Commission Directive (2005/50/EC of 11 August 2005) reclassifying hip, knee and shoulder joint replacements comes into force in the Member States on 1 September 2007. This directive raises the classification of these devices from Class IIb (medium risk) to class III (high risk) .
New guidance line MEDDEV "Vigilance"
In April a new vigilance guideline has been issued by the European commission: MEDDEV 2.12-1 rev 5,
will be effective per January 1st, 2008
