Labeling

The new MDR has expanded labeling requirements to increase transparency and traceability of medical devices. These changes will most likely impact manufacturers’ labeling processes and may require the use of different labeling equipment.

Device labeling must include:

• Device name and trade name
• Standardized symbol to indicate that the product is a medical device
• Package contents and intended purpose
• Contact information of authorized EU representative (for non-EU based manufacturers)
• Unique device identifier (UDI)
• Time limit for using or implanting the device safely (i.e., year and month)
• Warnings and precautions related to the device
• Serial number and lot number (for implantable devices)
• Links to electronic instructions for use (eIFUs) and company website
• Indication of any carcinogenic, mutagenic, or toxic for reproduction (CMR) substances
• Indication of any substances having endocrine-disrupting properties
• Indication of medicinal substances, human blood or plasma derivatives, or tissues or cells of human or animal origin
• Number of reprocessing cycles (for single-use devices)

The unique device identifier (UDI) requirement is a significant change that has been introduced under the new regulation. Comprised of a series of numeric or alphanumeric characters, the UDI allows for the unambiguous identification of specific devices on the EU market and enables better traceability and monitoring by authorities. In addition to being added to device labeling, the UDI information must also be listed on the declaration of conformity and uploaded to the European database for medical devices (EUDAMED).

All medical device labels should be presented in a human-readable format. As such, manufacturers may need to increase the sizes of labels or use internationally recognized symbols (per ISO 15223-1) to accommodate more information.