The CE mark must be applied to all applicable products being sold into the EU.
The CE mark indicates conformity with various health, safety and protection standards when applied to all products sold into the European Economic Area (EEA). The CE mark must be applied to all applicable products being sold, whether they were originally manufactured in the European Union or not. The CE mark is recognized worldwide, but typically only required for sale into the EEA. By applying a CE mark to a product, the manufacturer is making the claim that their product has been tested to and is compliant with the requirements of the applicable EC Directives.
The CE mark is a manufacturer declaration, meaning that by applying the CE mark, the manufacturer is declaring at its sole responsibility that the product conforms with all the legal requirements necessary for CE compliance. In certain cases, if the product is considered to be higher risk, a Notified Body must be involved. By having an additional Notified Body review, the CE mark is given further legitimacy beyond just the manufacturer claiming responsibility for the compliance: The Notified Body provides a full review of all testing that has been done to the machine for compliance.
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