EU-MDR introduces the requirement to add additional information on labels, therefore, mandates the re-design of label templates in order to incorporate the extra info
as well as the revised and/or new symbols introduced by the ISO-15223, which is currently under development.
GSPRs 23 outlines the contents of a MDR-compliant and corresponding IFUs. Manufacturers must ensure that their product labels include all the following elements in order 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
Read more here: MDR Labels in EU-MDR
