After the type examination of a category III PPE has been approved, the manufacturer must make an agreement on quality control with the notified body. The manufacturer can choose the one that suits them the best as a model for quality control from the options provided for in the regulation.
Module C2: Conformity to type based on internal production control and monitored product checks at random intervals
In module C2, the manufacturer demonstrates that its production process and quality control ensure that the PPE is in compliance with the type as described in the EU-type examination certificate and with the applicable requirements.
The notified body will also carry out product checks at least once a year. Product checks can be carried out by a different notified body than the one that performed the EU-type examination.
Module C2 is described in more detail in Annex VII to the PPE Regulation.
In module D, the manufacturer demonstrates that it has an appropriate quality system for the production process to ensure that the appliances are in compliance with the type as described in the EU-type examination certificate, and that they meet the applicable requirements.
In addition, the notified body carries out an audit of the factory at least once a year. The notified body can also make unannounced on-site visits and test products to ensure proper functioning. The audit of the factory can be carried out by a different notified body than that which performed the EU-type examination
Module D is described in more detail in Annex VIII to the PPE Regulation.