To ensure high standards of quality and safety for medical devices being produced or supplied, the European Union (EU) has released a new Medical Device Regulation (MDR) in May 2017. As the three-year transition period for medical device manufacturers will come to an end from May 26th, 2020, organizations must relook at implementing compliant processes and procedures accordingly.
For many medical device manufacturers, the overall impact of the EU MDR on labeling is still uncertain. Specific to labeling, the EU MDR has expanded requirements and initiatives towards increased transparency and traceability of the devices. Thus, the MDR has laid out requirements for the organizations to include more information on their labels, than it was previously required. The information manufacturers must include on the medical devices is as below:
- The name and trade name of the device
- All labels must include a standardized symbol to indicate that, the package being shipped into the EU contains a medical device
- The details strictly necessary for a user to identify the contents of the packaging and its intended purpose
- Information of the licensed EU representative, in case a medical device manufacturer is based out of the EU
- The time limit for using or implanting the device safely is expressed in terms of the year and month
- Warnings and precautions that need to be taken while using the device
- The serial number for an active implantable device and for other implantable devices, the serial number, and the lot number
- Instructions for Use (IFUs)
- Unique Device Identification (UDI)
- Labels must be provided in a human-readable format and may be supplemented by machine-readable information
It is important to note that the enforcement deadline for the above-mentioned requirements is just around the corner. Hence, organizations must execute the new format of labeling information with utmost priority and caution. They must also maintain transparency across all label assets; from individual symbols and statements to label layouts and templates, Instructions for Use (IFUs), booklets, and other promotional materials.
With the compliance deadline for the EU MDR approaching fast, it is important for manufacturers or market entrants to immediately collate their clinical/pre-clinical safety data and assess its usability as per the updated regulations as quickly as possible. Are you game for the EU MDR labeling requirements and compliance? Evaluate right now.