The Bible in EU - Medical Device Directive

The Medical Device Directive (Council Directive 93/42/EEC of 14 June 1993) is intended to harmonise the laws relating to medical devices within the European Union. In conformity with MDD 93/42/EEC enables a manufacturer to legally place a medical device on the European market. Medical devices conforming with MDD 93/42/EEC must have a CE mark applied. The Directive was most recently reviewed and amended by MDD 2007/47/EC and a number of changes were made, which compliance was implemented on March 21, 2010.

A copy of MDD 93/42/EEC can be download here for reference.

(Click to download)