Medical Device Reporting (MDR) Procedure | 21 CFR Part 803

Evaluate and document U.S. medical device adverse-event reporting decisions with this editable FDA Medical Device Reporting (MDR) Procedure. It covers 21 CFR Part 803 reportability evaluation, Form FDA 3500A, electronic MDR submission, acknowledgements, supplemental reports and records.

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Supplied as two editable Microsoft Word documents (the procedure and one form) in a digital download.

U.S. adverse-event reportability and submission records

The Medical Device Report (MDR) Procedure applies to all devices marketed in the United States unless excluded by FDA regulations. The Medical Device Report (MDR) Procedure provides instruction on submitting Med Watch Form 3500A, report processing, electronic eMDR Submission and the Electronic Systems Gateway (ESG).

• Evaluation of potentially reportable events

• Electronic MDR submission and receipt acknowledgement

• Supplemental reporting and record retention

For U.S. medical devices, the applicable quality-system framework is FDA's Quality Management System Regulation (QMSR), 21 CFR Part 820, effective February 2, 2026. It incorporates ISO 13485:2016 and includes additional FDA requirements. Adapt and implement this documentation for your device, activities and markets; purchasing a document does not establish regulatory compliance or certification.

Use this reporting process alongside the Complaint Handling Procedure for intake, investigation and complaint records.

When a reportable event also leads to a field action, see the Remedial Action and Recall Procedure. Both are included in the Complaint Handling Procedures Bundle.

Using an eQMS? These editable Microsoft Office files can be imported into any electronic quality management system (eQMS) that manages Word and Excel documents, or used in a paper-based system. Adapt the approval, signature and record steps to your system’s workflow, and validate the eQMS software under your own QMS. See how to use A.P. Lyon procedures in an eQMS.

Practical guide

Read FDA MDR, EU Vigilance and Medical Device Recall Workflows for workflow guidance, a checklist and common mistakes.

Part of a procedure bundle

This document is also included in Complaint Handling Procedures Bundle. Explore the bundle for the related documents.