FDA Medical Device Reporting for UK Manufacturers: 5-Day and 30-Day Deadlines Explained

A manufacturer of a device marketed in the US must submit a Medical Device Report to FDA within 30 calendar days of becoming aware of a reportable death, serious injury or malfunction, and within 5 work days where the event calls for remedial action to prevent an unreasonable risk of substantial harm to the public health. A UK manufacturer is not exempt, and FDA's guidance treats some events occurring abroad as reportable too. This guide is based on 21 CFR Part 803 and FDA's MDR guidance, indexed in our FDA surgical robotics and SaMD base. It does not cover MHRA vigilance, UKCA or CE-marking obligations, which the base does not contain.

Who counts as a “manufacturer” under Part 803

Part 803 defines a manufacturer broadly (803.3(l)). The definition covers anyone who manufactures, assembles or processes a device, but also anyone who initiates specifications for devices made by a second party, anyone who relabels, and the US agent of a foreign manufacturer. Section 803.58, which sets out duties for foreign manufacturers' US designated agents, carries an eCFR note that it was stayed indefinitely in 2014. Do not build your process on that section without checking its current status with FDA.

If your devices reach the US through an importer, the importer has its own duties: deaths and serious injuries go to FDA with a copy to you, and malfunctions go to you (803.40, as summarised in FDA's guidance). FDA's guidance also explains that a foreign manufacturer and its importer can ask FDA for an exemption under 803.19(b) so that the importer files on both firms' behalf. FDA recommends a joint request specifying which reports the importer will submit.

The deadlines at a glance

Events that happen in the UK can be reportable

This is the point UK teams most often miss. FDA's MDR guidance (section 4.11.3) answers yes to the question of whether a foreign manufacturer must report an event occurring in a foreign country. FDA considers such an event reportable if it involves a device cleared or approved in the US, or a similar device, that is also lawfully marketed in the foreign country. The guidance adds that devices made to slightly modified specifications for other countries are covered if the changes do not substantially alter performance.

The guidance draws a contrast with devices that are not cleared or approved in the US and are only being studied under an IDE. Events with those devices abroad are generally not MDR-reportable. However, a malfunction abroad should be reported if a similar device you market in the US would be likely to cause or contribute to death or serious injury if it recurred.

• Feed UK and other non-US complaints into the same reportability screen as US complaints.
• Map which UK product variants are “similar devices” to your US-cleared models.
• Submit every report in English (803.13) and in an electronic format FDA can process (803.12(a)), unless FDA has granted an exemption.

Starting the clock: “become aware” and remedial action

For 30-day reports, a manufacturer becomes aware when any employee learns of a reportable event (803.3(b)(2)). For remedial-action 5-day reports, the trigger is narrower. It is the moment a person with management or supervisory responsibility over regulatory, scientific or technical staff, or whose job involves adverse-event reporting, realises from any information, trend analysis included, that remedial action is needed. FDA's guidance counts the 5-day window from the following day.

Remedial action means any action other than routine maintenance or servicing that is necessary to prevent a reportable event from recurring (803.3(v)). Per FDA's guidance, fixing only the single device involved is not remedial action. Only remedial actions addressing an unreasonable risk of substantial harm make the event a 5-day report; the others are filed as 30-day reports. If the action is one FDA would treat as a Class I recall, the report is due within 5 work days of the decision to act.

Records, procedures and the quality system link

Section 803.17 requires written MDR procedures for timely identification and evaluation of events, a standardised reportability review and timely submission. FDA's guidance adds that those procedures should identify the roles of contractors or consultants who review complaints on your behalf, which is relevant if a US partner screens complaints for you. Section 803.18 requires MDR event files documenting your reportability decisions, kept for 2 years from the event or the device's expected life, whichever is longer.

The quality system rule points the same way. The QMSR in 21 CFR Part 820 applies to finished devices imported or offered for import into the US (820.1). Section 820.10(b)(3) requires manufacturers to notify FDA of complaints meeting the Part 803 criteria. FDA's notice on the MDR guidance confirms that the QMSR, incorporating ISO 13485:2016 by reference, took effect on 2 February 2026, so older references in the 2016 guidance to the former Quality System regulation should be read in that light.

Two definitions shape most decisions. A serious injury is one that is life-threatening, causes permanent impairment or damage, or needs medical or surgical intervention to prevent it (803.3(w)). Caused or contributed expressly includes user error (803.3(c)). FDA's guidance says that 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 belongs in your complaint files. For robotic systems, FDA's computer-assisted surgery page notes that most reports it receives describe malfunctions such as component breakage, mechanical problems and image or display issues.

Checklist for a UK manufacturer with US-cleared devices

1. Confirm who files: you directly, or your importer under an 803.19(b) exemption.
2. Log the “become aware” date for each complaint, in whichever country it arises, and separately log when a supervisor saw signs that remedial action was needed.
3. Apply the malfunction test without debating recurrence: FDA presumes a malfunction will recur.
4. Run a US work-day calendar (US Federal holidays only) alongside your UK calendar.
5. Diary 30-calendar-day supplemental deadlines as new information arrives.
6. Keep MDR event files that record why each event was or was not reported.

For specific edge cases, ask the base, for example: “Must an adverse event in a foreign country be reported under MDR if the device is cleared in the US?” You will get the relevant section of the guidance quoted back.

Sources: 21 CFR Part 803 (eCFR) and FDA, Medical Device Reporting for Manufacturers. This is an explanation of the rules, not advice on a particular event.