Accurate labelling of medical devices is vital for the safe and proper use of medical devices by patients and care givers and is a key thing to get right when bringing a product to market. ISO 13485 considers medical device labelling includes the label, instructions for use, and any other information that is related to identification, technical description, intended purpose and proper use of the medical device.
Accordingly, when designing and evaluating the medical device labelling, manufacturers need to make sure they consider and include the following 10 key pieces of information:
- The name or trade name of the device.
- The name, registered trade name or registered trademark of the manufacturer and the address of its registered place of business.
- An indication that the device is a medical device.
- The details strictly necessary to identify the device and the contents of the packaging especially for the users, if the contents are not readily apparent, an indication of what the package contains, expressed in terms appropriate to the device, such as the size, net weight, length, volume or number of units.
- Unless self-evident to the intended user, the medical conditions, purposes and uses, as well as the performance specifications of the device if those specifications are necessary for proper use.
- Any special operating instructions
- Where there is no indication of the date until when it may be used safely, the date of manufacture. This date of manufacture may be included as part of the lot number or serial number, provided the date is clearly identifiable.
- The Unique Device Identifier.
- Warnings or precautions to be taken that need to be brought to the immediate attention of the user of the device, and to any other person. This information may be kept to a minimum in which case more detailed information shall appear in the instructions for use, considering the intended users.
- The quantity of contents.
The information that you need to include on your medical device labels is determined by which market or markets you are going to sell your product in. Label requirements can vary according to country and region, and the ISO15223-1 Medical devices — Symbols to be used with information to be supplied by the manufacturer is a harmonised reference standard. Within the UK and EU, medical device labelling must comply with the ISO 15223-1 standard, and label information must be presented in the language of the market. Labelling requirements for the US are set out in the FDA’s quality system regulations subpart K 21 CFR Part 820.120.
In the UK registration of your devices with the MHRA does not represent any form of accreditation, certification, approval or endorsement by the MHRA. Therefore, you are not permitted to make any claims to this effect, including the use of any MHRA logos in any marketing materials, on device packaging, in the instructions for use, on laboratory tickets/dockets, or in any other documentation (reference).
A simple procedure and checklist can be helpful to reduce the risk of errors in labelling design and packaging. An example process flow, and more detailed notes are available in our resource on labelling here.
