When is a report required?

A post-market surveillance report is required when FDA issues a Section 522 order or when internal quality processes and regulatory guidance indicate systematic review is necessary. Manufacturers also prepare periodic reports to support CAPA and device safety monitoring.

Can the report be signed electronically?

Yes. Electronic signatures are legally valid under ESIGN (15 U.S.C. §7001) and UETA where applicable, provided intent, consent, attribution, and retention requirements are met. For FDA-regulated records, ensure Part 11 controls are satisfied.

How quickly must adverse events be reported?

Individual MDRs for deaths and serious injuries generally must be submitted within 30 calendar days under FDA MDR regulations; follow 21 CFR Part 803 for specific timelines and reporting conditions.

What audit evidence should accompany the report?

Provide source data extracts, complaint narratives, analytical methods, CAPA cross-references, and an unalterable audit trail showing reviewer actions and signatures to support inspection readiness.

Who is authorized to sign the report?

An authorized company official designated by internal delegation of authority should sign. Signatory must be able to attest to data accuracy and regulatory conformity; document the authorization.

How should records be stored long-term?

Retain the report and underlying records per retention policy: maintain active records while marketed and retain post-termination per applicable federal and state rules (HIPAA six years, IRS three years baseline) and your internal records schedule.

Electronic Signature
Templates
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Post-Market Surveillance Report

Post-Market Surveillance Report

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POST-MARKET SURVEILLANCE REPORT AND SERVICE AGREEMENT

Parties and Report Identifiers

Manufacturer / Sponsor Name Manufacturer Address Report Number / Reference Device / Product Name and Model

Surveillance Period: From to . Report prepared by , Title: .

Recitals

WHEREAS, Manufacturer engages Service Provider to perform post-market surveillance activities for the device identified above to monitor safety, performance and compliance with regulatory obligations; and

WHEREAS, Service Provider has the technical expertise, data access and systems necessary to collect, analyse and report adverse events, complaints, device failures, and real-world performance data and will deliver a written Post-Market Surveillance Report in accordance with the terms set forth herein; and

WHEREAS, the parties intend that this Report and Service Agreement memorialize the scope, deliverables, fees and legal commitments associated with the surveillance activities and acceptance of the Report.

Scope of Work

Description of Surveillance Activities Methodology and Data Sources

Findings, Analysis and Actions

Executive Summary of Findings Adverse Events and Complaints (Narrative)

Total units reviewed: & Reported adverse events (total): & Serious adverse events: .

Corrective and Preventive Actions (CAPA)

Payment Terms

Total Fee: . Payment schedule: Deposit of due on engagement; balance due within days of final Report delivery.

Late payment shall incur a late fee equal to per month on any overdue balance, and the Service Provider may suspend delivery of non-time-critical follow-up activities until amounts due are paid.

Term and Termination

This Agreement commences on and continues through unless earlier terminated as provided below.

Either party may terminate for convenience upon written notice delivered not less than days prior to termination. Termination for cause may be effected immediately upon written notice if the other party materially breaches a material obligation and fails to cure within 15 days after notice of breach.

Confidentiality

Each party shall maintain as confidential all non-public information disclosed in connection with this surveillance engagement, including but not limited to adverse event narratives, complaint details, proprietary analysis, and identifiable patient data. Confidential information shall not be used except to perform obligations under this Agreement and shall not be disclosed to third parties without the disclosing party's prior written consent, except where disclosure is required by applicable law or regulation, in which case the disclosing party shall provide prompt notice to the other, to the extent permitted.

Confidentiality Acknowledgement

I acknowledge that I have read and accept the confidentiality obligations set forth above.

Governing Law; Entire Agreement

This Agreement shall be governed by and construed in accordance with the laws of the jurisdiction of the Manufacturer's principal place of business, without regard to conflict of law principles. Any dispute arising out of or relating to this Agreement shall be resolved by the courts of that jurisdiction.

This document, together with any referenced appendices and the delivered Post-Market Surveillance Report, constitutes the entire agreement between the parties with respect to the subject matter hereof and supersedes all prior proposals, negotiations and agreements, whether written or oral. No amendment or waiver shall be effective unless in writing and signed by authorized representatives of both parties.

Acceptance and Certifications

Report Conclusions and Recommended Regulatory Notifications Reviewer Name Reviewer Title and Organization

The undersigned certify on behalf of their respective organizations that the information set forth in this Post-Market Surveillance Report is true and accurate to the best of their knowledge and that the Agreement terms have been accepted.

Manufacturer:

By:

Date:

Service Provider:

By:

Date:

What the Post-Market Surveillance Report Is and when it applies

A Post-Market Surveillance Report documents safety, performance, and real-world experience for a marketed medical device after it reaches U.S. distribution. It aggregates adverse events, trends, corrective actions, and risk-mitigation measures collected through complaint handling, automatic monitoring, registries, and user feedback. Manufacturers use the report to satisfy FDA postmarket obligations (including Section 522 orders where applicable), inform periodic quality reviews, and support regulatory submissions such as corrective and preventive action records and 510(k)/PMA follow-ups. The report is distinct from individual Medical Device Reports (MDRs) and focuses on aggregated evidence, analysis, and recommended next steps.

Why compiling a clear Post-Market Surveillance Report matters

A structured report helps detect safety trends, reduce patient risk, and demonstrate regulatory control over marketed devices. It strengthens audit readiness and supports data-driven decisions for corrective actions and labeling updates.

Primary users and contributors for this report

The Post-Market Surveillance Report is prepared by cross-functional teams that collect clinical, quality, and field data before final assembly into the report.

Regulatory Affairs — Consolidates regulatory obligations, reporting timelines, and submission-ready material.
Quality Assurance — Validates data sources, trend analyses, CAPA linkage, and document control.
Clinical Affairs / Safety — Interprets clinical and postmarket data, risk assessments, and clinical follow-up plans.

External stakeholders such as notified bodies, the FDA, and clinical investigators may review the report depending on statutory requirements and follow-up actions.

Essential sections every professional report should include

A complete Post-Market Surveillance Report combines source data, analysis, and traceability to quality systems so reviewers can evaluate safety and compliance at a glance.

Executive Summary

Concise overview of key findings, safety signals, and recommended actions with high-level metrics and next steps for management and regulators.

Device and Scope

Device identifiers, model numbers, intended use, distribution regions, and the surveillance period covered by the report to set context and applicability.

Data Sources

List of inputs (complaint logs, MDRs, registries, literature, postmarket studies), data collection dates, and data quality notes for traceability.

Analysis & Trends

Quantitative analyses, adverse event trend lines, root-cause hypotheses, and statistical comparisons versus baseline expectations.

Corrective Actions

Linkage to CAPA records, field safety corrective actions, label changes, and timelines for closure or further study.

Regulatory Conclusion

Risk assessment summary, regulatory impact (e.g., 522 study recommendation), and whether additional reporting or study is advised.

Required data elements and minimum metadata

Device ID: UDI or model number

Manufacturer: Legal name and contact

Surveillance Period: Start and end dates

Data Sources: Source type and volume

Event Counts: Aggregate case totals

CAPA Links: Reference numbers

Step-by-step: assembling a Post-Market Surveillance Report

Follow this sequence to collect, validate, analyze, and sign off on the surveillance report in a compliant manner.

01

Collect Data: Gather MDRs, complaints, registries, literature, and study results.
02

Validate Sources: Confirm completeness, date ranges, and data quality before analysis.
03

Analyze Trends: Run incidence calculations and compare against expected baselines.
04

Document Findings: Draft conclusions, CAPA links, and signatory statements for finalization.

Where to send or file the completed report

Federal submission paths vary by purpose: routine internal reports differ from regulatory responses or Section 522 studies. Use the route that matches your obligation.

Internal Quality System: File in QMS for CAPA and audit readiness.
FDA Submission: Submit to FDA when required by 21 CFR Part 803 or a Section 522 order.
Notified Bodies / International: Share with EU or other regulators per applicable requirements.
Clinical Partners: Provide reports to study sponsors or registry administrators as needed.

Electronic submission and signature considerations

Electronic delivery must support audit trails, secure storage, and authorized signatory authentication for regulatory acceptance.

Audit Trail: Capture timestamp, IP, and signer identity
Authentication: Use MFA, SMS, or KBA as required
Record Integrity: Ensure tamper-evident storage and version control

Choose a platform that meets FDA electronic record guidance (21 CFR Part 11) and federal e-signature acceptance (ESIGN and UETA) while preserving secure long-term access.

Typical eSubmission workflow settings

Configure a controlled workflow so data capture, reviewer approvals, and final signatures are auditable and reproducible.

Field	Configuration
Authentication	Email + SMS code \| MFA recommended
Role-Based Routing	Sequential approvals by QA, RA, Clinical
Audit Trail Retention	Retain logs per policy
Document Versioning	Lock prior versions on signature

Regulatory and operational risks of incorrect reporting

MDR Noncompliance: Regulatory enforcement actions

Incomplete Data: Delayed corrective action

Misattributed Events: Incorrect root-cause conclusions

Late Submissions: Civil penalties possible

Poor Traceability: Audit findings and remediation

Retention Failures: Legal exposure

Common mistakes teams make preparing this report

Relying on incomplete complaint data without reconciling duplicate entries leads to inflated counts and misdirected CAPA efforts.
Using inconsistent denominators (shipments vs patient exposures) when calculating incidence rates creates misleading trend comparisons.
Failing to link CAPA records and closure evidence means corrective actions are not demonstrably tied to the surveillance findings.
Not preserving raw source files and audit trails can trigger inspection citations and extend remediation timelines.

Key timelines tied to FDA reporting obligations

Adhere to the FDA timeframes for individual and aggregate reporting; aggregated surveillance reports follow project-specific schedules or Section 522 orders.

MDR Reporting Deadline:

Manufacturers must report deaths and serious injuries within 30 days (21 CFR Part 803)

New Safety Signal:

Investigate and document rapidly; interim notifications may be required

Section 522 Studies:

Follow study-specific milestones per FDA order

CAPA Closure:

Document evidence and timelines for regulatory review

Periodic Surveillance:

Schedule annual or study-based reporting as required

Practical steps to improve accuracy and efficiency

Adopt reproducible workflows and clear responsibilities to reduce rework and support inspections.

Standardized Templates

Use a controlled template that enforces required fields and links directly to CAPA and complaint records to minimize omissions.

Single Source of Truth

Manage raw data in a controlled repository to avoid inconsistent analyses and support traceability during audits.

Role-Based Reviews

Assign distinct reviewer roles (QA, RA, Clinical) with documented sign-off to create a clear audit trail and accountability.

Electronic Audit Trails

Capture signer identity, timestamp, and version history to meet 21 CFR Part 11 and ESIGN expectations for electronic records.

Real-world examples of how reports are used

Two illustrative scenarios show typical outcomes and how surveillance shaped corrective steps.

Hospital Safety Review

A health system aggregated device complaints across sites for six months

Analysis showed a spike in a connector failure
The manufacturer issued a label update and tracked field actions, reducing incident rate within two quarters.

Manufacturer CAPA Decision

A manufacturer noticed increased MDR reports following a software update

Root-cause analysis linked the update to usage changes
They rolled back the update, issued an advisory, and opened a controlled study to validate the fix.

Common eSignature vendors and per-user pricing for form signing

Trusted eSignature providers differ by pricing model, platform limits, and compliance support; signNow is shown first for direct comparison.

	signNow	DocuSign	Adobe Sign	PandaDoc	HelloSign
Starting Price	$8/user/mo	$15/user/mo	$14/user/mo	$19/user/mo	$15/user/mo
Free Trial	7-day free trial	Yes	Yes	Yes	Yes
Bulk Send	Yes	Yes	Yes	Yes	No
Audit Trail	Yes	Yes	Yes	Yes	Yes
HIPAA Compliant	Yes	Yes	Yes	No	No

Frequently asked questions about Post-Market Surveillance Reports

Answers to common procedural and compliance questions encountered when preparing or submitting these reports.

Need help? Contact support

When is a report required?
A post-market surveillance report is required when FDA issues a Section 522 order or when internal quality processes and regulatory guidance indicate systematic review is necessary. Manufacturers also prepare periodic reports to support CAPA and device safety monitoring.
Can the report be signed electronically?
Yes. Electronic signatures are legally valid under ESIGN (15 U.S.C. §7001) and UETA where applicable, provided intent, consent, attribution, and retention requirements are met. For FDA-regulated records, ensure Part 11 controls are satisfied.
How quickly must adverse events be reported?
Individual MDRs for deaths and serious injuries generally must be submitted within 30 calendar days under FDA MDR regulations; follow 21 CFR Part 803 for specific timelines and reporting conditions.
What audit evidence should accompany the report?
Provide source data extracts, complaint narratives, analytical methods, CAPA cross-references, and an unalterable audit trail showing reviewer actions and signatures to support inspection readiness.
Who is authorized to sign the report?
An authorized company official designated by internal delegation of authority should sign. Signatory must be able to attest to data accuracy and regulatory conformity; document the authorization.
How should records be stored long-term?
Retain the report and underlying records per retention policy: maintain active records while marketed and retain post-termination per applicable federal and state rules (HIPAA six years, IRS three years baseline) and your internal records schedule.

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