EU PPE Regulation (EU) 2016/425 — three risk-based categories
Simple design PPE protecting against minimal risks. Manufacturer self-certifies — no Notified Body required.
e.g. Safety glasses, high-vis vests, basic gloves, sunglasses
PPE not in Category I or III. Requires EU Type Examination (Module B) by an approved Notified Body.
e.g. Safety helmets, hearing protection, safety boots, safety gloves
PPE protecting against life-threatening hazards. Requires Type Examination plus annual production quality assurance audit.
e.g. Respirators, fall harnesses, chemical protective suits
Complete PPE certification for Category I, II, and III products including safety equipment, protective clothing, and respiratory protection systems with full Notified Body support.
MDD and MDR compliance for all device classes with comprehensive clinical evaluation, risk management, and post-market surveillance support from our medical device experts.
LVD compliance and EMC testing for electrical equipment, household appliances, and electronic devices entering the EU market with comprehensive testing support.
Complete machinery compliance and risk assessment for industrial equipment, manufacturing machinery, and automated systems with comprehensive technical documentation.
CPR compliance and DoP preparation for building materials, structural components, and construction equipment with harmonized standards compliance support.
EN 71 compliance for mechanical, chemical, and electrical safety of toys and games for children of all ages with comprehensive age suitability evaluation.
RoHS compliance testing for restriction of hazardous substances in electrical and electronic equipment entering the EU market with comprehensive material analysis.
REACH compliance for registration, evaluation, authorization and restriction of chemicals with comprehensive substance identification and safety assessment.
General Product Safety Directive compliance for consumer products ensuring safety throughout the product lifecycle with risk assessment and market surveillance support.
Pressure Equipment Directive compliance for vessels, piping, safety accessories and pressure accessories with comprehensive conformity assessment and notified body support.
Streamlined approach to get your products certified efficiently
We analyze your product and determine the applicable directives and standards
Technical file preparation and gap analysis of existing documentation
Laboratory testing and conformity assessment by accredited bodies
Issue of certificates and preparation of Declaration of Conformity
Final CE marking application and market surveillance support
Contact our certification experts for a free consultation and quote