The EU Medical Devices Regulation (EU MDR Regulation) replaced the Medical Device Directive (MDD) and introduced stricter medical device labeling rules to ensure better transparency, quality, and patient safety in line with global standards. Manufacturers must comply with these updated regulations to market medical devices in the EU.

Labeling is critical for safe device use; and symbols are used to communicate essential information on the device label to ensure proper handling and adherence to regulatory standards. The regulation requires all devices to include a Unique Device Identification (UDI) to improve traceability and support post-market surveillance, as outlined in Chapter III, Annex I, Section 23.2 of the EU MDR 2017/745.

Information required on the label:

As per MDR the following information must be made available on the label to ensure adherence to regulation and obtain CE mark.

  • Device name/Trade name
  • Information required to identify the device
  • Manufacturer’s name& address
  • Authorized representative’s name &address
  • Medicinal substance indication (if applicable)
  • Tissue/cell origin indication (if applicable)
  • Lot/serial number
  • UDI carrier
  • Manufacture date& Expiry date
  • Storage/handling conditions
  • Sterile indication
  • Sterilization method
  • Warnings/precautions
  • Single-use indication (if applicable)
  • Reprocessed device indication (if applicable)
  • Medical device indication
  • Custom-made device indication (if applicable)
  • Clinical investigation indication (if applicable)
  • Composition (if applicable)
  • Serial/lot number for implantable devices

Greater Focus on Patient Safety and Transparency

The primary goal of EU MDR 2017/745 is to enhance patient safety. Medical device labels are now required to deliver more detailed information to healthcare professionals and end users. This includes important warnings which need immediate attention, storage conditions, time limits etc. These Improvements are designed to reduce the risk of misuse and empower end users to make informed choices.

Transparency has been significantly enhanced through the establishment of the European Database on Medical Devices (EUDAMED). Labels must now incorporate a Unique Device Identifier (UDI) to improve traceability, streamline recall processes, and provide patients and regulatory authorities with access to critical information about medical devices.

Key Update in Medical Device Labelling under EU MDR

Unique Device Identification (UDI):

The Unique Device Identification (UDI) system is a mandatory requirement for all medical devices, aimed at enhancing traceability, supporting post-market surveillance, and prevent counterfeiting. It facilitates regulatory authorities in monitoring devices, streamlines inventory management, simplifies recall processes, and reduces errors caused by incorrect device identification. Implementing the UDI system is a critical component of the technical documentation required to obtain the CE mark. Every medical device must include a UDI on its label, which comprises two components: the Device Identifier (DI) and the Production Identifier (PI). The UDI enhances traceability and ensures compliance with global standards.

Enhanced Label Content Requirements:

According to the MDR, labels must provide comprehensive information, including the storage conditions, sterility status, single use or reusable, expiration dates and important warning which need immediate attention. They must also specify the time limit for safe use or implantation and include a standardized symbol indicating that the product is a medical device. If the device is custom-made, it must be labeled with the words ‘Custom-Made Device’. Also, MDR mandate to include the statement on the label “CHECK THE INSTRUCTIONS FOR USE IF THIS PACKAGING HAS BEEN FOUND OPEN BEFORE USE OR DAMAGED”. Adhering to these labeling requirements is essential for obtaining the CE mark.

Standardized Symbols:

Symbols and Pictograms: Standardized symbols must be utilized to communicate essential information. Defined by international standards such as ISO 15223-1, these symbols minimize the need for text and promote universal comprehension. The use of internationally recognized symbols is emphasized to reduce language barriers and ensure consistent communication of key device characteristics across the EU. Manufacturers should use internationally recognized symbols, promoting clarity, efficiency, and cost savings while ensuring safe and effective device use.

Language Localization:

Labeling must be provided in the official language(s) of the EU Member States where the device is marketed, ensuring accessibility and clarity for all users. This requirement also needs to be met to obtain a CE mark for a product.

Expiration Dates and Lot Numbers:

 It is now mandatory to include expiration dates, lot numbers, or serial numbers, offering end users clear information regarding the device’s usability and traceability.

Reprocessed Single-Use Devices:

EU MDR 2017/745 introduces specific requirements for reprocessed single-use medical devices to ensure their safety and effectiveness. The label must clearly indicate that the device is reprocessed. It must include the term “REPROCESSED” and provide information on the number of reprocessing cycles already performed and any limitations regarding the number of reprocessing cycles.

Restricted Substances:

If restricted substances like CMR or endocrine-disrupting substances are present in amounts greater than 0.1% (w/w), they must be clearly stated on the label or packaging of each unit.

 

 

Conclusion:
The EU MDR 2017/745 has changed medical device labeling to focus more on patient safety, transparency, and international consistency. It requires features like Unique Device Identification (UDI), detailed label information, standard symbols, language requirements, and clear labeling of restricted substances. These changes help improve traceability, safety, and compliance with regulations. Manufacturers must follow these rules to get the CE mark and keep their products available in the EU, showing their commitment to quality and patient care. Overall, the EU MDR builds trust in medical devices and meets the growing needs of global healthcare systems.

Author name: Sherin Joseph

Sr. Consultant, MDR Technical Expert