37Declaration of conformityUnitron Hearing declares under its sole responsibilitythat uDirect is in conformity with the followingstandards or other standardizing documents:Radio: EN 300-330EN 300 328EMC: EN 60601-1-2Safety: EN/IEC 60601-1Implementing the provisions of the MDD 93/42/EEC(Medical Device Directive), R&TTE Directive 1999/5/EC(Radio and Telecommunications Terminal Equipment),EMC Directive 2004/108/EC (ElectromagneticCompatibility) and LVD 2006/95/EC (Low VoltageDirective).