FDAnews Device Daily Bulletin

Manufacturers should consider all of a device’s characteristics when determining its classification in the EU, according to a new guidance. “The characteristic or combination of characteristics in accordance with the intended purpose of the device that rates the highest class determines the class for the device as a whole,” the European Commission (EC) says in its revised MEDDEV 2.4/1 guidance on device classification. The new version takes into account changes in the Medical Device Directives (MDD).
International Medical Device Regulatory Monitor