Steps for Getting CE Marking
All products meeting the definition of medical devices as defined by the EU regulations require CE marking before they can be sold in the EU . CE marking indicates that a product has been assessed by the manufacturer and meets EU safety, health, and environmental protection requirements. It is required for products manufactured anywhere in the world that are then marketed in the EU. The product must comply with all the relevant MDD to MDR requirements of before affixing the CE marking to it. Although the compliance requirements are similar in many ways, the European route is thought to be less governmental, resulting in shorter times to market, greater acceptance rates of new devices, and lesser costs associated with obtaining conformity certification. While the benefits of obtaining a CE marking are significant, regulations are always subject to change. New modifications to the European medical device requirements are making the process more similar to that of ...