Under the IVDR (2017/746) manufacturers will need to state on their labels when the device is intended for self-testing or for near-patient testing, and for certain rapid tests when they are not intended for self-testing nor for near-patient testing.
MedTech Europe (MTE) wants to make this more effective by providing industry with agreed symbols for these device aspects. To that end, MTE has announced the launch of a new webpage which will include: