How do vigilance and FSCA reporting work with a UK Responsible Person?

## How Do Vigilance and FSCA Reporting Work with a UK Responsible Person? The UK requires reporting of **serious incidents** and **Field Safety Corrective Actions (FSCAs)** to MHRA. Understanding the UK RP's role in this process is essential for maintaining compliance and patient safety. ### UK Vigilance Requirements Under UK MDR 2002, manufacturers must report: 1. **Serious incidents** - Events that meet the definition of a serious incident under UK MDR 2002 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 UK RP's Key Role UK MDR 2002 puts the UK RP in a **key assurance role** for vigilance: The UK RP is responsible for **ensuring** that reports are sent to MHRA for: - Serious incidents occurring in the UK - FSCAs in the UK - Trend reporting as required **Important**: The UK RP doesn't just "facilitate" reporting—they are responsible for **ensuring** it happens. ### For Foreign Manufacturers UK MDR 2002 also indicates that the **responsible person should be included in relevant FSCA communications**. This means: - The UK RP should be notified of FSCAs - The UK RP should be involved in the reporting process - The UK RP 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 UK #### 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 MHRA Report** - Prepare the incident report in MHRA's required format - Include all required information - Coordinate with UK RP for review and submission #### 4. **Submit + Track CAPA/FSCA** - Submit report to MHRA 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 UK RP immediately** - Don't wait to involve them - **Coordinate with UK RP** - They need to ensure submission happens - **Track and follow up** - Ensure MHRA receives and processes the report ### UK RP Responsibilities Your UK RP should: - ✅ Have a clear process for receiving incident notifications - ✅ Review reports before submission - ✅ Submit reports to MHRA in required format - ✅ Track submissions and follow up as needed - ✅ Coordinate with you on any MHRA requests - ✅ Maintain records of all vigilance activities ### What to Ask Your UK RP 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 UK RPs draft reports, others review manufacturer drafts - Understand the division of labor 3. **"How do you track submissions and ensure MHRA receives them?"** - You need confirmation that reports were submitted - Track record of successful submissions 4. **"What happens if MHRA asks 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 UK RP 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 UK RP periodically 5. **Train Your Team** - Ensure your team knows when and how to report ### Common Mistakes - ❌ Waiting too long to notify UK RP - ❌ Not including UK RP in FSCA communications - ❌ Assuming UK RP will handle everything without your input - ❌ Not maintaining proper records - ❌ Not following up on submissions ### Next Steps 1. Establish clear vigilance workflows with your UK RP 2. **[Compare UK Responsible Person providers & request quotes](https://cruxi.ai/regulatory-directories/uk_rp)** - 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: - [MHRA - Vigilance Reporting](https://www.gov.uk/government/organisations/medicines-and-healthcare-products-regulatory-agency)