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Medical Device Labelling Requirements

Updated: Aug 9, 2022

A label represents the written, printed or graphic information appearing either on the medical device itself, or on the packaging of each unit or the packaging of multiple medical devices. Manufacturers must 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 authorized 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 sterilization

  • 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

Download a copy of BSI instructions for labelling here:

bsi-md-symbols-and-information-to-be-provided-by-the-manufacturer-webinar (1)
.pdf
Download PDF • 923KB

Label example

Also, please be aware there are other symbols to use in case of CMR/Endocrine-Disrupting Substances/Blood and Tissue, reprocessing cycles.



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