For which risk category?
Module C2 is a specific procedure for category III PPE
REQUEST MODULE C2?
The manufacturer or its legal representative submits a Module C2 application to Aliénor Certification accompanied by a Module C2 First Application Certificate attesting that the same application has not been submitted to another organization
DECISION MODULE C2
When the results of the evaluation activities are positive, Aliénor Certification issues a Module C2 decision proving that the production is homogeneous and that the PPE conforms to the type described in the AET
The manufacturer must display the CE mark with the number of the NB that made the C2 Module
Conformity to type on the basis of internal production control and supervised product checks at random intervals is the part of the conformity assessment procedure by which the manufacturer fulfills the obligations defined in Annex VII of Regulation 2016/425 and ensures that the PPE in question conforms to the type described in the EU type examination certificate and meets the requirements of the regulation
Why is this?
When the results of evaluation activities are positive, Eleanor Certification issues an EU type examination certificate proving that the PPE type meets the applicable essential health and safety requirements of Regulation 2016/425
How do you do it?
To verify the conformity of the PPE to the approved type, Eleanor Certification takes a statistical sample from the manufacturer's production site and applies the critical tests defined in the harmonized standards or in the other technical specifications.
The homogeneity of the production is verified by an audit of the means of production control
When will it happen?
The C2 Module is performed at least once a year at random intervals determined by Eleanor Certification. The first inspection is carried out at the latest 1 year after the date of issue of the EU type examination.