CE marking of personal protective equipment, PPE
Personal protective equipment (PPE) placed on the EU market must comply with the requirements of Regulation (EU) 2016/425 and bear the CE marking. RISE is a Notified Body under the Regulation. We carry out the assessments required to verify that your product complies with the applicable regulatory requirements.
This service is also relevant in: Metrology, Production and manufacturing, Health and life science
Service details
- Service
- CE marking of personal protective equipment, PPE
- Price
- Price on tender
- Preparations
A first contact with Certification at RISE should be made as early as possible when a product is to be certified.
Our product certification services help you get the right conditions for a successful certification, understand the requirements and plan the process. Read more here
Order
Purpose
With RISE, you receive an independent and recognized basis for CE marking of personal protective equipment (PPE). We assess both the product and the technical documentation, issue the necessary certificates, and guide you through the entire process.
About Personal Protective Equipment (PPE)
Personal protective equipment (PPE) is equipment designed to be worn or used by an individual to protect against risks to health and safety.
Examples of personal protective equipment include:
- Safety helmets
- Safety footwear
- Eye and face protection
- Respiratory protective equipment
- Fall protection equipment
- High-visibility clothing
- Chainsaw protective clothing
- Reflectors
Harmonised Standards
Harmonised standards are available for many types of personal protective equipment (PPE). If your product is designed and assessed in accordance with a harmonised standard, you can demonstrate compliance with the applicable requirements of Regulation (EU) 2016/425.
If harmonised standards are not used, RISE can help develop an evaluation plan and verify that the product meets the relevant requirements of the Regulation.
Process and Deliverables
- EU Type Examination (Module B)
You submit an application and the technical documentation to RISE. We review the documentation and assess the product against the requirements of Regulation (EU) 2016/425.
If the product meets the applicable requirements, RISE issues an EU Type Examination Certificate. The certificate is normally valid for five years.
- Assessment of Finished Products (Module C2)
For Category III personal protective equipment (PPE), ongoing surveillance is required after the EU Type Examination Certificate has been issued. RISE carries out sampling and testing of finished products to verify their continued conformity with the approved type.
The results are documented in an assessment report. When the requirements are met, you may use RISE’s identification number as a Notified Body alongside the CE marking.
- Quality System Assessment (Module D)
As an alternative to Module C2, you may choose Module D. Under this procedure, RISE assesses your quality management system for production, final inspection, and testing.
Following a successful assessment, a Production Quality Assurance Certificate is issued. The certificate entitles you to use RISE’s identification number as a Notified Body alongside the CE marking.
More information
It is the manufacturer's responsibility to ensure that the product complies with the requirements of Regulation (EU) 2016/425 and is correctly CE marked.
A manufacturer is any person or organisation that places personal protective equipment (PPE) on the market under its own name or trademark, regardless of whether the product is manufactured in-house or by another party on its behalf.
Link to the Commission's website PPE
Contact us
Need to CE mark personal protective equipment (PPE)? Contact us and we will help you identify the right route to CE marking and guide you through the conformity assessment process.