--- title: FDA Post-Market Requirements: MDR Reporting, Recalls, and Corrections description: FDA postmarket obligations for EU manufacturers: Medical Device Reporting under 21 CFR 803, recalls and corrections under 21 CFR 806, compared to EU vigilance. authors: Tibor Zechmeister, Felix Lenhard category: FDA & International Market Access primary_keyword: FDA postmarket MDR reporting recalls corrections canonical_url: https://zechmeister-solutions.com/en/blog/fda-postmarket-mdr-recalls-corrections source: zechmeister-solutions.com license: All rights reserved. Content may be cited with attribution and a link to the canonical URL. --- # FDA Post-Market Requirements: MDR Reporting, Recalls, and Corrections *By Tibor Zechmeister (EU MDR Expert, Notified Body Lead Auditor) and Felix Lenhard.* > **FDA post-market obligations for device manufacturers live mainly in 21 CFR Part 803 (Medical Device Reporting, abbreviated MDR. Not to be confused with EU MDR) and 21 CFR Part 806 (reports of corrections and removals). If you sell in both the EU and the US, you run two parallel systems that share a data engine but trigger under different rules, follow different clocks, and talk to different regulators.** **By Tibor Zechmeister and Felix Lenhard.** **Note on terminology:** In this post, "MDR" means FDA's Medical Device Reporting under 21 CFR Part 803. Where we mean Regulation (EU) 2017/745 we say "EU MDR" in full. The collision in names is an accident of regulatory history that every dual-market startup has to live with. ## TL;DR - FDA Medical Device Reporting sits in 21 CFR Part 803 and covers manufacturer reports of deaths, serious injuries, and malfunctions. - Corrections and removals (the FDA term for what the EU calls recalls and field safety corrective actions) sit in 21 CFR Part 806. - Recall classification as Class I, II, or III is assigned by FDA based on health hazard, not by the manufacturer. - EU vigilance lives in EU MDR Articles 87-92; concepts overlap with FDA MDR but the thresholds, timelines, and authorities are different. - Dual reporting is not optional. A single event in a dual-market device can trigger FDA MDR, EU MDR serious incident reports, and two separate field safety actions. - A post-market system designed only for the EU will fail its first FDA inspection. A post-market system designed only for the US will fail its first Notified Body audit. ## Why this matters Post-market is where most startups discover they have two regulatory systems, not one. The pre-market work. 510(k), CE marking, QMS certification. Looks mostly parallel. Post-market is where the parallelism ends and the divergence starts. An EU startup gets a complaint from a US distributor about a device failure. The device is CE marked in the EU and 510(k) cleared in the US. The complaint describes a malfunction that could cause a serious injury if it recurred. What happens next? In the EU MDR world, you are on the clock under Article 87 from the moment you become aware. In the FDA world, you are on a different clock under 21 CFR 803. The two clocks start at the same moment, tick at different speeds, and point at different reports going to different regulators. If your SOP covers only one side, you have a non-conformity waiting to happen. And in the worst case, a regulatory enforcement action. ## What FDA actually says (and how EU MDR compares) **FDA Medical Device Reporting. 21 CFR Part 803.** Manufacturers must report to FDA when they become aware of information that reasonably suggests a marketed device may have caused or contributed to a death or serious injury, or has malfunctioned and the malfunction would likely cause or contribute to a death or serious injury if the malfunction were to recur. Reports go through FDA's electronic MDR system (eMDR). **FDA Corrections and Removals. 21 CFR Part 806.** Manufacturers and importers must report to FDA any correction or removal of a device that was initiated to reduce a risk to health or to remedy a violation of the FD&C Act caused by the device which may present a risk to health. Certain market-withdrawal actions without a health risk are exempt but must still be recorded internally. **Recall classification.** FDA classifies recalls into Class I (reasonable probability of serious adverse health consequences or death), Class II (may cause temporary or medically reversible adverse consequences, or remote probability of serious consequences), or Class III (not likely to cause adverse health consequences). The manufacturer proposes an action; FDA assigns the class. **EU MDR vigilance. Articles 87-92.** Article 87 requires manufacturers to report serious incidents and field safety corrective actions (FSCAs) to the competent authorities. Article 88 covers trend reporting. The reporting timelines in Article 87 are tied to the severity: immediately and no later than specific day-count windows after awareness, depending on whether the incident involves serious public health threat, death, or a serious deterioration in health. **The conceptual mapping.** FDA MDR reports map roughly to EU MDR serious incident reports under Article 87. FDA 21 CFR 806 corrections and removals map roughly to EU FSCAs and field safety notices. But the thresholds are not identical. FDA's "malfunction that would likely cause serious injury if it recurred" is broader in some respects than the EU definition of a serious incident. And the EU's trend reporting under Article 88 has no direct FDA counterpart. ## A worked example: one complaint, two clocks A French startup sells a Class IIa reusable surgical instrument under CE marking and has a 510(k) clearance in the US. Their German distributor reports that a clinician in Munich experienced a mechanical failure during a procedure. No patient injury occurred, but the surgeon had to switch instruments mid-procedure. The startup's quality team assesses the complaint. **Day 0. Awareness.** The complaint enters the QMS complaint system. A triage officer opens the case. **Day 1. Hazard assessment.** The team determines that if the failure had happened at a different moment in the procedure, it could have caused a serious injury. They now have two obligations, not one. **EU side.** Under EU MDR Article 87, the team assesses whether this constitutes a serious incident or the kind of event that, had it recurred, could have led to death or serious deterioration in health. They decide it is reportable. The clock under Article 87 is running against a competent authority deadline. **US side.** Under 21 CFR 803, the team assesses whether this is a reportable malfunction. Specifically, whether the malfunction would be likely to cause or contribute to a death or serious injury if it were to recur. They decide yes. They prepare an eMDR submission to FDA. **Day 5. Investigation deepens.** Root-cause analysis points to a supplier issue affecting a batch of 500 instruments in distribution. The team now has to evaluate a field action. **EU side.** They draft an FSCA under Article 89, prepare a Field Safety Notice to distributors and users, and notify the competent authority. **US side.** They prepare a correction or removal report under 21 CFR 806, and begin discussions with FDA's recall coordinator about proposed classification. FDA will ultimately assign Class I, II, or III based on the health hazard evaluation. **Day 30.** Both regulators are now in the loop. The same instruments are being pulled from the same hospitals by the same logistics partner, but under two parallel legal frameworks, with two sets of reports, two sets of closure criteria, and two different definitions of when the action is "complete." The key insight: one event, one physical corrective action in the field, two regulatory workstreams that cannot be collapsed into one. Your QMS has to handle both without forcing your team to invent the process during the crisis. ## The Subtract to Ship playbook The goal is a single internal process that produces two compliant outputs, not two parallel processes that duplicate work and drift apart. **1. Build one complaint intake, two assessment branches.** Every complaint enters one system. At the triage step, the form asks two questions: Is this reportable under EU MDR Articles 87-92? Is this reportable under 21 CFR Part 803? Both questions get answered on every dual-market complaint. Neither branch blocks the other. **2. Write one SOP that references both regulations.** Do not maintain a "European Vigilance SOP" and a "US MDR Reporting SOP" as separate documents. They will drift. Maintain one Post-Market Reporting SOP that has two sections. EU obligations and US obligations. And one shared decision tree at the front. **3. Train decision-makers on both clock systems.** The person authorized to declare an incident reportable needs to know both the EU MDR day-count deadlines and the FDA MDR day-count deadlines. These are different numbers. Get them wrong and you are late. **4. Pre-draft your eMDR and FSCA templates.** In the middle of a real event, nobody has time to figure out what an eMDR form expects. Have the template ready, with example text, and rehearse filling it in during internal audits. **5. Map FDA recall classes to your internal CAPA severity levels.** This way, when FDA proposes a recall classification, your internal CAPA machinery already knows what that means in terms of urgency, escalation, and management review. **6. Reconcile FDA and EU field actions monthly.** If the same device has an open FDA correction and an open EU FSCA, the two records should tell the same story. Reconcile them monthly and close the gap if they diverge. **7. Get your US Agent involved early.** If you are an EU manufacturer without a US office, your US Agent is your interface for many FDA interactions. They must know they will be contacted during a real event, and they must have the authority to escalate to you in minutes, not days. ## Reality Check 1. Does our complaint intake form explicitly assess FDA MDR reportability and EU MDR reportability on every dual-market complaint, or do we rely on memory? 2. Who in our organization is authorized to declare an event reportable under 21 CFR 803, and do they know the clock starts at "awareness" not at "investigation complete"? 3. If FDA assigns Class I to a recall tomorrow, do we know what that triggers inside our company by end of day? 4. Have we mapped the FDA corrections and removals reporting thresholds against our EU FSCA triggers in a single document? 5. When was the last time we drafted a fake eMDR submission as a training exercise? 6. Does our US Agent have a current phone number and an escalation path that works at 3 a.m.? 7. Would an FDA inspector find one Post-Market Reporting SOP or two separate documents that contradict each other in the details? 8. Do we have a mechanism to reconcile the EU vigilance record and the FDA MDR record for each marketed device, and when did we last run it? ## Frequently Asked Questions **Is FDA MDR the same as EU MDR vigilance?** No. FDA MDR is 21 CFR Part 803. EU MDR vigilance is Articles 87-92 of Regulation (EU) 2017/745. The concepts overlap, the thresholds do not, and the reports go to different regulators. **Can I submit one report that satisfies both regulators?** No. Even if the underlying event is the same, FDA expects an eMDR submission, and the EU expects a serious incident report in the national competent authority system (transitioning to the EUDAMED vigilance module over time). Two separate submissions. **Who classifies a recall as Class I, II, or III?** FDA does. The manufacturer proposes and executes the corrective action; FDA assigns the class based on the health hazard evaluation. **What counts as "awareness" under FDA MDR?** Awareness is when any employee who would reasonably be expected to handle the information becomes aware. It is not when the quality team finishes investigating. Design your intake accordingly. **Do I need to report to FDA if the event happened in Germany on a device sold in the US market?** If the device is the same US-marketed device and the event meets 21 CFR 803 thresholds, yes. FDA does not care that the event physically happened outside the US. **What is the role of my US Agent in post-market events?** The US Agent handles communications between FDA and a foreign establishment. In a post-market event, they may receive FDA communications before you do. Make sure they have a working escalation path to your quality team. ## Related reading - [EU MDR Articles 87-92: vigilance framework](/blog/mdr-articles-87-92-vigilance-framework) – the EU-side baseline your dual-market process must also satisfy. - [Serious incidents under EU MDR](/blog/serious-incidents-mdr) – what triggers EU reporting, so you can compare against the FDA threshold. - [Recalls under EU MDR: withdrawing a device from market](/blog/recalls-mdr-withdrawing-device-from-market) – the EU counterpart to FDA corrections and removals. - [US Agent for FDA: the EU startup guide](/blog/us-agent-fda-eu-startups) – your interface for post-market communications with FDA. ## Sources 1. Regulation (EU) 2017/745 on medical devices, consolidated text. Articles 87, 88, and 89. 2. 21 CFR Part 803. Medical Device Reporting (FDA). 3. 21 CFR Part 806. Medical devices; reports of corrections and removals (FDA). 4. MDCG 2023-3 Rev.2 (January 2025). Vigilance terms and concepts Q&A. --- *This post is part of the [FDA & International Market Access](https://zechmeister-solutions.com/en/blog/category/fda-international) cluster in the [Subtract to Ship: MDR Blog](https://zechmeister-solutions.com/en/blog). For EU MDR certification consulting, see [zechmeister-solutions.com](https://zechmeister-solutions.com).*