Use of Standards to Establish Conformity

Although the directives allow flexibility in the methods and solutions that a manufacturer may employ to fulfil the essential requirements, they promote the use of standards as the preferred method to establish conformity. Specifically, the directives stipulate that Member States shall presume compliance with the essential requirements in respect of devices that are in conformity with relevant harmonised standards. 

Standards may be developed at global level through the International Standards Organisation (ISO) or the equivalent International Electrotechnical Commission (lEC) for electrical equipment. These contain representatives from standards bodies 

The devices must be designed and manufactured in such a way that when used as intended they do not compromise the safety of patients or users. Any risks that may be associated with their use must be acceptabie when weighed against the benefits to the patient and be compatible with a high level of protection of health and safety. 

The devices must be designed and manufactured in such a way that they will deliver their intended performance under the recommended condition for use. 

The design and construction of devices must adhere to safety principles by applying the following measures in the following order  

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