About the CE marking

About the CE marking
November 17, 2021

About the CE marking

ARTICLE BY: Marjeta Tušek Jelenc
CATEGORY: Regulatory Compliance

We are sure you have noticed the letters "CE" on different products. But do you know what they mean and why they should appear? CE is the abbreviation of "conformité européenne" and it tells consumers that the product labeled with CE has been assessed and complies with the high safety, health, and environmental protection requirements of the EU. 

The letters CE appear on many products, such as toys, electrical appliances, machinery, measuring instruments, and also on medical devices, traded on the extended single market in the European Economic Area (EEA). Manufacturers have the responsibility to ensure that products placed on the extended single market of the EEA are safe. By affixing the CE marking to a product, we as a manufacturer declare that the product meets all the legal requirements for the CE marking and can be sold throughout the EEA. This applies to all products intended for sale in the EEA, whether they were manufactured in the EU or not.

All our IVD medical devices also have a CE mark, meaning that they are safe to be used by patients and doctors, perform as intended, and meet the required performance, quality, safety, and efficacy standards. In order to comply with these specific requirements, our devices undergo strict testing, verification, validation, and evaluation, and everything is carefully documented.

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