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Labeling Requirements for Medical Devices

FDA UDI RegulationsEU MDR Regulations
1. Minimize Medical Errors1. Make devices traceable
2. Offer easy integration of device usage information into the data systems.2. It makes the post-market safety-related activities more effective.
3. Allows in easily tracking medical devices with adverse events.3. Advanced reporting of incidents
4. It helps in resolving the reported issues faster.4. It provides corrective actions on safety for a particular field.
5. Device recalls get resolved much faster with immense efficiency.5. Ensures that the competent authorities can monitor effectively.
6. Focused on communicating the FDA’s safety measures effectively.6. Minimizes medical errors
7. It provides a standardized format to input dates on a device label.7. It helps in fighting devices with false descriptions.
8. Added Advantages 8. Allows health institutions to enhance purchasing power, enhances policies for waste disposal and stock management.

With a continuous series of changes in Medical Device Labeling Requirements, manufacturers are finding it difficult to remain in compliance. The rising need for consumer safety requires better communication of the user details. The issues with labeling would persist until and unless it is solved in a systematic manner and with proper guidance.