Medical device labeling requirements
There isn’t a one-size-fits-all format for a great medical device label. The required elements will vary depending on many factors. It’s up to the manufacturer to ensure that all of the necessary elements are included, and that the label succeeds in conveying the information needed by the patient to have a positive and beneficial experience using the device.
Labeling Content
The label of a medical device must include essential information such as the device's intended purpose, instructions for use, contraindications, manufacturer's details, and any precautions or warnings. The information should be clear, understandable, and in the official language(s) of the member state where the device is made available.
UDI on the Label
The UDI must be placed on the label of the medical device. The UDI serves as a key to access information about the device in the European Database on Medical Devices (EUDAMED).
Symbols and Abbreviations
If symbols are used on the label, they should comply with the relevant standards (ISO 15223), and the label should include an explanation of the symbols. Abbreviations should be easily understandable.
Readability and Legibility
Labels must be easily readable and legible to the intended user. The font size and other specifications should be appropriate for the device.
Labeling of Single-Use Devices
For single-use devices, the label must indicate that the device is intended for single use.
Date of Manufacture and Expiry Date
The label should include the date of manufacture and the expiry date if applicable.
To sum up the medical device labeling requirements, manufacturers should ensure that their product labels bear all the following elements to avoid non-compliance:
- Product name
- Product’s lot number or serial number
- All details needed for a user to identify the device, the contents of its packaging and the intended purpose of the device
- Contact details of the manufacturer (e.g., name and address)
- In the case of non-EU based manufacturers, the name and address of their authorised representative
- Where relevant, information per Section 10.4.5. of the MDR
- The UDI carrier referred to in Part C of Annex VII of the MDR
- An indication of any special storage or handling conditions
- A clear indication of the time limit for using the device safely, or where this is not applicable – the date of manufacture
- If the product is supplied in a sterile condition, an indication of its sterile state and method of sterilisation
- An indication if the product is for single-use
- An indication if the device is custom-made or intended for clinical investigation only
- Other warnings and precautions to be taken that need to be brought to the user’s immediate attention
Unique Device Identification (UDI) Requirements
Medical devices placed on the EU market must bear a UDI. The UDI system consists of a UDI-DI (Device Identifier) and, if applicable, a UDI-PI (Production Identifier).
The UDI-DI is a unique numeric or alphanumeric code that identifies the specific model or version of a device. It is assigned by the manufacturer.
The UDI-PI provides information on the production history of a device, including the lot or batch number, serial number, expiration date, and manufacturing date.
The UDI must be placed on the label of the device and, if applicable, on the packaging. For certain devices, it may also need to be on the device itself.
The UDI should be presented in a way that is easily readable or, where appropriate, accessible to the user and the patient. The UDI carrier (barcode or other form) must comply with international standards.
Manufacturers are required to submit UDI information to EUDAMED, the European Database on Medical Devices. EUDAMED serves as a central repository for information on medical devices placed on the EU market. Within the EU, the manufacturer shall assign to their devices, together with a UDI, also a Basic UDI-DI, which is not yet required by other jurisdictions. The Basic UDI-DI is the main key in Eudamed and relevant documentation (e.g. certificates, declaration of conformity, technical documentation and summary of safety and clinical performance) and will also be the access key for device-related information entered in the database.
