What is PPE?
PPE, short for “2016/425/EU Personal Protective Equipment,” refers to equipment designed to protect individuals from specific risks in workplaces.
Which Products Fall Under PPE?
The 2016/425/EU Personal Protective Equipment Regulation covers all equipment designed to protect users from specific hazards. Examples include:
- Masks, goggles, and protective clothing for hazardous environmental conditions,
- Helmets, gloves, and work shoes to guard against impacts or falls,
- Ear protection against noise,
- Lifelines and safety harnesses for fall prevention,
- Specialized equipment to protect athletes.
However, certain items, such as dishwashing gloves designed for specific purposes, are excluded from this regulation.
At SERTİFİKE, we provide comprehensive consultancy services to determine the category of PPE products and ensure compliance with regulatory requirements.
Is the CE Mark Mandatory for PPE Products?
All personal protective equipment falling under the 2016/425/EU Regulation is legally required to carry the CE mark. Manufacturers and authorized representatives must complete the CE marking process before placing their products on the market.
The CE mark not only confirms compliance with relevant standards but also allows the product to be freely sold in European Union countries.
SERTİFİKE assists you in meeting CE marking requirements, ensuring your products are both legally and commercially ready.
What Does the CE Mark Indicate for PPE Products?
The CE mark on PPE products signifies that the item complies with relevant regulations and standards. It ensures that the product has been evaluated and deemed safe for human health and the environment.
How to Obtain the CE Mark for PPE Products?
PPE products are categorized based on the complexity of the risks they protect against:
- Category I: Simple-design products (e.g., sunglasses, household gloves).
- Category II: Products addressing intermediate-level risks.
- Category III: Products protecting against complex risks (e.g., firefighting equipment, masks).
- For Category I products, manufacturers can self-declare compliance and use the CE mark.
- For Category II and Category III products, services from notified bodies are mandatory.
Category III products, in particular, require a Type Examination Certificate (Module B) along with additional documents evaluating the production processes, such as Module C2 or Module D.
SERTİFİKE offers expert support in managing module-based processes and preparing necessary documentation.
Who Can Issue CE Certificates?
Only notified bodies authorized by the European Union and possessing a 4-digit identification number can issue CE certificates under the PPE regulation. Certificates from unauthorized bodies are considered invalid.
At SERTİFİKE, we collaborate with trusted and authorized notified bodies to complete the certification process for your products securely and reliably.
