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)
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Identify the essential requirements and justification for their use
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Advise on methods used to demonstrate conformity with each Essential Principle that applies
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Advise on standards to be used
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