In which language(s) should the technical file be kept?

Jun 13, 2016 ... The RoHS Directive 2011/65/EU, or 'RoHS2' as it is sometimes called, is a CE marking Directive and is a European law. What is CE marking? CE marking indicates the manufacturer's claim that a product meets the essential requirements of all relevant European directives and/or ... The letters "CE" are the abbreviation of French phrase "Conformité Européene" which literally means "European Conformity". The term initially used was "EC Mark" ... Mar 5, 2020 ... V-Wave Ltd., a privately held medical device company developing novel implantable devices for the treatment of Heart Failure (HF), today ... Apr 26, 2023 ... CE is an abbreviation of the French “Conformité Européenne”, which means “European Conformity”. Countries within the European Economic Area (EEA) ... Directive 2014/68/EU defines the safety requirements for pressure equipment throughout the EU and the European Economic Area. Nov 4, 2024 ... The CE mark consists of the letters 'CE', sometimes followed by the identification number of a notified body, as below. The identification ... Jan 14, 2023 ... Any new IVD placed on the EU market from 26 May 2022 must be developed, manufactured and maintained in accordance with this regulation to be CE marked. Manufacturers can place a CE (Conformité Européenne) mark on a medical device once it has passed a conformity assessment. The conformity assessment usually ... Feb 8, 2022 ... Devices in the Class IIa category are for short-term use (30 days or less), such as tubing intended for drug delivery, syringes, and surgical ...