This CEN Technical Report provides guidance on the application of the classification rules in Council Directive 93/42 EEC of 14 June 1993, amended by Directive 2007/47/EC, concerning medical devices as they pertain to dental devices and accessories.
DS/CEN/TR 12401:2009 history
2009DS/CEN/TR 12401:2009 Dentistry - Guidance on the classification of dental devices and accessories