How to File an MDR Complaint - Medical Device Regulation Europe

Understanding the MDR Complaint Process

The Medical Device Regulation (EU) 2017/745 (MDR) establishes a comprehensive framework for ensuring medical device safety in Europe. When devices fail to meet these standards, formal complaints serve as a critical mechanism for regulatory enforcement.

Legal Basis for Complaints

Article 93: Vigilance and Post-Market Surveillance

Article 93 of the MDR requires competent authorities to:

Evaluate all information from market surveillance activities
Take appropriate measures when devices present unacceptable risks
Coordinate with other Member States on enforcement actions

Article 87: Reporting of Serious Incidents

Manufacturers must report serious incidents, but when they fail to do so, third parties can file complaints to alert authorities.

Steps to File a Formal Complaint

1. Gather Evidence

Before filing a complaint, compile comprehensive documentation:

Product identification: Name, model, manufacturer details
Regulatory violations: Specific MDR articles violated
Evidence: Screenshots, photos, documentation
Risk assessment: Potential harm to patients
Timeline: When violations were discovered

2. Identify the Competent Authority

Each EU member state has a designated competent authority for medical devices:

Germany: BfArM (Federal Institute for Drugs and Medical Devices)
France: ANSM (National Agency for the Safety of Medicines)
Spain: AEMPS (Spanish Agency for Medicines and Medical Products)
Italy: Ministry of Health - Medical Devices Division

3. Structure Your Complaint

A properly formatted complaint should include:

Executive Summary

Brief overview of the violation and its severity

Device Information

Device name and intended use
Manufacturer and distributor details
CE marking status (if applicable)
Risk classification (Class I, IIa, IIb, or III)

Specific Violations

Reference specific MDR requirements:

Article 10: General obligations of manufacturers
Article 20: CE marking requirements
Article 52: Conformity assessment procedures
Annex I: General safety and performance requirements

Supporting Evidence

Documentation of missing IFU (Instructions for Use)
Screenshots of misleading claims
Evidence of lacking certification
Proof of fraudulent CE marking

Risk Assessment

Explain potential patient harm and public health implications

4. Submit the Complaint

Most competent authorities accept complaints through:

Online portals
Email submissions
Formal mail correspondence

Include all supporting documentation and maintain copies for your records.

What Happens After Filing

Initial Review (1-2 weeks)

The authority acknowledges receipt and assigns a case number

Investigation Phase (1-3 months)

Technical assessment of the device
Review of manufacturer documentation
Coordination with notified bodies

Enforcement Actions

Possible outcomes include:

Product recall or withdrawal
Corrective actions by manufacturer
Suspension of CE marking
Legal proceedings
Public safety notices

Benefits of Using MD Watchdog

While individuals can file complaints directly, MD Watchdog offers significant advantages:

Professional Documentation

Our regulatory experts ensure complaints meet technical standards and reference appropriate regulations.

Anonymity Protection

We file complaints on behalf of the community, protecting individual reporters from potential retaliation.

Expert Review

Volunteer professionals with quality management experience review each case thoroughly.

Comprehensive Follow-up

We track complaint status and push for appropriate regulatory action.

Reduced Burden

Filing a proper complaint requires significant time and expertise - we handle the complex process for you.

Common Pitfalls to Avoid

Insufficient Evidence

Vague allegations without documentation rarely lead to action. Always provide concrete proof.

Wrong Authority

Ensure you’re contacting the correct competent authority for the device’s location of sale.

Missing Technical Details

Include specific regulatory violations, not just general concerns about safety.

Emotional Language

Maintain professional, factual tone focused on regulatory compliance.

Case Study: Successful MDR Complaint

A diagnostic app claiming to detect skin cancer was found operating without proper certification. The complaint documented:

Violation of Article 5: Device placed on market without conformity assessment
Violation of Annex I, Section 23: Missing Instructions for Use
Risk Classification Error: Operating as unregistered Class III device

Result: App removed from EU app stores within 60 days, manufacturer fined €250,000

When to File a Complaint

Consider filing when you observe:

Medical devices without proper CE marking
False or misleading medical claims
Missing essential documentation (IFU, labels)
Devices causing unexpected adverse events
Software medical devices without proper classification

Alternative Reporting Channels

Besides competent authorities, consider:

EUDAMED Database

Report directly to the European Database on Medical Devices

National Vigilance Systems

Each country maintains specific reporting systems for adverse events

Consumer Protection Agencies

For devices sold directly to consumers

Conclusion

Filing MDR complaints is a civic responsibility that protects patients across Europe. While the process can be complex, proper documentation and understanding of regulatory requirements increase the likelihood of successful enforcement action.

MD Watchdog simplifies this process by providing expert review, professional documentation, and anonymous submission. Our volunteer professionals ensure your concerns reach authorities in the most effective format possible.

Take Action

If you’ve identified a potentially non-compliant medical device, don’t wait. Patient safety depends on timely reporting of regulatory violations.

Submit a claim through MD Watchdog - Our experts will review your submission and file a comprehensive complaint with the appropriate authorities.