MDR-compliant Labels

Evnia news

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

TOP