By 26 May 2022, IVD devices will transition to the new IVD Regulation EU 2017/746. This regulation will require devices intended for self-testing, devices intended for near-patient testing and certain rapid tests (not for self-testing and not for near patient testing) to state these facts on their labels.
The use of symbols on the label is an effective way of compliance and it is permitted by the IVDR. By including these symbols proposed by MedTech Europe, the intended user of your device will be clear. It will also remove the necessity to translate that indication into all EU languages.
The document can be downloaded in our library
Source: MedTech Europe