Apr 27, 2015

Although major news regarding new European medical device regulations remains forthcoming, European Commissioners have recently rolled out a new directive for devices using wireless components and reorganized their website so that manufacturers can more easily research laws and regulations beyond the Medical Device Directives that may also require compliance.

First, legislation covering medical devices that use radio or wireless components has been revised; the new legislation, Directive 2014/53/EC, goes into effect June 13, 2016, and will replace Directive 1995/5/EC on that date.

Second, the EU Commission website has been updated so that other regulations and policies besides Medical Device Directives can be easily found and researched. This change should prove valuable for medical device manufacturers that must comply with additional European requirements beyond CE Mark certification, such as environmental and chemical legislation, energy legislation, directives on human tissues and cells, and the European Machinery Directive.  


  • Stewart Eisenhart