Products manufactured in accordance with harmonised standards shall enjoy a presumption of conformity with the relevant essential requirements of the directives in the area covered by the standard. Demonstration of conformity with harmonised standards shall be the recommended and most accessible form of demonstration of conformity with the essential requirements of the Directive.
Although compliance with the requirements of harmonised standards is not mandatory, failure to comply with them may raise doubts as to the design of the medical device based on the latest state of the art and cause increased risks associated with the use of the device.