Are there specific CE marking requirements for artificial intelligence (AI) products?

A manufacturer in the EU can utilize applicable European harmonised standards and/or Directives to in order to affix CE marking. In the United States, ... Mar 13, 2025 ... Electronic products sold in the EU must have a CE Mark. Learn about the CE Mark requirements and compliance standards required for ... CE marking is a self-declaration where a manufacturer proves compliance with EU health, safety and environmental protection legislation and confirms a product's ... Nov 3, 2024 ... The CE marking under the European Accessibility Act (EAA) confirms that a product meets EU standards for accessibility, in addition to safety, ... The CE marking shall be affixed before the product with digital elements is placed on the market. It may be followed by a pictogram or any other mark indicating ... Directive 2014/68/EU defines the safety requirements for pressure equipment throughout the EU and the European Economic Area. GUILFORD, CT – February 21, 2023 — Hyperfine, Inc. (Nasdaq: HYPR), the groundbreaking medical device company that created the Swoop® system, the world's ... Transparency and Safety on European Markets. CE Marking. Only safe, flawless, and quality goods should be available on the European market – at least, that's ... Feb 23, 2021 ... The CE-marking is a clear indicator of a product's compliance with EU legislation. It is thus not an indication the product was produced in the EEA or Turkey. Oct 5, 2015 ... The application of CE mark enables Novocure to distribute the second generation Optune system in the European Union and Switzerland. Novocure ...