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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 27 member states and forms together with the EEA countries and Switzerland one single market, made up of 31 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.

Please find the latest consolidated MDD93/42 EEC below, with the biggest change in 2007 which came into force in national legislation of the member states on March 21, 2010.

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

MDD 93/42/ EEC in PDF format

(Status: June 2011)
 


In Vitro Diagnostic Medical Device Directive 98/79/EC


The IVD Directive was published in 1998 by the European Comission. The directive´s content became mandatory to apply on June 7, 2000. The IVD Directive was amended and corrected over time. Please find the latest consolidated IVDD 98/79/EC below.

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

IVDD 98/79/EC in pdf format

(Status: Sep. 2012)



Active Implantable Medical Deivce Directive AIMDD 90/385/EEC

The Active Implantable Medical Device Directive (AIMDD) was published in 1990 by the European Commission. The diective´s content became applicable on January 1, 1993 with a transitional period until December 31, 1994. During this transitional period previous national regulations or the content of the new directive could be applied. The AIMDD Directive became corrected and amended over time. Please find the latest consolidated AIMDD 90/385/EEC below.

(Right click on the link below to download to your computer - select 'save target as')
AIMDD 90/385/EEC in pdf format

(Status: Sep. 2012)