. Neither is a complaint always suitable to be classified under the MDR category. An MDR could be a sub category under complaints that are design or user-related.

How soon should you report?

It depends on the severity of the issue. If the problem is very severe and could potentially affect many people, it should be reported soon as possible.

The mandatory reporting Requirements for Manufacturers and Importers.

The timelines are

For Manufactures

  • Within 30 calendar days of becoming aware of an event such as deaths, serious injuries and malfunctions
  • Within 5 work days of becoming aware of an event that is designated by FDA or an event that requires remedial action to prevent an unreasonable risk of substantial harm to the public health

For Importers

  • Within 30 calendar days of becoming aware of an event such as deaths and serious injuries
  • Within 30 calendar days of becoming aware of an event such as malfunctions

What counts in as a manufacturer?

'Any person who manufactures, prepares, propagates, compounds, assembles, or processes a device by chemical, physical, biological, or other procedures. The term includes any person who:

  • Repackages or otherwise changes the container, wrapper, or labeling of a device in furtherance of the distribution of the device from the original place of manufacture to the person who makes final delivery or sale to the ultimate user or consumer;
  • Initiates specifications for devices that are manufactured by a second party for subsequent distribution by the person initiating the specifications; or
  • Manufactures components or accessories which are devices that are ready to be used and are intended to be commercially distributed and are intended to be used as is, or are processed by a licensed practitioner or other qualified person to meet the needs of a particular patient.'

Who counts in as an importer?

  • Importer is any person who imports a device into the United States and who furthers the marketing of a device from the original place of manufacture to the person who makes final delivery or sale to the ultimate user, but who does not repackage or otherwise change the container, wrapper, or labeling of the device or device package.

Click here to understand EU Medical Device Regulation (MDR) - Updated CE Marking Process and ISO 13485:2016 Expectations.

Recalls, corrections, and removals

Voluntary recalls

'Recall is a voluntary action that takes place because manufacturers and distributors carry out their responsibility to protect the public health and well-being from products that present a risk of injury or gross deception or are otherwise defective. To understand how to conduct an effective recall, refer to 21 CFR 7

Mandatory recalls

In rare instances, where the manufacturer or importer fails to voluntarily recall a device that is a risk to health, FDA may issue a recall order to the manufacturer under 21 CFR 810, Medical Device Recall Authority.

What should you report?

Refer B'806.10(c) for a list of 13 points to report

How soon should you report?

Within 10 working days from the time the firm initiates the correction or removal.

To minimize risk of regulatory enforcement actions pertaining to Post-Market activities, Complaint Handling, MDRs, and Recalls, attend the seminar Managing Your Complaints and Obstacles in Post-Market Requirements -- Results from Top Medical Device Observations During an Inspection. This Seminar will help you stop spinning your wheels with nonessential activities, and leave you with a comprehensive learning package that only Rita Hoffman, a former FDA CDRH Recall Branch Chief with experience across the device, drug and veterinary industries can provide.