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Many products require CE marking before they can be sold in the EEA (European Economic Area comprises the 28 EU Member States and EEA EFTA Countries - Iceland, Lichtenstein and Norway).CE marking proves that your product has been assessed and meets EU safety, health and environmental protection requirements.
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How to obtain European CE marking for your medical device. CE is not a quality mark, but compliance with EU Directives requires you to meet specific standards of performance, quality, safety, and efficacy for your product type. We have a detailed chart explaining the current European CE approval process for medical devices here. However, the ...
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CE marking is a certification mark that indicates conformity with health, safety, and environmental protection standards for products sold within the European Economic Area (EEA). The CE marking is also found on products sold outside the EEA that are manufactured in, or designed to be sold in, the EEA. This makes the CE marking recognizable worldwide even to people who are not familiar with ...
"CE Marking" is now used in all EU official documents. "CE Mark" is also in use, but it is NOT the official term. For instance, in the Directive 2007/47/ec, of 5 September 2007, amending the directives 90/385/eec, 93/42/eec & 98/8/ec, the term CE Marking appears 9 times whereas CE Mark appears nowhere in the entire 35-page document.
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Get Clear Directions Fast. Stop wasting your valuable time. Get clear answers from the experts. Learn more about how we can help to determine what CE requirements apply to your products and how you can do the CE marking yourself using our tools to reduce the costs.
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