Statement on nomenclatures used for regulatory purposes (such as registration) in the field of in vitro diagnostics

It is becoming the norm for many regulators to request a nomenclature code at the time of registration of the device.

Once a new IVD Regulation comes into force it will trigger a re-registration of all devices. Manufacturers will need to include nomenclature codes for their devices during this registration process.

With the implementation of Unique Device Identification (UDI) systems, the nomenclature which describes the device becomes key as an integral part of the UDI Database.