Notified bodies

Notified Bodies (Nobo) perform the prescribed conformity assessment procedures for category II and III PPE.

EU Member States are responsible for notifying these organisations.

Notified bodies should be technically competent and able to possess the conformity assessment procedures and the required level of independence, impartiality and integrity. Furthermore, the competence of the notified body is subject to monitoring by accreditation organizations.

The conformity procedure is also known as CE certification, EU type examination or EU type approval. The manufacturer shall demonstrate by means of a technical file that the PPE comply with the appropriate health and safety requirements as set out in the PPE Directive 89/686 / EC or its successor PPE Regulation (EU) 2016/425. Usually the manufacturer will use specific product standards. These product standards are the minimum technical requirements which PPE must satisfy.

The manufacturer selects a notified body to certify his product.

This notified body assesses the application, including the technical file and if they are in conformity with the requirements, an EU type examination certificate will be issued.

Only a product (cat II or III) which is approved by a notified body and has an EU type examination certificate shall bear the CE mark and have a declaration of conformity before entering the internal market for the first time.

The obligation of EU type examination does not apply to category I PPE so the manufacturer, in case the product meets all requirements (to be demonstrated with a technical file), may place the product on the market without the intervention of a notified body. Also provided with CE mark and declaration of conformity.

Check for an updated list of notified bodies: http://ec.europa.eu/enterprise/newapproach/nando