The CE marking is an important indicator that a product complies with European Union (EU) legislation. This marking confirms that the product meets high safety, health and environmental protection requirements. The CE marking process for Personal Protective Equipment (PPE) is regulated by Regulation 2016/425, which provides a framework to ensure the safety of users.
What is Regulation 2016/425?
Regulation 2016/425 establishes the legal basis for the production and placing on the market of PPE within the EU. It defines the essential health and safety requirements that PPE must meet before it can be placed on the market. This regulation covers a wide range of equipment aimed at protecting users against health and safety risks, such as helmets, gloves, protective footwear and respiratory protection devices.
Key Obligations for Manufacturers
- Risk Assessment: Manufacturers must carry out a detailed risk assessment to identify the specific hazards for which the PPE is designed.
- Technical Documentation: A comprehensive technical file including design specifications, test results and conformity assessments must be prepared.
- EU Declaration of Conformity: Manufacturers must issue an EU Declaration of Conformity declaring that the PPE complies with Regulation 2016/425.
- CE Marking: Once conformity has been confirmed, PPE may be affixed with the CE marking. This mark ensures the free movement of goods in the EU market.
Role of Notified Bodies
Some categories of PPE require the involvement of a Notified Body such as USB Certification (Notified Body No: 3038). The Notified Body verifies compliance with the regulation by performing conformity assessments such as type examination and quality assurance procedures.
PPE Classification
Regulation 2016/425 divides PPE into three categories according to their risk level:
- Category I: Simple PPE for minimal risks.
- Category II: PPE for moderate risks requiring a type examination.
- Category III: Complex PPE for high-risk situations requiring type examination and continuous inspection by a Notified Body.
Common Problems and FAQs
- How long is the CE marking valid?
The CE marking varies between modules, but generally remains valid as long as the relevant legislation is complied with and there is no significant change in the design of the PPE. However, some certificates may need to be renewed for certain periods for high-risk situations.
- What happens if PPE is non-compliant?
Non-compliance can result in sanctions such as fines, recalls and removal from the EU market. Manufacturers are advised to cooperate with a Notified Body to ensure compliance.
- Are there additional requirements for PPE sold online?
Yes, PPE sold online must comply with the same regulatory standards as PPE sold in physical stores. Manufacturers and distributors must ensure that product descriptions are accurate and comply with Regulation 2016/425.
USB Certification Test Inspection Laboratory Certification Services (Notified Body No: 3038) specializes in assisting manufacturers with the CE marking process for PPE. Our team of experts offers comprehensive conformity assessment services to ensure that your products meet the requirements of Regulation 2016/425.
For more information about our services, please visit www.usb-lab.com .
