As we begin analyzing the 2024 MDREngine data, some clear trends are emerging in medical device reporting. Here’s a look at the high-level numbers and what they tell us about the industry. This blog takes a closer look at the percentage growth, the top 10 MDR contributors, and the most frequently reported event types.
Major Findings
- There’s been a 13% increase in Initial MDRs compared to 2023.
- The FDA has received 2.6 million Initial MDRs and 870K Supplemental MDRs this year.
- An estimated 250 million complaints were reported to medical device companies in 2024.
Breakdown of 2.6M Initial MDRs
- 1.1 million involved injuries.
- 1.46 million were malfunctions.
- 16,000 reports involved deaths.
Where the Reports Came From
- 2.46M from manufacturers.
- 148K from distributors.
- 13K voluntary reports.
- 6K from user facilities.
Top MDR Submitters in 2024
Several companies submitted the highest number of reports, including Dexcom Inc., Medtronic, Straumann Group, Envista Holdings, Tandem Diabetes Care, Abbott Laboratories, Johnson & Johnson, Dentsply Sirona, Philips, and Becton Dickinson.
Devices Most Frequently Reported
Some of the most reported devices include:
- Dexcom G6 CGM and Dexcom G7 CGM
- T:SLIM X2 Insulin Pump (with Interoperable Tech & Control-IQ)
- Alaris System
- Dreamstation Auto CPAP
- Omnipod 5 Pod
- Minimed 780G Systems
- Libre 2 Sensor Freestyle
Key Takeaways
- Diabetes-related devices (CGMs and insulin pumps) dominate the reports. These devices are widely used and tend to generate more reports.
- Dental implant companies are also among the highest reporters, with Straumann, Nobel Biocare (Envista Holdings), and Dentsply Sirona leading the way.
- Philips has returned to the top 10 with a significant increase in reports for Dreamstation Auto CPAP, marking a notable shift from 2023.
This data highlights trends in medical device reporting and emphasizes the importance of continued monitoring and improvements in device safety. Stay tuned as we analyze these insights further!
Complaint Handling, MDRs, and the Need for Innovation Beyond QMS
Traditionally, Complaint Handling, MDR reporting, and Post-Market Surveillance have leaned on Quality Management Software (QMS), largely driven by their alignment with Quality Departments. CAPAs and Root Cause Investigations created a natural synergy. But as complaint and MDR volumes expanded dramatically, it became clear that QMS alone was no longer sufficient. Post-Market Surveillance is fundamentally different—it is a customer-focused extension rather than a quality-driven process. This dynamic nature, combined with the rapid pace of field findings, regulatory changes, and product updates, calls for a fresh, more adaptable approach to managing these challenges.
About Smarteeva
Based out of Santa Barbara, CA. Smarteeva Software provides cutting-edge and innovative Post Market Surveillance applications for the Medical Device industry. Smarteeva’s Complaint Handling, Adverse Event Reporting, Risk Management and Recall Management solutions prioritize compliance, organizational efficiencies and user-friendliness. Built on the Salesforce.com Platform utilizing the latest AI innovations and Machine Learning, Smarteeva Software provides a true partner to its business users.
For more information:
Reach us on : [email protected]
