What are the future trends in CE marking?

The review concludes that FDA- and TGA-approved indications match the available clinical data, whereas CE marking indications can have discrepancies. 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 ... The CE mark is a mandatory European marking for machinery and equipment to indicate conformity with the essential health and safety requirements set out in ... Mar 2, 2021 ... The FDA approval and CE-marking of Guardant360 CDx for tumor mutation profiling and as a companion diagnostic for Tagrisso (osimertinib) ... The letters "CE" are the abbreviation of French phrase "Conformité Européene" which literally means "European Conformity". The term initially used was "EC Mark" ... CE marking is required for all in vitro diagnostic (IVD) devices sold in Europe. CE marking indicates that an IVD device complies with the European In-Vitro ... Jan 25, 2021 ... The way in which a manufacturer must CE mark its device depends on the type of device in question and the regulations (MDR or IVDR) that apply. Jul 25, 2022 ... The ubiquitous emblem of the CE mark effectively determines which goods in key product categories can be legally sold within the European Economic Area. A new conformity mark has been introduced in Great Britain (England, Wales and Scotland) to replace the CE mark; this is the UKCA mark. CE marking is a mark that manufacturers use to indicate that a product meets relevant European Union (EU) legal conformity standards in terms of safety, health ...