Legislation

Current legislation

Medical Devices are regulated by three main Directives:

 

Active implantable medical devices

In vitro diagnostic medical devices

(Other) Medical devices

Original directive

Directive 90/385

Directive 98/79pdf [347 KB]

Directive 93/42

Amendment 1

Directive 93/42

Regulation 1882/2003pdf

Directive 98/79pdf [347 KB]

Amendment 2

Directive 93/68

Regulation 596/2009pdf

Directive 2000/70pdf

Amendment 3

Regulation 1882/2003pdf [218 KB]

 

Directive 2001/104pdf

Amendment 4

Directive 2007/47pdf

 

Regulation 1882/2003pdf [218 KB]

Amendment 5

  

Directive 2007/47pdf [185 KB]

Latest but one consolidated version

20.11.2003pdf including amendment No. 3

20.11.2003pdf [188 KB] including amendment No. 1

20.11.2003pdf including amendment No. 4

Latest consolidated version

11.10.2007pdf [158 KB] including amendment No. 4

07.08.2009pdf [210 KB] including amendment No. 2

11.10.2007pdf [265 KB] including amendment No. 5

You can find more detailed information about the medical devices legal framework on these following pages: