The discussion focuses on replacing generic descriptions or internal codes with a hierarchically standardized international structure. The IMDRF proposes a set of codes that categorize incidents into logical levels, allowing for much more robust data analysis.

What does this mean in practice for manufacturers and importers?

End of Subjectivity: Instead of describing a problem in free text or broad categories, companies must use specific IMDRF codes to identify:

• Medical Device Problem;
• Type of Investigation / Cause;
• Patient Outcome;
• Component / Part.

Global Traceability: By adopting these codes, an adverse event occurring in Brazil can be automatically compared with databases in Europe or the US, facilitating the detection of global risk signals.

System Revision: Electronic Quality Management Systems (eQMS) and complaint investigation forms will need to be adapted to include fields for this new coding system.

Impacts and Deadlines

This transition is not just a change of “labeling,” but a culture shift in post-market risk analysis.

Operational Impact: Techno vigilance teams will need training to interpret and apply the correct codes. Incorrect classification could trigger unnecessary sanitary alerts or mask real risks.

Procedures (SOPs): All procedures involving Customer Service (SAC), complaint handling, and notification to Anvisa (Notivisa) must be revised.

Timeline: Although Anvisa has signaled the start of implementation, compliance efforts should begin immediately. The expectation is that the notification system will soon require these fields mandatorily, and companies that wait until the last minute will face technical difficulties in submitting mandatory reports.