Pulse Oximetry FAQ

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What does the CE marking mean?

The CE marking is a mark that manufacturers must obtain in order for their devices or products to be sold within the European Union (EU). Each company has a notified body that is paid by the company to ensure ISO compliance. The company must demonstrate to the notified body that the device meets the ISO standard. This marking signifies that the product is in compliance with European health, safety, and environmental protection standards. The CE marking may also be found on products sold outside of the EU that have been manufactured to these standards.

The CE marking is required for medical devices, and having it confirms that the device meets essential requirements of the European General Medical Devices Directive and that it is safe. Of note, the CE marking is not a quality indicator or a certification mark, but it does indicate that the device complies with EU regulations and can legally be sold.

Additionally, falsification of CE marking is commonly encountered.

 

References: European Commission CE Marking

Keywords: CE, marking, european general medical devices directive, EEA

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