Directive 2014/53/EU clause (40) cites decision 768/2008/EC to include conformity assessment procedures associated with the level of risk for meeting the essential requirements. Module B clause 3. (c) calls for inclusion of risk analysis as part of the notified body (NB) application. In cases where the use of harmonized standards support self-declaration, the file should contain the same risk analysis to confirm that risks have been identified and risk resolution is attained by application of the harmonized standard. If a risk is identified that is not addressed by application of the harmonized standard, the risk resolution is documented as part of the file for NB approval.
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