Essential requirements

The devices must meet the essential requirements which apply to them, taking into account the device’s intended purpose. Each technical file/design dossier should contain a list of essential requirements. This is usually presented in the form of a checklist.

The checklist should identify:

• the Essential Principles
• whether each Essential Principle applies to the device and if not, why not
• the method(s) used to demonstrate conformity with each Essential Principle that applies
• a reference for the method(s) employed (e.g., standards), and
• the precise identity of the controlled document(s) that offers evidence of conformity with each method used

Methods used to demonstrate conformity may include one or more of the following:

• conformity with recognised or other standards
• conformity with a commonly accepted industry test method(s)
• conformity with an in-house test method(s)
• the evaluation of pre-clinical and clinical evidence
• comparison to a similar device already available on the market (GHTF/SG1/N011:2008)