Process of Conformity and CE Marking: Key entities

The Authorized Representative (AR)

A natural or legal person established in the EU explicitly designated by a non-European manufacturer who acts on behalf the manufacturer in carrying out certain tasks required in the applicable regulations.

The Notified Body (NB)

An organization or entity that has been appointed and accredited by a Competent Authority to assess and ensure conformance to the requirements set forth in the directives. An NB will be nominated based on designated requirements, such as knowledge, experience, independence and resources to conduct the conformity assessment.

The Competent Authority (CA)

A person or entity that has the authority to act on behalf of the government of the Member State to ensure that the requirements of the MDR and IVDR are transposed into national law and applied. Each Member State has a CA responsible for medical devices. Each Member State has a CA responsible for medical devices.

The Manufacturer

A natural or legal person who manufactures or fully refurbishes a device or has a device designed, manufactured or fully refurbished, and markets that device under its name or trademark.