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The CE Mark (or CE marking) is a symbol indicating that a product meets the requirements of European Medical Device Directives and Regulations (MDD). If a company wants to market a medical device in the European Union, it must have a CE mark on the product. The requirements of the MDR and EU CE Mark apply to all devices. EuropeCert is a full service provider of regulatory consulting and MDR certification services. EU MDR regulations require all medical devices to be marked with the CE Mark. The process of compliance has changed significantly with the new regulation. Kolabtree's Sophie Laurenson, an EU CE Mark MDR Medical Device Consultant , explains the major changes in the new MDR and their implications. In this article, she covers the major changes and what the implications are for your company. Read on to learn more. When it comes to the MDR, there are a lot of changes and pitfalls to avoid. The MDR will change the way the European Union regulates medical devices. It is being ph