Revised IMDRF Glossary for Medical Devices: Focus on Defect Reporting and Terminology Structure

The International Medical Device Regulators Forum (IMDRF) has updated its Glossary for Medical Devices, with an emphasis on defect reporting and terminology structure. The revised glossary will be available on the Pharmaceuticals and Medical Devices Agency (PMDA) website, and it includes Japanese translations of terminology levels and codes.

Key Highlights of the Revised Glossary:
Focus Areas:

The updated glossary covers various aspects of medical device safety, including:
Adverse events
Data and security issues
Labeling and information issues
Environmental and manufacturing issues
Safety and mechanical components
Defect Reporting:

The glossary introduces standardized terminology to streamline the reporting and investigation of defects and issues in medical devices.
Common Issues Addressed:

Unauthorized access
Data loss
Backup failures
Inaccurate labeling
Unreadable information
Lack of maintenance documentation
The glossary's revisions aim to ensure a more uniform and clear approach to defect reporting and terminology across the medical device industry, facilitating better communication and regulatory oversight.

Source: https://savvy.praise-net.jp:8443/Analysis/

Region: Japan