In which language(s) should the EU Declaration of Conformity be written?

A CE marking enables your medical device company to market and sell your product throughout the European Free Trade Area. Oct 31, 2019 ... The CE marking reflects the manufacturer's commitment to comply with European legislation and is mandatory for placing a product on the common ... As of 1 January 2022 the 30 months countdown started to August 2024 when cyber security will formally be a mandatory requirement for CE marking of radio ... Jun 10, 2024 ... CE marking is a manufacturer's declaration that a product meets the requirements of the applicable European Community directives. Smart CE marking.. Smart CE marking is the link between the physical product and the Declaration of Performance (DoP). It is the access to this extensive ... Apr 26, 2023 ... CE is an abbreviation of the French “Conformité Européenne”, which means “European Conformity”. Countries within the European Economic Area (EEA) ... GUILFORD, CT – February 21, 2023 — Hyperfine, Inc. (Nasdaq: HYPR), the groundbreaking medical device company that created the Swoop® system, the world's ... 10 Steps to CE Marking. Step 1: Identify the Directive/s that is/are applicable to your product. You can download these directives free of charge from the EU ... Many products are covered by these directives and, to be placed on the European market, must bear the 'CE' mark - it's a legal requirement. CE marking is the ... We are regulatory professionals who guide on specific requirements that must be met and obtain the medical device CE Marking.