As the EU MDR transition deadline is inching closer, manufacturers must execute the labeling requirements with utmost priority and caution and must ensure high standards of quality, and safety for compliance. Prior to execution, understanding the new labeling requirements and accurate implementation is of paramount importance. Any labeling errors can impede the progress, cause product recalls and lead to costly delays.
Therefore, the key is to carefully prepare the medical devices labels aligning with the EU MDR labeling requirements, such as:
EU MDR Labeling Requirements
- Manufacturers should include the name and trade name of the device and the manufacture date, if there is no expiration date.
- All the labels must have a standardized symbol, which indicates that the package shipped into the EU contains a medical device.
- The label must have the necessary details for a user to identify the contents of the packaging and its intended purpose.
- The licensed EU representative information should be showcased on the label, in case a medical device manufacturer is based out of the EU.
- For using or implanting the device safely, the time limit should be expressed on the label in terms of the year and month.
- The device labeling must be provided with the warnings, instructions, precautions, or contradictions that need to be brought to the immediate attention of the user, while in use.
- A General Safety and Performance Requirements (GSPR) checklist is required to be showcased on the labels along with a summary of safety and clinical performance for Class III and implantable devices.
- Web address along with the eIFU (electronic Instructions for Use).
- Device labeling should be published electronically on the manufacturer’s website as well as in print and the manufacturers are required to publish user data on their websites as well.
- The label should have a Unique Device Identification (UDI) carrier. A UDI must include, unique identifying “part numbers” issued by a neutral party and assigned to the finished products, product packaging with UDI label, UDI on the product itself (direct part marking) for some products and UDIs must be registered in EUDAMED database.
- The composition of the UDI symbol must be inclusive of Device Identifier (DI) and Production Identifier (PI).
- The labels may be supplemented by machine-readable information and must be provided in a human-readable format.
- Along with quantitative information on the main constituent(s), the labels must include overall composition for devices with materials absorbed or locally dispersed in the body.
- The requirements for sterile barrier labeling should be explicitly stated and include, sterile barrier identification, sterilization method, declaration of the sterile condition (e.g. sterile, non-sterile), manufacture date and expiration date (month and year) and directive to check IFU if the package appears damaged.
Finally, to make your medical device label EU MDR-ready, the major challenge lies in understanding and implementing the aforementioned labeling requirements. Failure to implement accurate procedures will lead to unnecessary compliance complexities and result in costly product recalls. Therefore, manufacturers must be familiar with the new EU MDR labeling requirements. How effective are your device labels? Are they aligned with the requirements? Approach a Regulatory device labeling expert for clear-cut evaluation. Stay informed. Stay compliant.