Medical Device Labelling: A label is the written, printed, or visual information that appears on the medical device itself, as well as the packaging of individual units or numerous medical devices. To avoid non-compliance, manufacturers must ensure that their product labels include all of the following elements:

  • Name of the device
  • The serial number or lot number of a device
  • All information required for a user to identify the item, including the contents of its package and the gadget’s intended function
  • Manufacturer’s contact information (e.g., name and address)
  • The name and address of their approved representative in the event of non-EU manufacturers
  • Where applicable, information in accordance with MDR Section 10.4.5
  • Part C of Annex VII of the MDR refers to the UDI carrier
  • Any specific storage or handling criteria are indicated
  • A clear statement of the time limit for safely operating the item, or the date of manufacture if this is not relevant
  • If the product is sterile, the state of sterility and the technique of sterilization must be specified
  • If the product is intended for one-time use, this will be indicated
  • If the equipment is custom-made or solely for clinical research, this is indicated
  • Other dangers and warnings that need to be brought to the user’s notice right away

EU MDR Requirements for Product Labelling as per below harmonized standard must be followed by all manufacturers.

EN ISO 15223-1:2016 Medical devices – Symbols to be used with medical device labels, labelling and information to be supplied – Part 1: General requirements (ISO 15223-1:2016, Corrected version 2017-03)

Medical device manufacturers must meet a number of standards in terms of the information they provide with their products. Each medical equipment, for example, must have the information needed to identify the item and its maker, as well as any pertinent safety and performance information for the user. This information might be found on the product’s surface or on its box.

(Related – User Manual Requirements for Medical Devices )