As a result of European unification, new regulations valid within the
territory of the European Union (EU) have been negotiated and publishe
d. As in other medical fields, the Medical Device Directive (MDD) is t
he most important new regulation and also effects endoscopy, In a tran
sition period until June 1998, the MDD will be transposed into nationa
l law by the member states of the EU, Compliance with the MDD and othe
r European regulations is indicated by the CE mark affixed to the prod
uct.