MedTech Europe has prepared a guidance document in response to the new requirements in the Medical Devices Regulation (MDR) that ask for various kinds of information to be indicated on the label of medical devices.
The guidance contains symbols to address the following information requirements:
- Medical device
- Contains human blood or plasma derivatives
- Contains a medicinal substance
- Contains hazardous substances
- Contains biological material of human origin
- Contains biological material of animal origin
- Sterilized using vaporized hydrogen peroxide
- Translation
- Repackaging
- Single Patient Multiple use
The guidance also contains recommended symbols to be used with patient implant cards.
What does this mean to you?
This guidance document is intended for informational purposes only and should not be construed as legal advice for any particular facts or circumstances.
The symbols in this guidance have been validated by MedTech Europe in accordance with the ISO 15223-2 process and have been proposed to ISO TC 210 WG 3 for the ISO 15223-1 revision.
You can start using these symbols on your labelling but they must be described in your IFUs until they are published in a harmonised standard.
Should you want to discuss this more in depth with one of our consultants, please do not hesitate to get in touch with us.
