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) |
| Accessory | Article 1 |
| 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 |
| CE-mark | Annex XII |
| Design Dossier | Annex II |