What is the role of customs authorities in relation to CE marking?

Manufacturers can place a CE (Conformité Européenne) mark on a medical device once it has passed a conformity assessment. The conformity assessment usually ... The rules for affixing UKCA or CE marking to a product are the same. In most cases, businesses must apply the UKCA or CE marking to the product's surface or ... CE Marking is Europe's version of marketing approval. Click through the below steps to see the high-level process to CE Mark IVDs. Oct 28, 2024 ... There are more than thirty CE marking directives and regulations. Each one covers a certain product scope and sets the requirements for manufacturers, ... 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. May 11, 2024 ... New approach CE marking Directives. The declaration of conformity and the CE marking are the two instruments which allow the free circulation of ... AT A GLANCE. • The CE Mark in the European Union and the FDA approval process in the United States both perform the same functions, namely assessing the safety ... 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 ... All products imported or sold in the EU must have the CE Mark. Affixing the CE Mark to a product indicates that it has been tested and meets the required ... We are regulatory professionals who guide on specific requirements that must be met and obtain the medical device CE Marking.