Who is a Competent Authority and a Notified Body?

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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 certification organization, which the national  Competent Authority of a member state designates to carry out one or more of the conformity assessment procedure according to Medical Device Directive and Issue CE Certificate.

Each notified body will be assigned one unique four digit number which will be affixed below the CE Mark logo.

 

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