Compliance Procedures

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 or technical documentation that the PPE comply with the appropriate health and safety requirements comply as set out in the PPE Directive 89/686 EC and or its successor PPE Regulation (EU) 2016/425. Usually, the manufacturer will use specific product standards for his PPE. These product standards are the minimum technical requirements to which PPE must satisfy.

The manufacturer selects a Notified Body to certify his product.

This Notified Body assesses the application, including the technical documentation if it satisfies the legal requirements an EC type examination certificate or EU type certificate will be issued.

After approval PPE, bearing the CE mark and accompanied by a declaration of conformity, can brought into the internal (EU) market.

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

EU Member States are responsible for notifying these organizations.

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

The obligation of EU type examination does not apply to category I PPE so the manufacturer, if the product meets all requirements, may place it on the market without the intervention of a notified body. Also provided with the CE mark and declaration of conformity.