Introduction to the medical device directive (MDD93/42/EC)

The medical device directive comes from the European regulations and was introduced in 1993. The directive specifies which steps need to be taken before a medical device can be brought to the European market. Compliance with the directive can be seen on the CE logo on the product packaging, whether or not with a notified body number. The directive consists of a number of articles and a series of annexes.
 
The full text of the MDD can be downloaded here.
 
The main points from the MDD are:
Subject Part of MDD
Safety Annex I, Article 3
Definition of a medical device         Article 1 (intended use)
Accessory Article 1
Responsible persons Article 14
Classification Annex IX, Article 9
Conformity Assessment Artikel 11, Bijlage II-VII
Labelling Annex I, Article 13
Information about incidents Annex II, Article 10
Clinical investigation Annex X, Item 15
CE-mark Annex XII
Design Dossier Annex II