Introduction to the medical device directive (MDD93/42/EC)
The medical device directive comes from 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)|
|Responsible persons||Article 14|
|Classification||Annex IX, Article 9|
|Conformity Assessment||Artikel 11, Bijlage II-VII|
|Labeling||Annex I, Article 13|
|Information about incidents||Annex II, Article 10|
|Clinical investigation||Annex X, Item 15|
|Design Dossier||Annex II|