Centexbel is the first Belgian Notified Body (# 0493)
to be recognized to apply the new EU Regulation 2016/425/EEC that harmonizes the legislation of the EU member states with respect to Personal Protective Equipment.
This means that all PPE articles certified by Centexbel can immediately be freely marketed in all countries belonging to the European Economic Area (EEA).
What is it all about?
CE-marking, in force since 1993, has to be affixed by the manufacturer or distributor of imported goods. By affixing the CE-mark on his products, the manufacturer/distributor declares that he has respected all CE marking obligations and becomes responsible for the traffic of the products in the AAE.
The CE-mark shows that the product has been evaluated and is conform with the European requirements related to safety, health and environmental protection. The CE-mark is valid for products manufactured within the EEA and for products manufactured outside the EEA and then introduced on the EEA market.
When do you, as a manufacturer or distributor of imported PPE, have to apply to our services as Notified Body?
The intervention of a Notified body is primarily needed for EU type examination of category II and III PPE and during the quality monitoring of category III PPE. PPE belong to category I do not require a formal intervention by a notified body, but a notified body can always act as an advisor of laboratory.
Nando (New Approach Notified and Designated Organisations) Information System
Notification is an act whereby a Member State informs the Commission and the other Member States that a body, which fulfils the relevant requirements, has been designated to carry out conformity assessment according to a directive. Notification of Notified Bodies and their withdrawal are the responsibility of the notifying Member State.