Audits and Inspections of Category III PPE
Category III PPE can be placed on the market only after having undergone the conformity assessment process provided for by Regulation (EU) 2016/425.
ASSISTANCE
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Form C2
Module C2 provides for periodic checks on the product, carried out at least annually.
The Notified Body carries out:
- Sampling of PPE placed on the market
- the laboratory tests required to verify the conformity and consistency of production with the EU Type Examination Certificate (Module B)
Following the checks carried out, the Notified Body proceeds to issue the Module C2 Certificate.
Form D
Module D is based on the assessment and surveillance of the manufacturer’s quality management system.
Activities include:
- Initial audit of the quality system related to the design and/or manufacture of PPE
- Verification of the implementation of procedures
- periodic surveillance audits
This procedure ensures that PPE is produced in a compliant and controlled manner, in compliance with the Module B Certificate and regulatory provisions.
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