Notifizierungsstelle

Notifizierungsstelle is a term used in German-speaking regulatory contexts to denote an organization that has been designated by a national authority to perform official conformity assessment or notification tasks under specific laws. In the European Union, Notifizierungsstelle is closely related to the concept of a Notified Body, or in German often "benannte Stelle" or "Notifizierte Stelle": organizations authorized to assess whether products meet the essential requirements of EU directives and to issue conformity certificates. The designation is performed by a national competent authority and requires formal accreditation.

Notified bodies participate in conformity assessment procedures for a wide range of products, including medical devices, electrical equipment, machinery, construction products, and personal protective equipment. They may carry out testing, inspection, calibration, and audit of the manufacturer's quality management system, depending on the directive. If a product complies, the Notifizierungsstelle issues an EC-type examination certificate, a quality management system certificate, or a conformity assessment report, which the manufacturer uses to affix CE marking.

The list of notified bodies is published by the European Commission's NANDO database, and ongoing surveillance and re-assessment ensure continued compliance. National authorities are responsible for designation, monitoring, and withdrawal of the designation if requirements are not met. In German practice, the term more commonly encountered is "benannte Stelle", but translations vary.

Notifizierungsstelle can also refer to national authorities or agencies responsible for official notifications or registrations under other regulatory frameworks, such as chemical safety or product registration, where a formal acknowledgment or certification is required for market access.