Medical Device Recalls, MDR Reporting, Imports and Exports, What Manufacturers Must Know

Understanding FDA medical device recalls, Medical Device Reporting obligations and the import and export rules that govern device movement across borders is essential for any manufacturer operating in the United States. These regulatory requirements exist to protect patients and preserve the integrity of the healthcare system, but they also pose operational and commercial risks when misunderstood. A strong grasp of these topics allows organisations to manage compliance confidently and maintain product availability without disruption.

What a Medical Device Recall Is

A medical device recall is an action taken to remove or correct a product that violates FDA laws. The majority of recalls are voluntary and initiated by the manufacturer under 21 CFR Part 7 when a product defect, performance issue or labelling error presents a risk to users. In rare circumstances, if a manufacturer does not act, the FDA may issue a mandatory recall order under 21 CFR Part 810. A recall can involve physical removal from the market or an in-place correction such as software updates, servicing or relabelling. Recalls do not include market withdrawals for minor issues unrelated to regulatory violations, stock recoveries involving devices not yet distributed or routine servicing. Each recall action must be handled in accordance with FDA expectations and supported by traceable decisions that reflect the severity of the risk.

How the FDA Classifies Recalls

Every recall is assigned a classification that reflects the level of health risk. Class I recalls are the most serious and apply when use of the device could result in death or serious adverse health consequences. Class II recalls apply when use may cause temporary or reversible health issues or when the probability of serious harm is remote. Class III recalls apply when use is not likely to cause adverse health consequences. These classifications influence how quickly the manufacturer must act, whether public warnings are needed and what level of follow-up checks are required. The categorisation also affects the scrutiny applied by the FDA, the communication obligations of the firm and the expectations for verifying that the recall is effective.

Building an Effective Recall Strategy

A well-structured recall strategy is essential for managing risk, protecting patients and satisfying FDA obligations. Before considering the elements of a strong strategy, it is important to recognise that recalls require rapid, coordinated action. Organisations must be able to identify the severity of the hazard, the scope of affected distribution and the level of public communication required. A recall strategy must define how the firm will identify affected product, how it will notify consignees, how it will track return or correction progress and how effectiveness checks will be conducted. Communications must be clear, urgent and actionable, explaining the issue, the affected products and the steps customers must take. Depending on risk level, effectiveness checks may require sampling or complete verification. A recall ends only when the FDA determines that all reasonable efforts have been made to remove or correct the affected devices. Having a predefined strategy ensures consistency, reduces delay and supports regulatory confidence.

Corrections and Removals under 21 CFR 806

Manufacturers and importers must report certain corrections and removals to the FDA within 10 working days as required by 21 CFR 806. Reporting is mandatory when an action is initiated to reduce a risk to health or remedy a violation that may pose such a risk. Examples include software updates addressing hazardous malfunctions, repairs that eliminate early failures or removals caused by safety-related design flaws. Even when an event does not require reporting, firms must maintain detailed records. Actions such as routine servicing, market withdrawals and stock recoveries are exempt. Understanding when reporting is required prevents regulatory exposure and allows the FDA to maintain oversight of device safety.

What Medical Device Reporting (MDR) Is

Medical Device Reporting, covered under 21 CFR Part 803, is one of the FDA’s primary postmarket surveillance tools. The FDA receives over two million device-related reports each year. MDRs assist the agency in detecting safety patterns, identifying emerging failure modes and evaluating the benefit-risk profile of devices already on the market. MDRs fall into two categories, mandatory and voluntary. Mandatory reporting applies to manufacturers, importers and device user facilities such as hospitals, surgical centres and nursing homes. These entities must report events in which a device may have caused or contributed to a death or serious injury, or when a malfunction would likely cause serious harm if it recurred. Manufacturers must investigate every event and determine the root cause when possible, then submit MDRs electronically. Voluntary reporting is available to healthcare professionals, patients, consumers and caregivers for serious adverse events, product quality issues, device malfunctions and use errors. These reports are submitted through MedWatch and provide valuable early warning signals for regulators and manufacturers. MDRs do not establish causation but they support safety trend analysis and regulatory decision-making.

Why Recalls and MDRs Matter

Recalls, corrections, removals and MDRs form a connected ecosystem that supports patient safety and regulatory oversight. MDR data helps the FDA detect emerging issues and inform regulatory action. Recall data helps remove or correct unsafe devices already in distribution. Together, these systems support early identification of systemic problems, promote transparent communication with users and reduce risk of harm from defective devices. A proactive approach to both recall management and MDR compliance strengthens the manufacturer’s quality system and protects commercial credibility.

Importing Medical Devices into the United States

Importing devices into the United States requires careful adherence to FDA requirements. Foreign manufacturers must register with the FDA and list their devices via the electronic registration and listing system under 21 CFR Part 807. A United States Agent must be designated to act as a liaison between the establishment and the FDA. Initial importers must register, comply with MDR reporting, fulfil corrections and removals obligations under 21 CFR 806 and comply with any tracking requirements under 21 CFR 821. At the point of entry, the FDA verifies the declared manufacturer, the importer, the device listing status and the premarket submission status. Importers should provide accurate Affirmation of Compliance codes to facilitate quicker entry review. Firms must also understand the boundaries of import for export. While components or subassemblies may be imported for further processing and then exported, finished devices that are not legally marketed in the United States cannot be imported solely for export. Warehousing of unapproved devices under an import for export claim is not permitted. These rules help prevent the distribution of devices that have not met US safety requirements.

Exporting Medical Devices from the United States

Device exporters must comply with FDA requirements and maintain records to demonstrate lawful export. Export certificates can be requested through the CECATS system. Since January 2024, all certificates are issued electronically and can be verified using a QR code via the FURLS Export Certificate Validator. Key certificates include the Certificate to Foreign Government for devices already legally marketed in the United States, the Certificate of Exportability under Section 801(e)(1) for Class I and II unapproved devices intended solely for export, the Certificate of Exportability under Section 802 for certain Class II and III devices not authorised in the United States and the Non Clinical Research Use certificate for research only devices. Other authorisations include Export Permit Letters for certain investigational, banned or unapproved devices and Simple Notifications for exports under Section 802 to Tier 1 countries. Exporters must maintain detailed records under 21 CFR 1.101, including device type, quantity, consignee, export date and proof that the device meets export requirements. Compliance preserves market access and prevents costly delays due to documentation deficiencies.

LFH supports manufacturers and distributors in managing recalls, MDR compliance and cross-border device movements. Our regulatory experts provide structured guidance to reduce operational risk, support market access and ensure alignment with FDA expectations across the full device lifecycle.

FAQs – Medical Device Recalls