Manufacturer Investigation Reports (MIRs) are critical documents used to assess complaints, adverse events, and product quality issues associated with medical devices and in vitro diagnostic (IVD) products. Effective handling of these reports ensures that potential risks to patients and users are promptly identified, investigated, and addressed.
The process involves reviewing reported incidents, evaluating root causes, assessing product performance, and determining appropriate corrective and preventive actions (CAPA). Timely and thorough investigation supports regulatory compliance, enhances product safety, and contributes to continuous quality improvement.
Organizations handling MIRs should maintain clear procedures for report review, documentation, communication with manufacturers and regulatory authorities, and follow-up actions to ensure patient safety and product effectiveness. Please, submit all manufacturer investigation reports for Medical Devices and IVDs to: pharmacovigilance@nafdac.gov.ng
Click to report adverse events associated with the use of Medical Devices and IVDs
