Notified bodies

Notified Bodies, also known as Notified Bodies, are certification bodies authorised by the state to carry out tests and assessments for conformity assessments. In Germany, Notified Bodies are authorised by the notifying 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).

Notified Bodies of the European Union are defined in § 3 of the MPG and are independent organizations / certification bodies appointed by an EU member state. Notified Bodies outside the EU can be designated by the Commission of the European Union according to Directive 2006/654/EC.

The Notified Bodies are auditing and certification bodies monitored in accordance with DIN EN ISO/IEC 17000 and the EU harmonisation directives. They assess the essential requirements laid down in the harmonization directives with regard to the product characteristics of medical devices and compliance with the prescribed conformity assessment procedures. According to the declaration of conformity issued by the manufacturer, the CE marking may be affixed to the product.

Manufacturers of products may designate the certification body to carry out the conformity assessment procedure in accordance with the applicable directive.