What is the meaning of presumption of conformity? 

A presumption of conformity means that you are deemed to meet the Essential Requirements of the CE marking Directives. You can benefit from a presumption of conformity by testing to European Harmonised Standards which are published in the Official Journal of the European Union. You can view a list of the 21 Directives and their associated Official Entry listings from the website of the European Commission: http://ec.europa.eu/enterprise/policies/european-standards/documents/harmonised-standards-legislation/list-references/index_en.htm

You do not have to test to European Harmonised standards but then you lose the benefit of the presumption of conformity and have to explain your compliance rationale in the technical file.

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