Technical documentation section 2. Information supplied with the device:

2.1 Information on the label

Label information

The label of a medical device must include the following details:

• Identification details: name or trade name of the device, clear identification of contents and intended purpose (if not obvious to the user).
• Manufacturer details: name, registered trade name/trademark, and address. If the manufacturer is outside the EU, the same applies for the authorised representative.
• Special contents: if the device contains a medicinal substance (including human blood/plasma), human or animal tissues/cells, these must be clearly indicated.
• Lot/serial number: clearly preceded by "LOT NUMBER" or "SERIAL NUMBER" (or equivalent symbol).
• UDI carrier: as specified in Article 27(4) and Annex VII, Part C.
• Date-related info: expiration date (in year and month format) or date of manufacture if no expiration is applicable.
• Storage & handling: any specific conditions must be mentioned.
• Sterility: if supplied sterile, include a statement of sterility and sterilisation method.
• Warnings: key precautions must be shown; further detail may be provided in the instructions for use.
• Single-use/reprocessed: indication of single use or, if reprocessed, how many times and any limitations.
• Custom-made or investigational: marked as ‘custom-made device’ or ‘exclusively for clinical investigation’, as applicable.
• Regulatory status: clearly state that the product is a medical device.
• Composition info: for absorbable or body-introduced substances, indicate qualitative and quantitative composition.
• Implantables: include serial number (for active implants), or serial/lot number for others.

Sterile packaging information

Packaging that maintains sterility must include:

• Recognition as sterile packaging
• Statement confirming sterile condition and method of sterilisation
• Manufacturer’s name and address
• Description of the device
• For investigational or custom-made devices, appropriate labels
• Date of manufacture (month and year)
• Expiration or safe-use date (year and month)
• Instruction to consult IFU if packaging is damaged or opened before use