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Definition: CE marking is a certification mark that indicates a product’s compliance with essential health and safety requirements set forth by EU directives. It signifies that your product meets the necessary standards for market access.
CE marking certifies compliance with rigorous health and safety requirements mandated by EU legislation. In this article, we explore why CE marking is necessary for medical devices and the key steps to obtain this certification.
3 lip 2024 · CE marking indicates that a product has been assessed by the manufacturer and deemed to meet EU safety, health and environmental protection requirements. It is required for products manufactured anywhere in the world that are then marketed in the EU.
22 gru 2022 · Learn everything about CE marking for medical devices, including what it is, its importance, the process steps, and how a medical device eQMS can help.
An overview of the CE marking process for medical device manufacturers in the European Union, and the associated technical documentation/general safety and performance requirements (GSPRs) that manufacturers are required to maintain.
19 cze 2024 · The CE Mark, an abbreviation for "Conformité Européenne" or "European Conformity," is a regulatory mark and a key passport for products to circulate freely within the EEA. This mark indicates that a product meets the EU's stringent safety, health, and environmental protection standards.
28 paź 2024 · The CE marking indicates that a product is compliant with the requirements of relevant CE marking directives and regulations. Such directives and regulations apply to a wide range of products, including electronics, toys, helmets, sunglasses, and medical devices.
