Medical Device Reporting and Complaint Handling Program

A medical device reporting (MDR) program organizes role-specific reporting procedures, event files and deadlines under 21 CFR Part 803. Integral Healthcare Solutions (IHS) drafts these materials for manufacturers, importers and hospital user facilities, together with complaint intake and review workflows. Your organization and regulatory counsel determine applicability and reportability.

Last updated: November 2026

What does 21 CFR Part 803 require of manufacturers, importers and user facilities?

Part 803 assigns duties by role. User facilities report device-related deaths and serious injuries; manufacturers and importers also report qualifying malfunctions. Distributors retain incident records. Under section 803.33, user facilities submit annual reports to the Food and Drug Administration (FDA) by January 1, unless they submitted no MDRs to manufacturers or FDA during the reporting period.

The governing text is 21 CFR Part 803, Medical Device Reporting, current eCFR, page opened November 5, 2026. Under section 803.3(o), user-facility reportability concerns information reasonably suggesting device involvement in death or serious injury. For manufacturers and importers, it also includes malfunctions likely to cause or contribute to death or serious injury if they recur in the device or a similar marketed device. Section 803.3 defines serious injury and role-specific awareness; section 803.19 provides exemptions and reporting modifications.

Under section 803.53(b), a written five-day request also covers subsequent events of the same nature involving substantially similar devices during the specified period, without further requests; FDA may extend that period in the public-health interest. The table’s deliverables are IHS’s proposed implementation tools.

Who needs it and what triggers it?

Manufacturers, importers and user facilities have written-procedure and event-file duties under sections 803.17–803.18; distributors have incident-record duties. Applicability and any section 803.19 reporting modification need review. IHS offers drafting support when:

• An organization lacks a tracker for the reportable events and deadlines applicable to its role.
• A hospital user facility is building its adverse event reporting workflow and its annual report.

How IHS helps

IHS runs a gap assessment of your current procedures against sections 803.17 and 803.18 and the deadlines in section 803.10, maps the evidence you hold, and drafts what is missing. Deliverables include a decision tree, review procedure, event and complaint forms, timeline tracker, retention index and training. IHS runs a mock review and supports readiness; the client approves all drafts, including clinician approval of clinical content. Integral Healthcare Solutions (IHS) was founded in 2002 by Thomas G. Goddard, JD, PhD, former Chief Operating Officer and General Counsel of URAC, and works across three practice lines: accreditation consulting, compliance services and program development. This build sits in our Compliance Services practice line.

Your organization supplies its role under Part 803 and the devices involved, the event information, medical record references and engineering reports, and the regulatory counsel who confirms obligations. The client makes any electronic submission to FDA.

The limit: IHS does not submit reports to FDA and does not communicate with FDA for you. IHS does not decide whether a given event is reportable, because you and your regulatory counsel do. For manufacturers, 21 CFR 820.35(a), current QMSR (page opened November 5, 2026), requires complaint review, evaluation and investigation records for possible device, labeling or packaging specification failures. A similar complaint already investigated need not be reinvestigated if the justification is recorded. For MDR-reportable complaints, complaints determined to need investigation, and complaints investigated anyway, records include device identification, receipt date, complainant details, complaint details, corrections or corrective action, and replies. IHS drafts the workflow and record fields; the client performs and approves evaluations.

What to have ready

Bring these materials for review against 21 CFR Part 803, current eCFR (page opened November 5, 2026):

1. Your role and device list, for the definitions in 803.3.
2. Written procedures, for 803.17.
3. Your reportability review process, for 803.17(a)(2).
4. Event files and retention schedules, for 803.18.
5. Awareness dates, for 803.10 deadline testing.
6. Annual-report records or the basis for the no-report exception, for 803.33.

If several are missing, book the free introductory call.

How does outside drafting support compare with other routes?

The routes include an internal quality or risk team, regulatory counsel, regulatory affairs software, and outside drafting support. Compare who will draft procedures, review legal obligations, maintain records and submit reports; software capabilities need evaluation for your workflow. IHS supplies drafts for client adoption. Device establishment registration and listing is a separate service described on our registration and listing page.

What does it cost?

FDA does not publish a fee schedule on the pages we reviewed; fees depend on scope. IHS scopes each engagement after a free introductory call. Engagement scope depends on your roles, device lines and gaps in procedures and records.

Your own staff time is the third cost. Your quality, risk and regulatory staff supply event information, review drafts and make the reportability decisions with counsel, and that time is yours whichever route you take.

What this is not

This is not legal advice. IHS is a consulting firm, not a law firm, and your regulatory counsel confirms your obligations. It is not a decision on whether any event is reportable, and it is not a guarantee of any inspection result. IHS does not submit anything to FDA; you do.

Frequently asked questions

What does 21 CFR Part 803 require of manufacturers, importers and user facilities?

Manufacturers and importers report device-related deaths, serious injuries and qualifying malfunctions; manufacturers also submit required followup information. User facilities report device-related deaths and serious injuries and submit annual reports unless section 803.33(d) applies. Sections 803.17–803.18 require written MDR procedures and event files for these roles.

What are the MDR reporting deadlines for each role?

User-facility reports are due within 10 work days after the day of awareness; deaths must also be reported as soon as practicable (803.30). Importers report as soon as practicable and within 30 calendar days after the day of awareness (803.40). Manufacturers report within 30 calendar days after the day of awareness of a reportable death, serious injury or malfunction (803.10(c)(1)). The manufacturer deadline is 5 work days after the day of awareness of a reportable event requiring remedial action to prevent an unreasonable risk of substantial harm to public health, or an applicable FDA written request; that request also covers subsequent same-nature events involving substantially similar devices during its specified period (803.53).

What does a hospital user facility have to do?

A hospital user facility reports device-related deaths and serious injuries and maintains event files. Its annual report is due to FDA by January 1 unless it submitted no MDRs to manufacturers or FDA during the reporting period (section 803.33). IHS drafts the workflow, file template and calendar; your organization and counsel decide reportability.

What must written MDR procedures contain?

For user facilities, importers and manufacturers, section 803.17 requires written procedures covering event identification, communication and evaluation; consistent reportability review; and timely transmission of complete reports to the required recipients. Records cover evaluated information, submitted reports, annual-report preparation and access for timely followup and FDA inspection.

What goes in an MDR event file?

Under section 803.18(b), files contain event information or references, documented decisions on whether to report, copies of reports and other submitted event information, and FDA electronic acknowledgments. For manufacturers, section 803.18(e) also requires evaluation results and explanations for missing required information; FDA will not consider the MDR compliant unless the event is evaluated under Part 820’s quality-management requirements.

Is a distributor required to report adverse events?

A distributor as defined in section 803.3(e), excluding manufacturers and importers, keeps incident records but need not report incidents under section 803.1(a). Repackaging or relabeling can make it a manufacturer. Section 803.18(d) requires incident information and any evaluation, device-name filing, electronic backups, and retention for 2 years from inclusion in the file or the device’s expected life, whichever is greater, even after distribution ends.

Does Part 803 replace the quality system rules in Part 820?

No. Section 803.1(b) supplements Part 820; section 820.10(b)(3) requires manufacturers subject to Part 820 to notify FDA of complaints meeting Part 803 reporting criteria. IHS drafts linked complaint and MDR records for client review; this engagement is not a complete QMSR implementation.

Who decides whether an event is reportable?

You and your regulatory counsel decide. IHS does not make that call and does not communicate with FDA for you. IHS drafts the decision tree and the files that record how each decision was made.

What does an MDR program build cost?

The regulatory pages reviewed here do not publish an MDR-program fee schedule. IHS scopes each engagement after a free introductory call based on your roles, device lines and existing procedures and records. Include your own quality and regulatory staff time in planning.