Personal Protective Equipment (PPE) – CE Compliance According to Regulation (EU) 2016/425
Personal protective equipment is subject to Regulation (EU) 2016/425. For placement on the EU market, a completed conformity assessment procedure with CE marking is mandatory. The manufacturer bears the responsibility. If the manufacturer is located outside the EU, an authorised representative may be appointed – otherwise, the importer is considered the responsible economic operator.
PPE or not?
It is not always clear whether a product falls under the PPE Regulation. Additionally, the risk category (I, II, or III) must be determined, as it defines the extent and type of documentation required.
Typical classification questions we support with:
- Is a face covering considered PPE or a medical device?
- Do household gloves fall under the regulation?
- How should custom-made single items be classified?
Risk Category Determines Documentation Requirements
The regulation defines three categories with increasing requirements:
- Category I (low risk): Self-assessment by the manufacturer, internal production control, self-issued Declaration of Conformity.
- Category II (medium risk): EU-type examination by a Notified Body required.
- Category III (high risk): Additionally, an audit or quality assurance procedure is mandatory.
Importers must verify and document compliance with essential requirements before placing PPE on the market – regardless of the risk category.
Our Support – CE Compliance for PPE
We guide you through the implementation of the requirements – fully or for selected steps. Our services include:
- Review and assessment of existing test reports
- Coordination and commissioning of required conformity assessments
- Compilation of the technical documentation
- Drafting of labelling elements
- Preparation for the EU Declaration of Conformity