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.
PD CEN/TR 12401:2009 history
2009PD CEN/TR 12401:2009 Dentistry - Guidance on the classification of dental devices and accessories
2003PD CEN/TR 12401:2003 Dentistry Guidance on the classification of dental devices and accessories Supersedes CR 12401:1996