1Is the complaint reportable? Decide in this order.
FDA uses MDR for a medical device report under 21 CFR Part 803; in Europe the letters name Regulation (EU) 2017/745, compared at the end with Great Britain and Canada. Evaluate every device-related complaint for reportability.¹²
| Step | Ask | If yes | If no |
|---|---|---|---|
| 1 | Did you make or import the device? | Step 2 | Forward the information to FDA with a cover letter (803.22(b)(2)).² |
| 2 | Did a device-related adverse event occur? | Step 3 | Not reportable; keep the documentation in the MDR files (803.22(b)(1)).² |
| 3 | Did a death or serious injury occur that the device may have caused or contributed to? | Step 5 | Step 4 |
| 4 | Did the device malfunction, and would that be likely to cause or contribute to a death or serious injury if it recurred? | Step 5 | Not reportable; record why (803.18(b)(1)(i)).² |
| 5 | Would a qualified person, such as a physician, nurse, risk manager or biomedical engineer, reasonably conclude that the device did not cause or contribute, or that the malfunction would not on recurrence? | Not reportable; keep the information that person used (803.20(c)(2)).² | Reportable: step 6 |
| 6 | Is remedial action needed to prevent an unreasonable risk of substantial harm, or has FDA asked for 5-day reports? | 5-day report (803.53).² | 30-day report (803.50).² |
Manufacturer includes specification developers, relabellers and US agents of foreign manufacturers (803.3(l)).² The calls that decide most files:
- Serious injury is life-threatening, causes permanent impairment or damage, or “necessitates medical or surgical intervention to preclude permanent impairment of a body function or permanent damage to a body structure” (803.3(w)).² A temporary threat to life still counts, and no malfunction is needed.¹
- Malfunction is a failure to meet performance specifications, which “include all claims made in the labeling”, or to perform as intended (803.3(k)).² “We presume that once the malfunction has occurred it will recur.”¹
- Once harm has happened, the presumption sticks. After a malfunction has caused or contributed to a death or serious injury, later events of the same malfunction stay reportable until two years pass with no further death or serious injury, or valid data show the risk is remote. FDA recommends notifying it with the data at two years; stopping sooner needs an exemption under 803.19.¹²
2The deadlines: 30-day, 5-day and supplemental.
| Report | Due | Clock starts the day after | Rule |
|---|---|---|---|
| 30-day report | 30 calendar days | Any employee becomes aware | 803.50(a)² |
| 5-day, remedial action | 5 work days | A manager or adverse-event reporter becomes aware the event needs remedial action | 803.53(a);² guidance 2.20¹ |
| 5-day, FDA request | 5 work days, for later events of the same nature in the period FDA sets | Any employee becomes aware | 803.53(b)² |
| Supplemental report | 30 calendar days | You receive the new information | 803.56² |
| Importers, user facilities | Importers 30 calendar days; user facilities 10 work days | Awareness | 803.40, 803.30² |
| Correction or removal | 10 working days, unless already reported under Part 803 | You initiate the correction or removal | 806.10(b) and (f)³ |
Awareness is the day any employee, in any role, has information that “reasonably suggests a reportable adverse event has occurred” (803.3(b)).²¹ The clock does not wait for the investigation: report what is “reasonably known”, explain any gap, and supplement later (803.50(b)).² FDA expects “at least one written (including email) request for information”.¹
A work day is Monday to Friday, except federal holidays (803.3(y)).² Part 803 counts calendar days for the 30-day clock and has no rule moving a deadline off a weekend, so a 30th day that falls on a Saturday is still the deadline.²
Remedial action is “any action other than routine maintenance or servicing” needed to prevent a reportable event recurring (803.3(v)).² Fixing only the device involved does not count. If FDA would consider the action a Class I recall, the MDR is due “within 5 work days of the decision to initiate the remedial action”.¹ Once the 5-day reports for the events that prompted the action are in, later events tied to it go back to 30-day reports, and an event already reported gets a supplemental report identifying the action.¹
A supplemental report, needed when new facts would alter what was filed, carries only the new, changed or corrected information and the original report number (803.56).²¹
For eligible product codes, FDA’s Voluntary Malfunction Summary Reporting Program allows most malfunction reports as quarterly summaries, though new types of malfunction and those tied to a 5-day report or a Part 806 correction still go individually.⁴⁵
A combination product approved under an NDA, ANDA or BLA owes five-day, malfunction and correction or removal reports for its device constituent part (4.102(c)(1)); see combination products under Part 4.⁶
3How to file: eMDR, Form 3500A and codes.
Manufacturers and importers must file initial and supplemental reports electronically (803.12(a)), a requirement in force since 14 August 2015.²⁷ A report carries the content of Form FDA 3500A, “if known or reasonably known”: patient (block A), event (B), device (D), initial reporter (E), reporting details (G) and manufacturer information (H) (803.52).² Investigators also check that reports carry the device’s UDI when it is known.⁸
- Low volume. Fill in the MedWatch 3500A form in FDA’s free eSubmitter tool and upload it through the ESG NextGen Unified Submission Portal. Test submissions are recommended, not required.⁷
- High volume. Generate the XML from your own system to FDA’s specification and send it by AS2 or API. Test submissions are required.⁷
- Codes. Block H needs evaluation codes (803.52(f)(6)).² FDA’s adverse event codes come in seven sets mapped to IMDRF annexes A to G: device problem, component, type of investigation, findings, conclusion, clinical signs and health impact. Choose the most specific code in each set; new codes now go through IMDRF, not FDA.⁹
- Two checks before sending. The report number is the site’s FDA registration number, the four-digit year of submission and a five-digit sequence number (803.3(m)), kept unchanged on supplements. Block H1, type of reportable event, must match the evaluation (803.52(f)(1)).² FDA cited Pensar Medical for a number with the wrong year and a serious injury filed as a malfunction.¹⁰
4Example: one complaint through every clock.
Example, invented. A US manufacturer makes Pump A, an infusion pump whose labelling claims an alarm whenever delivery stops.
| Date (2026) | What happened | Clock and due date |
|---|---|---|
| Monday 5 October | A field service engineer hears from a hospital nurse that a Pump A stopped infusing without alarming. Patient outcome unknown. | Awareness: an employee knows. 30-day report due Wednesday 4 November.² |
| Thursday 8 October | The complaint unit logs it. | No change: awareness stays 5 October.¹ |
| Tuesday 13 October | Failing to alarm breaks a labelled claim: a malfunction that could contribute to serious injury if it recurred, which is presumed. | Reportable malfunction.²¹ |
| Monday 2 November | 30-day malfunction report filed, saying the outcome is unknown and recording the emailed request to the hospital. | On time.²¹ |
| Monday 16 November | The hospital replies: the patient’s blood pressure infusion stopped, pressure fell and the patient was resuscitated. Life-threatening, so a serious injury. | Supplemental report changing the event type to serious injury, due Wednesday 16 December.²¹ |
| 10 to 19 November | Three more silent-stop complaints, on Tuesday 10, Thursday 12 and Thursday 19 November; no harm reported. | Each a 30-day report, due Thursday 10, Saturday 12 and Saturday 19 December: no extension under Part 803, where MDCG would move an EU deadline to Monday.²¹¹ |
| Monday 23 November | The quality director concludes from the four events that a firmware correction is needed to prevent an unreasonable risk of substantial harm. | 5-day reports for the three unfiled events, due Tuesday 1 December, as Thanksgiving on 26 November is not a work day. A supplemental report for the first event identifies the remedial action.²¹²¹ |
| Monday 30 November | The firmware correction starts in the field. | Part 806 report due Monday 14 December, unless already reported under Part 803.³ |
5The MDR procedure FDA tests.
Part 803 requires a written MDR procedure, and since 2 February 2026 FDA’s device inspection programme tells investigators: “Verify the firm follows their MDR procedures and they are effective in identifying MDR reportable deaths, serious injuries, and malfunctions.”²⁸ Under the QMSR, ISO 13485 clause 8.2.3, reporting to regulatory authorities, means notifying FDA of complaints that meet Part 803’s criteria (820.10(b)(3)), so quality system auditors look for the MDR procedure too.¹³ At Pensar Medical, FDA found that the procedure did not define what “reasonably suggests” a reportable event, and did not require documenting the deliberations behind each decision.¹⁰ Check yours:
| Procedure covers | What it should say | Rule |
|---|---|---|
| Intake | Every employee and channel forwards device events to the complaint unit at once; the first employee’s date is the awareness date | 803.17(a)(1);² guidance¹ |
| Definitions | Reasonably suggests, become aware, serious injury, malfunction, remedial action, work day | 803.17(a)(1);² Pensar¹⁰ |
| Decision | The steps above, who decides, who the qualified person is, and how fast | 803.17(a)(2);² 803.20(c)(2)² |
| Filing | Who files each report type by which clock; eMDR accounts and a back-up | 803.17(a)(3);² 803.12(a)² |
| Evaluation record | The information evaluated and the deliberations, for every event, reported or not | 803.17(b)(1);² 803.18(b)(1)(i)² |
| Access | Event files findable for follow-up and inspection, kept 2 years or the device’s expected life, whichever is longer | 803.17(b)(4);² 803.18(c)² |
6Not reportable? Write the rationale so it survives inspection.
The MDR event file must hold “all documentation of your deliberations and decision making processes used to determine if a device-related death, serious injury, or malfunction was or was not reportable” (803.18(b)(1)(i)).² Copy these fields into the complaint record:
| Field | What to write | Requirement |
|---|---|---|
| Complaint and device | Complaint number; device name, UDI and lot; date received; date any employee first knew; the event as reported, and its source | 803.3(b);² 820.35(a)¹³ |
| Death or serious injury | Yes, no or unknown, and why, against 803.3(w) | 803.50(a)(1)² |
| Malfunction | Yes or no; if yes, why recurrence would not be likely to cause or contribute to death or serious injury | 803.50(a)(2);² guidance 2.14¹ |
| Earlier harm | Has this malfunction ever caused or contributed to a death or serious injury? Report numbers | Guidance 2.15¹ |
| Evidence relied on | Investigation results, records and medical opinion, each referenced; the qualified person’s name and role | 803.20(c)(2)² |
| Missing information | What was requested, when and how; the replies | 803.50(b)(3);² guidance 2.23¹ |
| Decision | Not reportable, the reason in one sentence, date, approver | 803.17(a)(2)² |
| Reopen if | The facts that would change the answer | 803.56² |
7How FDA enforces it.
Investigators review a firm’s MAUDE reports before a device inspection.⁸
Absent additional information regarding the wound location, severity, or your firm’s rationale for determining that the event was not reportable, the available information reasonably suggests that the patient sustained an infection in the treated wound area that necessitated medical or surgical intervention, including removal of the retained foam, to preclude permanent impairment of a body function or permanent damage to a body structure.
Lion Street Medical, d/b/a Pensar Medical LLC, warning letter of 21 August 2026, on complaint C-029, a negative pressure wound therapy event filed as a malfunction.¹⁰
A serious injury MDR 2951238-2019-00404, submitted by your firm on February 1, 2019, documents a serious injury resulting from the same malfunction involving the same device.
Olympus Medical Systems Corporation, warning letter of 7 October 2026. Two February 2025 complaints of broken ceramic insulation on a resection set were reported three and seven months late, though the 2019 report made each reportable within 30 days.¹⁴
8FDA, EU MDR, Great Britain and Canada compared.
| Topic | FDA, 21 CFR 803 | EU MDR, Article 87 | Great Britain |
|---|---|---|---|
| What is reported | Deaths, serious injuries, and malfunctions likely to cause either if they recurred | Serious incidents, including those that “might have led or might lead” to death or serious deterioration, and field safety corrective actions | The same |
| Standard deadline | 30 calendar days | Immediately once a causal link is established or reasonably possible, and within 15 days | 15 days |
| Faster deadlines | 5 work days for remedial action or an FDA request | Immediately, and within 10 days for death or unanticipated serious deterioration, or 2 days for a serious public health threat | 10 days; 2 days |
| Unsure whether reportable | Not reportable only on a qualified person’s reasonable conclusion | Report within the deadline anyway | No express rule; report once a causal link is established or reasonably possible |
| After the first report | Supplemental report within 30 days of new information | Final report after the investigation (Article 89(5)) | Final report (regulation 44ZI) |
The EU counts calendar days from the day after awareness: the date the first employee or representative of the manufacturer, outsourced complaint handlers included, receives the information. A deadline ending on a Saturday, Sunday or public holiday moves to the next working day. Reports go on the Manufacturer Incident Report (MIR) form; where new information makes an incident first judged non-reportable reportable, the clock runs from the day after it arrives.¹¹
Health Canada wants a preliminary report within 10 days of awareness for a Canadian incident that led to death or a serious deterioration in health, or 30 days for one that could if it recurred, then a final report.¹⁷
9What changed in 2024 to 2026.
- 2 February 2026: the QMSR took effect, with complaint records under 820.35(a); FDA’s 2016 MDR guidance, which still cites the old 820.198, now opens with a note that it predates the QMSR.¹³¹
- 16 June 2025: Great Britain’s post-market surveillance regulations came into force.¹⁶
- January 2025: MDCG 2023-3 Rev.2, the current revision, covers the awareness date, calendar-day counting and the “Final (Non-reportable incident)” report type.¹¹
- Unchanged: Article 87’s deadlines, in the EU MDR consolidated to 9 November 2026, and the clocks in 803.50, 803.53 and 803.56, unamended since 14 February 2014.¹⁵²
For how the complaint itself is handled, see complaint handling; for the CAPA a reportable trend usually opens, see what CAPA is.
10How it runs in Seal.
In Seal’s complaint handling workflow, a reportability assessment keeps the criteria applied, the facts known at the time, what is still missing and the reviewer’s rationale; when new facts arrive it is revised, and the earlier decision stays in its history. Seal keeps each receipt and awareness event with its source, so the qualified reviewer can see when the organisation could have known, not only when the complaint unit logged the report. A regulatory report carries its deadline basis, dispatch, acknowledgement, follow-up and amendments, linked to the assessment that required it.
For regulatory obligations, awareness date, statutory due date and internal target are separate fields, and date calculations retain the rule and calendar used. Neil can compare recurring complaints across lots and distribution exposure; complaint and quality owners assess significance and the reporting obligations that apply. For device makers, the medical device blueprint prepares serious incident reporting and FSCA documentation from the complaint trend, affected lots and distribution records, with notification tracking.
References
- 1Medical Device Reporting for Manufacturers, guidance for industry and FDA staff, sections 2.20 to 2.22, FDA, 8 November 2016, with its QMSR note. https:/
/ www. fda. gov/ media/ 86420/ download (read 8 November 2026) - 221 CFR Part 803, Medical Device Reporting, sections 803.3, 803.12, 803.17, 803.18, 803.19, 803.20, 803.22, 803.30, 803.33, 803.40, 803.50, 803.52, 803.53 and 803.56, eCFR, current to 5 November 2026. https:/
/ www. ecfr. gov/ current/ title- 21/ chapter- I/ subchapter- H/ part- 803 (read 8 November 2026) - 321 CFR 806.10, Reports of corrections and removals, eCFR. https:/
/ www. ecfr. gov/ current/ title- 21/ section- 806. 10 (read 8 November 2026) - 4Medical Devices and Device-Led Combination Products; Voluntary Malfunction Summary Reporting Program, notice, 83 FR 40973, FDA, 17 August 2018. https:/
/ www. federalregister. gov/ documents/ 2018/ 08/ 17/ 2018- 17770/ medical- devices- and- device- led- combination- products- voluntary- malfunction- summary- reporting- program (read 8 November 2026) - 5Mandatory Reporting Requirements: Manufacturers, Importers and Device User Facilities, FDA. https:/
/ www. fda. gov/ medical- devices/ postmarket- requirements- devices/ mandatory- reporting- requirements- manufacturers- importers- and- device- user- facilities (read 8 November 2026) - 621 CFR Part 4, Regulation of Combination Products, section 4.102, eCFR. https:/
/ www. ecfr. gov/ current/ title- 21/ chapter- I/ subchapter- A/ part- 4 (read 8 November 2026) - 7How to Enroll in eMDR Program, FDA, updated 13 April 2026. https:/
/ www. fda. gov/ medical- devices/ emdr- electronic- medical- device- reporting/ how- enroll- emdr- program (read 8 November 2026) - 8Compliance Program 7382.850, Inspection of Medical Device Manufacturers, Medical Device Reporting, FDA, issued and implemented 2 February 2026. https:/
/ www. fda. gov/ media/ 80195/ download (read 8 November 2026) - 9MDR Adverse Event Codes, FDA, content current as of 21 August 2026. https:/
/ www. fda. gov/ medical- devices/ mandatory- reporting- requirements- manufacturers- importers- and- device- user- facilities/ mdr- adverse- event- codes (read 8 November 2026) - 10Warning letter to Lion Street Medical, d/b/a Pensar Medical LLC, MARCS-CMS 733015, FDA, 21 August 2026. https:/
/ www. fda. gov/ inspections- compliance- enforcement- and- criminal- investigations/ warning- letters/ lion- street- medical- dba- pensar- medical- llc- 733015- 08212026 (read 8 November 2026) - 11MDCG 2023-3 Rev.2, Questions and Answers on vigilance terms and concepts, questions 12, 14, 15 and 16, Medical Device Coordination Group, January 2025. https:/
/ health. ec. europa. eu/ document/ download/ af1433fd- ed64- 4c53- abc7- 612a7f16f976_ en?filename=mdcg_ 2023- 3_ en. pdf (read 8 November 2026) - 125 U.S.C. 6103, Holidays, United States Code, govinfo. https:/
/ www. govinfo. gov/ content/ pkg/ USCODE- 2023- title5/ html/ USCODE- 2023- title5- partIII- subpartE- chap61- subchapI- sec6103. htm (read 8 November 2026) - 1321 CFR Part 820, Quality Management System Regulation, sections 820.7, 820.10(b) and 820.35(a), eCFR, current to 5 November 2026. https:/
/ www. ecfr. gov/ current/ title- 21/ chapter- I/ subchapter- H/ part- 820 (read 8 November 2026) - 14Warning letter to Olympus Medical Systems Corporation, MARCS-CMS 729208, FDA, 7 October 2026. https:/
/ www. fda. gov/ inspections- compliance- enforcement- and- criminal- investigations/ warning- letters/ olympus- medical- systems- corporation- 729208- 10072026 (read 8 November 2026) - 15Regulation (EU) 2017/745 on medical devices, Articles 2(64) to 2(66), 87 and 89, consolidated version of 9 November 2026, EUR-Lex. https:/
/ eur- lex. europa. eu/ legal- content/ EN/ TXT/ HTML/ ?uri=CELEX:02017R0745- 20261109 (read 8 November 2026) - 16The Medical Devices (Post-market Surveillance Requirements) (Amendment) (Great Britain) Regulations 2024, SI 2024/1368, regulations 44ZH, 44ZI and 44ZJ, legislation.gov.uk, made 16 December 2024. https:/
/ www. legislation. gov. uk/ uksi/ 2024/ 1368/ made (read 8 November 2026) - 17Medical Devices Regulations, SOR/98-282, sections 59 to 61, Justice Laws Website, Government of Canada, current to 19 October 2026. https:/
/ laws- lois. justice. gc. ca/ eng/ regulations/ sor- 98- 282/ FullText. html (read 8 November 2026)
AQuestions and answers
What counts as a serious incident under the EU MDR?
An incident that directly or indirectly led, might have led or might lead to a death, a temporary or permanent serious deterioration in someone’s health, or a serious public health threat. MDCG lists a life-threatening illness or injury, impairment of a body structure or function, hospitalisation, and medical or surgical intervention to prevent these among the deteriorations that can count. An incident with no harm is still serious unless the manufacturer can exclude that, in less favourable circumstances, it could have led to one of these outcomes.
When is a trend report needed under the EU MDR?
When there is a statistically significant increase in the frequency or severity of incidents that are not serious incidents, or of expected undesirable side-effects, that could significantly affect the benefit-risk analysis. The method for detecting the increase and the observation period belong in the post-market surveillance plan.
Is a use error MDR reportable?
It can be. FDA counts user error among the ways a device can cause or contribute to a death or serious injury, and wants those events reported, because they often reflect labelling or design problems. An event caused solely by user error, with no other performance issue and no death or serious injury, need not be reported, but the supporting information stays in the complaint file.
Does a contract manufacturer have to submit MDRs?
Not if it does not market or distribute the devices it makes for the specification developer. If both firms market the device, both have reporting duties, and they can jointly ask FDA for an exemption so that only one files.
Does each device need its own MDR when several were involved?
Yes, for a manufacturer. FDA asks for a separate report for each of your devices that may have contributed to the event when you cannot tell which one did. A user facility may send one report covering several suspect devices.