Guidelines for Pharmacovigilance Medical Device Reporting
1) Purpose
The purpose of this SOP is to establish procedures for reporting adverse events associated with medical devices in compliance with regulatory requirements.
2) Scope
This SOP applies to personnel involved in pharmacovigilance activities related to medical devices, including pharmacovigilance officers, medical device safety specialists, and regulatory affairs professionals.
3) Responsibilities
The Pharmacovigilance Medical Device Safety Specialist is responsible for overseeing medical device adverse event reporting. Pharmacovigilance officers and safety scientists ensure accurate and timely reporting of medical device adverse events.
4) Procedure
4.1 Medical Device Adverse Event Identification
- Receive adverse event reports associated with medical devices from healthcare professionals, consumers, clinical studies, and post-market surveillance.
- Assess reported adverse events to determine potential association with medical device use.
4.2 Medical Device Reporting Requirements
- Classify adverse events according to severity, impact on patient safety, and regulatory reporting criteria.
- Follow regulatory guidelines (e.g., FDA, EU MDR) for reporting requirements, including timeframes for initial and follow-up reports.
4.3 Adverse Event Documentation and Coding
- Document detailed adverse event information, including patient demographics, medical device details, adverse event description, and clinical outcomes.
- Assign appropriate coding (e.g., MedDRA, ICD) to adverse events for standardized reporting and data analysis.
4.4 Reporting to Regulatory Authorities
- Prepare and submit initial and follow-up adverse event reports to regulatory authorities (e.g., FDA, EMA) as per regulatory requirements.
- Ensure completeness and accuracy of adverse event reports to facilitate regulatory review and decision-making.
4.5 Follow-up and Communication
- Follow up with stakeholders (e.g., healthcare providers, consumers) to obtain additional information or clarify adverse event details as needed.
- Communicate adverse event reporting updates and outcomes internally and externally as required by regulatory authorities.
4.6 Quality Assurance and Compliance Monitoring
- Conduct quality assurance checks on medical device adverse event reports to verify compliance with SOPs and regulatory guidelines.
- Monitor and evaluate compliance with regulatory reporting requirements through internal audits and assessments.
5) Abbreviations, if any
PV – Pharmacovigilance, SOP – Standard Operating Procedure, FDA – Food and Drug Administration, EU MDR – European Union Medical Device Regulation, MedDRA – Medical Dictionary for Regulatory Activities, ICD – International Classification of Diseases
6) Documents, if any
Medical device adverse event reporting forms, adverse event coding guidelines, regulatory reporting templates.
7) Reference, if any
FDA Medical Device Reporting (MDR) Regulations, EU MDR (2017/745), MedDRA MSSO – Medical Dictionary for Regulatory Activities Maintenance and Support Services Organization.
8) SOP Version
Version 1.0
