Medical Devices Labeling Checklist for EU MDR Compliance

Manufacturers must conduct the labeling criteria with utmost priority and caution as the EU MDR transition deadline approaches, and must maintain high levels of quality and safety for enforcement. Prior to implementation, it is important to consider the current labeling standards and ensure that they are correctly implemented. Any labeling errors may lead to Product Recalls and trigger costly affair to the manufacturer.

As a result, it’s important to carefully plan medical product labels that comply with EU MDR labeling criteria, such as:

Medical Device Labeling Requirements as per EU MDR:

• If there is no expiration date, manufacturers should include the device’s name and trade name, as well as the manufacturing date.
• A Standardized Symbol/Logo/ ICON must appear on all labels of the Product, indicating that the product being delivered into the Europe Union includes a medical device.
• The label must provide all of the information needed for a customer to recognize the packaging’s contents and intended use.
• If a medical device manufacturer is located outside of the EU, the approved licensed EU representative details should be prominently displayed on the label.
• The time limit should be expressed on the label in terms of the year and month for safely using or implanting the product.
• The Medical Device label must be listed with the warnings, instructions, precautions, or contradictions that need to be brought to the immediate attention of the user, while in use.
• The Unique Device Identification (UDI) carrier should  be present on the each label. Unique identifying “part numbers” issued by a neutral party and allocated to finished products, product packaging with UDI logo, UDI on the product itself (direct part marking) for certain products, and UDIs must be registered in the EUDAMED database are all necessary components of a UDI.
• Web address along with the eIFU (electronic Instructions for Use).
• Device Identifier (DI) and Production Identifier (PI) must be included in the UDI symbol’s composition (PI).
• Machine-readable information can be added to the labels, which must be given in a human-readable format.
• For devices with absorbent materials, the labels must provide overall composition in addition to quantitative details on the key constituent(s).

Finally, recognizing and enforcing the above EU MDR labeling criteria is the most difficult part of making your medical device label EU MDR Compliant. Failure to follow proper protocols would result in needless Regulatory enforcement issues and expensive product recalls. As a result, manufacturers must be aware of the latest MDR labeling standards in the EU. What is the effectiveness of your device labels? Are they in line with the specifications? For a straightforward assessment, contact a Regulatory Device Labeling specialist. Keep yourself up to date. Maintain your composure.

CATEGORY:  Medical Devices, Regulatory Affairs

Keywords:  Medical Devices, European Union, EU MDR, EU IVDR, MEDICAL DEVICE labeling, eIFU (electronic Instructions for Use)), MDR, Product label, Unique Device Identification (UDI), Device Identifier (DI), Production Identifier (PI), UDI PI – UDI symbol’s composition (PI).