EMERGO SUMMARY OF KEY POINTS:

• The International Medical Device Regulators Forum is developing harmonized terminologies and codes to improve adverse event reporting across regulatory jurisdictions.
• More data-driven as opposed to text-based reporting terms will facilitate faster and more accurate adverse event reporting, according to the IMDRF.
• Most of the IMDRF’s adverse event reporting terms are still under development.

The International Medical Device Regulators Forum (IMDRF) has published a final draft of proposed terminologies for harmonized adverse event reporting for medical devices and IVDs.

The IMDRF document defines terms and codes intended to improve accuracy and effectiveness of adverse event reporting for both industry and regulatory agencies. The proposed terminologies are intended for use by both companies obligated to report adverse events to authorities and by regulators that monitor and analyze such events to protect public health.

The IMDRF’s proposed terms and codes are “readily usable, in contrast to narrative text, for more sophisticated approaches to signal detection…and trending analysis by incident management systems including advanced querying functions and data visualization,” enabling faster responses from regulators and manufacturers.

Four IMDRF adverse event terminology components

The IMDRF proposal lists four subsets of terms that would make up the overall adverse event terminology; each subset has its own alphanumeric code. Three of these four components remain under development.

• Annex A: Medical device problem terms and codes, used to capture problems occurring at a device level without identifying possible causes
• Annex B: Cause investigation terms and codes, under development
• Annex C: Patient problem terms and codes, under development
• Annex D: Component terms and codes, under development

These terminologies are being developed to support reporting of several issues: device-level observations, device components and accessories, patient- or user-level observations, and investigations into causes of an adverse event.

Additional resources for post-market adverse event and related reporting:

• Whitepaper: Post-market surveillance program implementation
• Whitepaper: Medical device vigilance reporting in Europe