Mandatory Label Elements and Common Errors in Medical Device Labelling under MDR

Medical device labelling is a fundamental aspect of regulatory compliance within the European Union. Article 10(11) of Regulation (EU) 2017/745 (MDR) mandates manufacturers to ensure devices are accompanied by information for safe and proper use. This includes information on the label and in the instructions for use.

Distributors and importers have specific responsibilities regarding labelling. They must verify that devices bear the CE marking and are labelled in accordance with the MDR. Furthermore, they must ensure that the information supplied by the manufacturer is provided in the official language(s) determined by the Member State where the device is made available, as per Article 14(2) MDR for distributors and Article 13(2) MDR for importers.

#General Labelling Principles

All information on the label and in the instructions for use must be clear, legible, and indelible. This applies to both the device itself and its packaging. The information must be accurate and reflect the device's intended purpose and characteristics. Annex I, Chapter III, Section 23 of the MDR details the information to be supplied with the device. This includes information on the label and, where applicable, on the packaging and in the instructions for use.

#Mandatory Label Elements

The MDR specifies a comprehensive list of information that must appear on the device label or its sterile packaging. This ensures clear identification and provides essential safety information. These requirements are primarily outlined in Annex I, Chapter III, Section 23.2 of the MDR.

#Identification and Manufacturer Information

• Name or trade name of the device: Article 23.2(a) MDR requires clear identification of the device. This must be the legal name under which the device is placed on the market.
• Manufacturer details: The label must include the name and registered place of business of the manufacturer (Article 23.2(b) MDR). This allows for direct contact and traceability.
• Authorised Representative: Where the manufacturer is not established in the Union, the name and registered place of business of the authorised representative must be indicated (Article 23.2(c) MDR). This is crucial for regulatory oversight within the EU. Further details on this role can be found in our article: EU REP vs EC REP Symbol: Why the Old Symbol Signals Outdated Documentation.

#Device Specifics

• Lot number/Batch code or serial number: Article 23.2(d) MDR mandates a lot number, batch code, or serial number. This enables traceability of individual devices or batches, essential for post-market surveillance.
• UDI carrier: The label must include the UDI carrier (AIDC and HRI) as referred to in Article 27 MDR. The Unique Device Identification (UDI) system is a global standard for device identification and traceability. The UDI system is detailed in Article 27 MDR and further specified by Commission Implementing Regulation (EU) 2021/2226.
• Date of manufacture and, if applicable, expiry date: Article 23.2(e) MDR requires the date of manufacture and, where relevant, the expiry date. These dates are crucial for product shelf-life management and patient safety.
• Storage conditions: Any particular storage or handling conditions must be indicated (Article 23.2(f) MDR).
• Sterility details: If the device is supplied sterile, the label must indicate this status and the sterilisation method (Article 23.2(g) MDR).
• Single-use devices: Devices intended for single use must be clearly marked (Article 23.2(h) MDR). This symbol prevents reprocessing, which could compromise patient safety.
• Medical device status: An indication that the product is a medical device, and the intended purpose, must be present (Article 23.2(i) MDR).

#Other Important Information

• Warning or precaution: Any specific warning or precaution to be taken must be indicated (Article 23.2(j) MDR).
• Latex presence: If the device incorporates or contains a substance of human or animal origin, or a derivative thereof, this must be stated (Article 23.2(k) MDR). The presence of natural rubber latex, which can cause allergic reactions, must be indicated.
• CMR substances or endocrine disruptors: Article 23.2(l) MDR requires an indication if the device contains certain hazardous substances above 0.1% weight by weight.

#EUDAMED and Traceability

The UDI system plays a central role in device traceability and is intrinsically linked to EUDAMED. While the full functionality of EUDAMED is being rolled out in stages, manufacturers are responsible for registering their devices and obtaining UDIs. Distributors and importers must ensure the UDI is correctly applied to labels. The current status and scope of EUDAMED modules should be confirmed with your national competent authority.

#Example of Labelling Information Requirements

#Language Requirements

Article 14(2) MDR and Article 13(2) MDR specify that distributors and importers must ensure that the device is accompanied by the information required by Article 10(11) MDR in an official Union language determined by the Member State where the device is made available to the user or patient. This often means providing labels and instructions for use in multiple languages, depending on the target market. Compliance officers must consult national competent authority guidance for specific language mandates.

#Common mistakes in practice

• Missing or incorrect UDI carrier: Failure to include the full UDI-DI and UDI-PI in both AIDC and HRI formats on the label, or incorrect UDI data submission to EUDAMED.
• Incomplete manufacturer or authorised representative details: Omitting full address, contact information, or the name of the authorised representative.
• Inadequate language translations: Not providing labels or instructions for use in the required official language(s) of the Member State of distribution, as mandated by national law.
• Absence of key safety symbols: Failing to use mandatory ISO symbols for sterility, single-use, or 'consult instructions for use'.
• Obscure or illegible information: Text that is too small, poor contrast, or easily smudged, making critical information difficult to read.
• Incorrect CE marking: Incorrect size, proportion, or placement of the CE marking, or associating it with non-MDR products.
• Outdated symbols: Using symbols that predate the MDR or are no longer harmonised standards. For instance, the older 'EC REP' symbol may indicate outdated documentation, as discussed in EU REP vs EC REP Symbol: Why the Old Symbol Signals Outdated Documentation.
• Lack of consistency: Discrepancies between information on the label, packaging, instructions for use, and EUDAMED registrations. Such inconsistencies can lead to issues with market surveillance, as our platform can highlight during UDI compliance checks.

#Conclusion

Accurate and complete medical device labelling is not merely a technicality. It is a cornerstone of patient safety and regulatory compliance. Distributors and importers play a vital role in verifying these elements before devices reach the market. Staying informed about the latest MDR requirements and national specificities is essential for maintaining market access and avoiding non-conformities.

This material is for information only and is not legal advice. For binding interpretation consult your national competent authority.