Medical Device Regulation in USA is formulated and controlled by FDA via Section 510k of the act. However, in Europe its via MDD directive so called CE Marking Reading this article will help those unfamiliar with 510k and CE marking effectively prioritize their regulatory efforts. 510(k) is the preferred route to reach the Largest single market (USA) whereas CE Marking is the preferred route to reach 37 European counties and very interestingly it is widely accepted […]
A Competent Authority is the body, which has the authority to act on behalf of the government of a member state to ensure that the requirements of the Medical Devices CE Marking directives are carried out in that particular member state. The European Union (EU) comprises 28 member states. Each member state is party to the founding treaties of the union and thereby subject to the privileges and obligations of membership. Notified Body is a […]
Is CE MARKING valid ACROSS the world market? No. CE marking is required for the European market only. It is valid in all 32 countries of the European Economic Area. But its sure without any doubt, CE marking make it easier to obtain access to other markets, such as Australia, India, Middle East Countries, Turkey.