Document paper New medtech regulations

Medical Devices Regulation (MDR): New symbols for medical devices – Factsheet for healthcare professionals

The aim of this factsheet is to assist healthcare professionals (HCPs) – users of medical devices – in getting familiar with new symbols created in relation to the Medical Devices Regulation (EU) 2017/745 (‘MDR’).

The MDR has new requirements that ask for various kinds of information to be indicated on the label of the medical device.

There are 24 official languages in the EU, which creates a necessity to translate the information on labels, instructions for use, manuals, leaflets etc. depending on where the device is sold. Inclusion of internationally recognised and harmonised symbols instead of text is an efficient and valid way of providing the user with the information which is required by the MDR.

Symbols are a tool for conveying the required information and their use is encouraged by the MDR. It is the information itself which is required to be on the device and symbols are one way of conveying that information.

See the factsheet below.

Posted on 03.06.2024

Related content