What are the implications of artificial intelligence for conformity assessment procedures?

CE marking is a self-declaration where a manufacturer proves compliance with EU health, safety and environmental protection legislation and confirms a product's ... 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, ... 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. The Construction Products Regulation (CPR) is fully implemented from 1st July 2013 across the 27 European Member states. As a result, all construction products ... Mar 2, 2021 ... The FDA approval and CE-marking of Guardant360 CDx for tumor mutation profiling and as a companion diagnostic for Tagrisso (osimertinib) ... 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. CE marking mandatory for more than 20 product groups. CE marking is mandatory for more than 20 product groups, including construction products, gas appliances, ... Oct 5, 2015 ... The application of CE mark enables Novocure to distribute the second generation Optune system in the European Union and Switzerland. Novocure ... Nov 1, 2014 ... The added value of CE marking is that all EU countries must allow the selling of construction products bearing the CE mark. This means that ... A mark required for many products that must be assessed, before being placed on the market, to meet EU safety, health and environmental protection ...