How do vigilance and FSCA reporting work with an EU Authorized Representative?

## How Do Vigilance and FSCA Reporting Work with an EU Authorized Representative? The EU requires reporting of **serious incidents** and **Field Safety Corrective Actions (FSCAs)** to competent authorities. Understanding the EU AR's role in this process is essential for maintaining compliance and patient safety. ### EU Vigilance Requirements Under MDR and IVDR, manufacturers must report: 1. **Serious incidents** - Events that meet the definition of a serious incident under MDR/IVDR 2. **Field Safety Corrective Actions (FSCAs)** - Actions taken to reduce risks from devices already on the market 3. **Trend reporting** - Patterns of incidents that may indicate systemic issues ### The EU AR's Key Role Article 11 of MDR and IVDR puts the EU AR in a **key assurance role** for vigilance: The EU AR is responsible for **ensuring** that reports are sent to competent authorities for: - Serious incidents occurring in the EU - FSCAs in the EU - Trend reporting as required **Important**: The EU AR doesn't just "facilitate" reporting—they are responsible for **ensuring** it happens. ### For Foreign Manufacturers MDR/IVDR also indicate that the **authorized representative should be included in relevant FSCA communications**. This means: - The EU AR should be notified of FSCAs - The EU AR should be involved in the reporting process - The EU AR should be kept informed of corrective actions ### Practical Workflow A well-functioning vigilance workflow should include: #### 1. **Complaint/Incident Intake** - Receive and log complaints or incident reports - Triage against "serious incident" criteria - Determine if the incident occurred in the EU #### 2. **Triage Against Criteria** - Assess whether the incident meets the definition of "serious incident" - Determine reporting requirements and timelines - Identify if FSCA is needed #### 3. **Draft Competent Authority Report** - Prepare the incident report in the required format - Include all required information - Coordinate with EU AR for review and submission #### 4. **Submit + Track CAPA/FSCA** - Submit report to competent authority through appropriate channels - Track submission and any follow-up requests - Implement corrective and preventive actions (CAPA) - Submit FSCA notifications if required #### 5. **Closeout Evidence** - Document that reporting is complete - Maintain records of submissions and responses - Update risk management files ### Reporting Timelines While specific timelines may vary, you should: - **Report serious incidents promptly** - Typically within days, not weeks - **Notify EU AR immediately** - Don't wait to involve them - **Coordinate with EU AR** - They need to ensure submission happens - **Track and follow up** - Ensure competent authority receives and processes the report ### EU AR Responsibilities Your EU AR should: - ✅ Have a clear process for receiving incident notifications - ✅ Review reports before submission - ✅ Submit reports to competent authorities in required format - ✅ Track submissions and follow up as needed - ✅ Coordinate with you on any competent authority requests - ✅ Maintain records of all vigilance activities ### What to Ask Your EU AR 1. **"What is your process for handling serious incident reports?"** - How quickly can they review and submit? - What format do they require from you? 2. **"Do you actively manage reporting, or do you rely on us to draft everything?"** - Some EU ARs draft reports, others review manufacturer drafts - Understand the division of labor 3. **"How do you track submissions and ensure competent authorities receive them?"** - You need confirmation that reports were submitted - Track record of successful submissions 4. **"What happens if competent authorities ask follow-up questions?"** - Who responds? - How quickly? - What information do they need from you? ### Best Practices 1. **Establish Clear Processes** - Document your vigilance workflow 2. **Communicate Early** - Notify EU AR as soon as you identify a reportable incident 3. **Maintain Records** - Keep detailed records of all incidents and reports 4. **Regular Review** - Review your vigilance process with EU AR periodically 5. **Train Your Team** - Ensure your team knows when and how to report ### Common Mistakes - ❌ Waiting too long to notify EU AR - ❌ Not including EU AR in FSCA communications - ❌ Assuming EU AR will handle everything without your input - ❌ Not maintaining proper records - ❌ Not following up on submissions ### Next Steps 1. Establish clear vigilance workflows with your EU AR 2. **[Compare EU Authorized Representative providers & request quotes](https://cruxi.ai/regulatory-directories/eu_ar)** - Find providers with strong vigilance reporting capabilities --- *Written by **Lo H. Khamis**, Regulatory Experts. [Connect on LinkedIn](https://www.linkedin.com/in/lo-h-khamis) for regulatory guidance.* ### Official Sources: - [Regulation (EU) 2017/745 (MDR) - Article 87, Article 88](https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32017R0745)