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Medical Device Directive MDD93/42/EEC

The Medical Device Directive was published in 1993 by the European Commission. Medical device manufacturers were able to apply the Medical Device Directive on January 1, 1995. At that time, the manufacturers had the choice to apply either national regulation or the Medical Device Directive. In June 1998, the Directive became mandatory and medical devices, which fell under the scope of the Medical Device Directive, were no longer allowed without the CE mark on the European market. At that time, the European market consisted of 15 member states and countries of the European Economy Area (EEA). Today the EU has 25 member states and forms together with the EEA countries one single market, made up of 29 states.

The Medical Device Directive was corrected and amended over the time. There were only minor corrections, but some significant amendments. The amendments are being done either by including those into other directives, for example in the In-Vitro-Diagnostic Medical Device Directive, or by means of a separate document which covers a specific aspect, for example, the Directive 2000/70/EC of the European Parliament and the Council of November 16, 2000, amending Council Directive 93/42/EEC as regards medical devices incorporating stable derivatives of human blood or human plasma.

Below is the original document as well as a consolidated version of the Directive, including all the amendments. The following link to the European Commission “EURLex” shows the corrections and amendments. http://europa.eu.int/smartapi/cgi/sga_doc?smartapi!celexapi!prod!CELEXnumdoc&lg=en&model=guicheti&numdoc=31993L0042

The five-year review of the Medical Device Directive which is required by the Medical Device Directive itself is almost completed. We assume that a complete new text will be issued by the European Commission in the near future. There will be a transition period, but it is expected that this period will not be as long as the initial transition period of five years when the Directive was first published.

Please choose from the following selection of download options:

(Right click on the links below to download to your computer - select 'save target as')

1. MDD 93/42/ EEC zip file in word 6.0/word 97 format 
    

2. MDD 93/42/ EEC zip file in RTF (Rich Text Format) 
    

3. MDD 93/42/EEC Consolidated Text

(Status: September 7, 2005)

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