Adverse Event Reporting Services & Solutions

For medical devices, FDA adverse event reporting is primarily governed by 21 CFR Part 803. Manufacturers must evaluate complaints, deaths, serious injuries, and certain malfunctions to determine reportability, submit Medical Device Reports within required timelines, maintain event files, and document the rationale for reportable and non-reportable decisions. Complaint handling under 21 CFR Part 820 also needs to align with these reporting obligations.

The four minimum criteria generally include an identifiable patient, an identifiable reporter, a suspect device or product, and an adverse event or outcome that can be reasonably described. If those core elements are present, the case usually requires formal evaluation for reportability. Manufacturers should also document missing details, follow up for additional information, and preserve a clear assessment trail.

Reporting timelines depend on the jurisdiction and event type. Under FDA MDR rules, certain events must be reported within 30 calendar days, while some situations may require 5-day reporting. EU and other global frameworks also impose strict vigilance deadlines based on seriousness and public health risk. A reliable intake and triage process is essential to avoid missed deadlines.

A complaint is any written, electronic, or oral communication alleging deficiencies related to identity, quality, durability, reliability, safety, effectiveness, or performance. An adverse event is a subset of complaints involving death, serious injury, malfunction, or other reportable safety concerns. Not every complaint is reportable, but every complaint should be assessed to determine whether adverse event reporting obligations apply.

Yes, in many cases they do. Under FDA MDR requirements, a malfunction may be reportable if it would be likely to cause or contribute to a death or serious injury if it recurred. That means manufacturers must assess not only actual harm, but also the potential severity of a repeat event. Clear malfunction definitions and documented decision logic are critical.

A defensible decision file should include the original complaint record, event description, device identification, investigation findings, seriousness assessment, reportability rationale, applicable regulatory references, submission dates if reported, and follow-up actions. It should also show how the event connects to CAPA, risk management, and PMS where relevant. Regulators expect consistency, traceability, and timely closure across the full record.

Yes. Elexes supports manufacturers working across FDA, EU MDR, IVDR, TGA, Health Canada, and other international frameworks. That includes reportability assessments, vigilance submissions, complaint governance, PMS integration, and authority response support. This is especially valuable for companies managing the same product family across multiple markets with different reporting thresholds and timelines.

Outsourced RAQA support gives manufacturers access to experienced regulatory and quality professionals without building a full in-house team. An embedded partner can review incoming complaints, assess reportability, prepare submissions, maintain documentation, and connect events to PMS and CAPA workflows. This improves consistency, reduces internal bottlenecks, and helps organizations stay compliant during growth, audits, or resource gaps.