How to Report Medical Device Adverse Events: A Regional Compliance Guide (US, EU, Canada, Japan, Australia)

Medical device safety depends on fast and accurate reporting of adverse events, especially when someone is harmed or nearly harmed while using a device. This guide explains how manufacturers, importers, and distributors must report these events in major regions: the United States, European Union, Canada, Japan, and Australia. We break down what counts as a reportable event, who must report it, and how quickly they must act.

1. United States (FDA – Medical Device Reporting/MDR)

Who Must Report:

• Manufacturers
  
• Importers
  
• Device user facilities (like hospitals)
  

What to Report:

• Deaths or serious injuries linked to the use of a medical device
  
• Device malfunctions that could cause harm if repeated
  

Reporting Timeframes:

• Death or serious injury:
  
  • Manufacturers: 30 calendar days
    
  • User facilities: 10 working days
    
• Malfunction (if likely to cause harm again):
  • Manufacturers: 30 calendar days
    
• 5-day reports:
  Required if the event needs prompt action to reduce public health risk.
  

How to Report:

• Submit through the FDA’s Electronic Medical Device Reporting (eMDR) system.
  
• Use Form 3500A for mandatory reports.
  

Reference: 21 CFR Part 803 (Medical Device Reporting regulation)

2. European Union (MDR 2017/745 – Vigilance Reporting)

Who Must Report:

• Manufacturers
  
• Authorized representatives (if the manufacturer is outside the EU)
  

What to Report:

• Any serious incident involving a device already on the market
  
• Field Safety Corrective Actions (FSCAs), e.g., recalls, field corrections
  

Reporting Timeframes:

• Death or serious public health threat: Within 2 days
  
• Serious injury or incident: Within 10 days
  
• Others: Within 15 days
  

How to Report:

• Submit reports to national competent authorities (NCAs) via EUDAMED (EU medical device database)
  
• Include a Manufacturer Incident Report (MIR) form
  

Reference: EU MDR Articles 87–92

3. Canada (Health Canada – Mandatory Problem Reporting)

Who Must Report:

• Manufacturers
  
• Importers
  

What to Report:

• Incidents involving death, serious deterioration in health, or potential for such harm
  
• Device issues that might lead to recall or FSCA
  

Reporting Timeframes:

• Death or serious health threat: Within 10 calendar days
  
• Other serious incidents: Within 30 calendar days
  

How to Report:

• Submit through Health Canada’s online Medical Device Problem Report form
  
• Reports must be in English or French
  

Reference: Medical Devices Regulations (SOR/98-282), Sections 59–61.1

4. Japan (PMDA – Pharmaceuticals and Medical Devices Agency)

Who Must Report:

• Marketing Authorization Holders (MAHs)
  

What to Report:

• Malfunctions or defects that led to or might lead to injury/death
  
• Infections, deaths, or severe injuries linked to the device
  
• Overseas adverse events, if related to devices sold in Japan
  

Reporting Timeframes:

• Serious injury/death:
  • Within 15 days
    
• Malfunctions that could lead to injury or death:
  • Within 30 days
    

How to Report:

• Submit through PMDA’s reporting portal
  
• Use designated GVP (Good Vigilance Practice) forms and codes
  

Reference: Pharmaceutical and Medical Device Act (PMD Act), Articles 68-10 to 68-16

5. Australia (TGA – Therapeutic Goods Administration)

Who Must Report:

• Sponsors (authorized importers or manufacturers)

What to Report:

• Any event where a device caused or might have caused:
  
  • Death
    
  • Serious injury
    
  • Serious public health risk
    
• Field actions and recalls
  

Reporting Timeframes:

• Death or serious threat to public health: Within 2 days
  
• Serious injury or long-term harm: Within 10 days
  
• Other incidents: Within 30 days
  

How to Report:

• Submit via the TGA’s Incident Reporting and Investigation Scheme (IRIS)
  
• Use online forms or email reports to the TGA
  

Reference: Therapeutic Goods (Medical Devices) Regulations 2002

6. What Is a “Reportable Event”?

Although each country defines it slightly differently, the following are almost always reportable:

• Death linked to the device
  
• Serious injury or illness
  
• Malfunction that could cause harm
  
• Incorrect use due to design flaw or confusing instructions
  
• Device mix-up or labeling error
  
• Contamination or sterility failure
  
• Battery or power failures in life-sustaining devices
  

7. What Is Not Usually Reported?

Not every problem needs reporting. Common exclusions include:

• Expected side effects clearly stated in the labeling
  
• Malfunctions caught before device use (no risk to patients)
  
• User mistakes that don’t result in harm (unless repeated or likely)
  

8. Good Reporting Practices

• Act fast, don’t wait for full investigation to submit an initial report
  
• Keep clear records, store incident logs, photos, and test data
  
• Communicate globally, if the device is sold in more than one country, check whether the same issue was reported elsewhere
  
• Follow up, many systems require a final report after the initial notification
  

9. Penalties for Failing to Report

Missing reports or delayed submissions can lead to:

• Product seizures
  
• Fines and sanctions
  
• Loss of market authorization
  
• Facility inspections
  

In some regions, failing to report a known safety issue can trigger civil or criminal penalties, especially if harm results from non-reporting.

10. Summary Table of Reporting Rules

Final Thoughts

Reporting adverse events isn’t just about rules. It helps protect patient lives and improve medical technology. By knowing what to report and how quickly to act, medical device companies can meet their legal duties and support public health.

Every region has its own steps, but the goal is the same: find problems early, reduce harm, and keep the devices people trust safe to use.

Whether you’re based in the U.S. or distributing devices globally, following the right reporting paths builds stronger products, and safer outcomes.