EU General Product Safety Directive published:
This article was originally published in Clinica
Executive Summary
The text of the amended European Union's General Product Safety Directive (2001/95/EC) was published in the Official Journal of the European Communities on January 15 2001. This significantly updates the 1992 version of the Directive. Member state laws implementing it must take effect from January 15 2004. These will impact medical devices that are used by the consumers and sold over the counter and may also impact devices sold to hospitals, although clarification is still needed on this point (see Clinica No 986, p 5).