CE Marking
With our guidance it is quite possible for even a novice to compile a file which will meet the self certification requirements and allow the creation of an "EU declaration of conformity" certifying your product accordingly. For clients prepared to get involved, this is a very economical path to CE mark certification. Alternatively, for clients who want the minimum of administrative commitment to CE marking, we offer a complete turnkey service. We advise and guide on any of the many facets of CE marking from the contents of the technical file to approvals testing such as EMC and safety testing under EN60601. Let us help you cut through the jargon and bureaucracy and get your product to market. Contact us for help meeting CE approvals. About CE marking CE marking is an EU creation intended to assist with market harmonisation and enhance the free movement of goods within the EU. A CE mark confirms that the product has been assessed by the manufacturer before it is put on the market and meets EU health, safety, and environmental protection requirements. Around 20 EU directives set out the product categories requiring EU markings and the general harmonised requirements to be met. Related European standards set out the relevant technical details. It is the manufacturer's responsibility to ensure that a product conforms to EU directives and standards and has been risk assessed. A product has a "presumption of conformity" when it fully complies with the standards. The manufacturer must draw up an "EU declaration of conformity" certifying the product accordingly. EU Directives may specify that authorised national organisations must be involved in the conformity assessment. The manufacturer must write a technical file demonstrating conformity and assessment of risks. This, in addition to an EU declaration of conformity must be made available on request. The CE marking itself must be placed visibly on the product. In addition, when required, the identification number of the national organisation (notified body) who assessed the product must be shown as well.
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