Traditionally, MedDRA has had a biopharmaceutical focus, and the number of device-related terms has been minimal. Beginning in 2004, the MSSO began receiving an increased number of change requests to add device related terms. This increased number of device related change requests appears to be driven by the increased emphasis given to combination products.

Through interaction with device manufacturer subscribers, pharmaceutical companies, and regulatory representatives, we explored the possibility of allowing MedDRA to adopt terms related to device regulatory needs. As a result of this exploration, the MSSO has developed a policy to respond to MedDRA subscriber requests that fall into the category of concepts that identify: 1) a device malfunctioning event, e.g., PT Cardiac pacemaker malfunction, 2) a device component finding, e.g., LLT Broken lead cardiac pacemaker, or 3) a device related complication, e.g., PT Device related infection.

We encourage you to monitor this web site and related communications (e.g., MedDRA Messenger) for updated information. If you would like additional information on a specific issue, please contact the MSSO Help Desk at mssohelp@ngc.com. Please click here to submit your feedback. Subscribers are also invited to submit comments on the MedDRA Forum.

Thank you

MedDRA MSSO