PPE Testing and CE Marking under Regulation (EU) 2016/425
Personal protective equipment (PPE) may only be placed on the EU market if it meets the essential health and safety requirements of Regulation (EU) 2016/425. EVERBIZ supports manufacturers with testing against harmonised standards, preparation of technical documentation and readiness for the applicable conformity assessment procedure.
PPE Categories and Conformity Assessment
- Category I – minimal risks only: internal production control (Module A).
- Category II – risks not covered by Category I or III: EU type-examination by a notified body (Module B) plus conformity to type (Module C).
- Category III – risks with very serious consequences, e.g. respiratory protection or protection against hazardous substances and biological agents: Module B combined with Module C2 or Module D.
Our Testing Focus
- Protective clothing against infective agents – EN 14126
- Protective gloves against micro-organisms – EN ISO 374-5
- Filtering half masks to protect against particles (FFP1/FFP2/FFP3) – EN 149
Our Services
- Product classification and selection of applicable standards
- Test planning and coordination of test samples with testing laboratories
- Preparation of technical documentation, instructions for use and EU Declaration of Conformity
- Support during EU type-examination by a notified body
- Review of labelling and packaging information
Note: PPE with a Medical Purpose
Products such as examination gloves or protective masks may fall under both the Medical Device Regulation (EU) 2017/745 and the PPE Regulation when they are intended to protect both the patient and the user. In that case, the requirements of both regulations must be met. We review the classification and plan the evidence so that duplicate testing is avoided.
Contact us – we will be glad to prepare a testing and certification plan for your PPE.