Notified body in clinical studies

Author:Prof. Dr. med. Peter Altmeyer

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Last updated on: 29.10.2020

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Synonym(s)

Notified body

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DefinitionThis section has been translated automatically.

Notified Bodies are state-authorised certification bodies that carry out tests and assessments for conformity assessments. In Germany, Notified Bodies are authorised by the designating authority (Central Authority of the Federal States for Health Protection with regard to Medicinal Products and Medical Devices - ZLG) in accordance with § 15 of the Medical Devices Act (MPG). The best known Notified Bodies are e.g. TÜV (Technischer Überwachungsverein) and DEKRA.

Authors

Last updated on: 29.10.2020

Author: Prof. Dr. med. Peter Altmeyer