PPE Regulation 2016/425
The PPE directive contains all basic safety requirements which personal protective equipment must satisfy to guarantee the health protection and safety of users. The PPE Directive covers all PPE designed for use in professional, domestic, leisure and sports activities.
The PPE Regulation does not apply to:
- protective equipment designed for armed forces or law enforcement;
- protective equipment for self-defense against attackers;
- protective equipment designed for private use against weather conditions that are not of an extreme nature;
- protective equipment for exclusive use on seagoing vessels or aircraft;
- helmets and visors for users of two- or three-wheel motorcycles.
CE marking for Personal Protective Equipment (PPE) can be used to gain access to the European market. With the CE-mark you will declare that the equipment is in accordance with all legal requirements as defined in Regulation (EU) 2016/425.
PPE Categories
Personal protective equipment covered by the PPE Directive are separated into three categories and each has a different conformity assessment procedure.
Category I – Simple PPE
Only for PPE intended to protect users against minimal risks. Due to that, the conformity assessment procedure doesn’t include Notified body testing and evaluation. Manufacturers can self-declare compliance with the respective legislation.
Category II – Intermediate PPE
This category includes medium-risk PPE, other than those listed in Categories I and III. The conformity procedure required for Intermediate PPE involves Notified body assessment.
Category III – Complex PPE
PPE of complex design intended to protect the user against any risks with very severe consequences. The compliance process of complex PPE includes Notified body assessment and either on-going surveillance through testing or on-going inspection through factory auditing.
Our services for CE marking for the PPE Directive
We can identify the regulatory requirements for your product and offer you assistance and review of the technical documentation. We can help you with the CE marking process for all three categories. For personal protective equipment in category II and III an EC type examination is mandatory. In case your PPE falls into Category II or III which requires an EU-type examination, we will assign a Notified Body on your behalf. For the purpose of performing product tests we collaborate only with accredited test laboratories. This certification process guarantees your product and its documentation meet all mandatory provisions. After getting your type examination certificate, you can proceed and affix the CE mark on your product. In short we help you with:
- Implementation of full CE conformity assessment procedures
- Qualification and classification of your PPE product(s)
- Perform the risk analysis
- Perform (or outsource) product tests in accordance with European (harmonised) standards
- Designate a Notified Body and provide consultancy services in regard to the implementation of EU-type examination
- Compilation and assessment of the Technical Documentation
- Verify instruction manuals, markings and label (safety information)
- Draw up the EU Declaration of Conformity and provide instructions for affixing the CE marking