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Market are governed by one (or sometimes more) New Approach Directive.The manufacturer thus bears sole responsibility for introducing a product thatcomplies with all the requirements of the relevant Directives. He must also makesure that he follows any Conformity Assessment procedures when required,including the Technical File, the CE Marking and the Declaration of Conformity.A manufacturer may be established inside or outside the European Union; butin all cases the product must comply with the applicable European legislationif it is to be or has been introduced in the European Union. Whether inside oroutside the European territory, to make things easier the manufacturer may appointan Authorized Representative (in this case it must be located within the EuropeanUnion) to act on his behalf.It is also useful for manufacturers to know that European legislation is quite stricton “upgraded products” and treats most modifications or new functions addedas if they were new products, and as such they are held to the same certificationrequirements as any other new product.Just as a reminder, it should not be forgotten that complying with the law is alwaysmandatory and that only products complying with those essential requirementsmay be placed on the European market.The Technical FileThe advantage of New Approach Directives is that they include, for many products,the opportunity for manufacturers to directly declare conformity to the essentialrequirements. But this right to declare compliance with the European legislationmeans that the manufacturer is the only one responsible for completing andupdating all the procedures required by the legislation.For all products covered by the New Approach Directives the manufacturer hasto declare compliance with the essential health and safety requirements. For someproducts the New Approach Directives also require the intervention of a NotifiedBody (depending on the level of risk of the product). Whether or not the interventionof an independent third party is required (Notified Body), the manufacturer mustalways prepare a Technical File.The Technical File is the written justification that all parts and functions of theproduct are safe (thus complying with the essential health and safety requirementsset by the New Approach Directive) and can therefore be placed on the EuropeanMarket. The Technical File includes the information that proves the technical basis44 CENELEC. <strong>Primer</strong> on Standards