Manufacturers of devices without an intended medical purpose
The new MDR covers some devices without an intended medical purpose. These are similar to medical devices in functioning and risk-profile.
Annex XVI of the Regulation contains the list of the group of devices concerned.
The Commission will adopt common specifications for risk management and, where necessary, clinical evaluation regarding safety.
If a device has a medical and non-medical purpose, it should fulfil the requirements for devices with, as well as without an intended medical purpose.