The Commission of the European Union (EU) has published an updated list of standards that can be used to demonstrate conformity with the essential requirements of its Directive 90/385/EEC, relating to active implantable medical devices.
According to the EU’s Directive, “an ‘active medical device’ means any medical device relying for its functioning on a source of electrical energy or any source of power other than that directly generated by the human body or gravity.”
Further, “an ‘active implantable medical device’ means any active medical device which is intended to be totally or partially introduced, surgically or medically, into the human body or by medical intervention into a natural orifice, and which is intended to remain after the procedure.”
The updated list of CEN and CENELEC standards that can be used to support compliance with the Directive was published in the Official Journal of the European Union in August 2011, and replaces all previously published standards lists for the Directive.
