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PERSONAL PROTECTIVE EQUIPMENT (PPE) TESTING & CERTIFICATION

Independent technical guidance for personal protective equipment (PPE) in accordance with EU regulatory requirements.

We support manufacturers and importers in preparing PPE for EU market access under Regulation (EU) 2016/425 by defining applicable requirements, assessing documentation readiness, and supporting conformity assessment preparation.

PPE compliance requires clear identification of intended use, risk category, applicable standards, and the relevant conformity assessment route.

our approach to Regulation (EU) 2016/425 certification

For certain PPE categories, involvement of a Notified Body is required depending on the applicable conformity assessment route.

Protective gloves

Eye and face protection

Hearing protection

Respiratory protective devices and protective clothing

Safety footwear and helmets

Fall protection equipment

PPE certification supports placing personal protective equipment on the EU market in accordance with Regulation (EU) 2016/425.

The Regulation defines essential health and safety requirements and establishes conformity assessment procedures depending on PPE category and associated risk level.

Assessment is typically performed against relevant harmonised standards and includes evaluation of:

  • Product design and construction 
  • Materials and performance characteristics 
  • Test evidence and laboratory results 
  • Assessment of manufacturing processes and quality system
  • Marking, labeling, and user instructions

Regulation (EU) 2016/425 CERTIFICATION PROCESS

Scope definition & Readiness Review

Confirmation of applicability under Regulation (EU) 2016/425, including determination of PPE category, intended use, and applicable conformity requirements.

Documentation Review and Gap Assessment

Evaluation of technical documentation, labeling, and user instructions to identify gaps against regulatory and standard requirements.

Testing and Conformity Assessment Support

Coordination of testing activities and support during conformity assessment procedures, including interaction with Notified Bodies where required.

Assessment of manufacturing processes and quality system

Evaluation of production processes and quality management system to ensure ongoing conformity of manufactured products with the approved type and applicable requirements.

Final Documentation and Market Readiness

Preparation of technical documentation and supporting evidence required for CE marking and placing PPE on the EU market.

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WHY DANEM TEST & CERTIFICATE

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  • Global Expertise
    International team supporting certification and compliance projects worldwide
  • Independent Assessment
    Transparent and impartial certification, testing, and audit processes
  • Prompt communication and fast response times. Faster certification and testing processes through responsive communication, streamlined workflows, and continuous project oversight
  • Structured Certification Pathways
    Clear project planning from assessment through approval
  • Technical & Regulatory Knowledge
    Support across certification, testing, regulatory requirements, and market access.

FAQ

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The conformity assessment route for Personal Protective Equipment (PPE) is determined by the product’s risk category under the PPE Regulation (EU) 2016/425.

PPE is classified into three categories based on the level of risk against which it is intended to protect:

  • Category I – Protection against minimal risks. Manufacturers may perform internal production control and self-declare conformity.
  • Category II – Protection against risks that are neither minimal nor very serious. EU-type examination by a Notified Body is required.
  • Category III – Protection against serious or life-threatening risks. In addition to EU-type examination, ongoing production surveillance or quality assurance assessment by a Notified Body is required.

Correct categorization is essential, as it determines the applicable conformity assessment procedure, the level of Notified Body involvement, and the documentation required for CE marking.

No. The involvement of a Notified Body depends on the PPE category and the level of risk associated with the product.

For Category I PPE (protection against minimal risks), manufacturers may carry out the conformity assessment procedure themselves without the involvement of a Notified Body.

For Category II and Category III PPE, a Notified Body is required to perform the applicable conformity assessment activities. Category III PPE additionally requires ongoing production surveillance or quality assurance assessment to ensure continued compliance.

A product-specific classification is therefore necessary to determine the appropriate conformity assessment route and the level of Notified Body involvement.

In many cases, yes. A single PPE certification may cover multiple product variants, models, or size ranges, provided they are based on the same fundamental design and do not introduce differences that could affect safety performance or compliance with applicable requirements.

The extent of coverage depends on factors such as materials, construction, protective functions, manufacturing processes, and performance characteristics. Variants that differ significantly may require additional assessment, testing, or inclusion within the certification scope.

A technical review is typically performed to determine whether product variants or size ranges can be covered under the same certification or whether separate conformity assessment activities are necessary.

A PPE technical file typically includes documentation demonstrating the design, performance, and compliance of the product with the requirements of Regulation (EU) 2016/425.

Depending on the PPE type and category, the technical file may include product specifications, design drawings, material information, risk assessment, performance test reports, user instructions, labeling details, manufacturing information, and evidence of compliance with applicable harmonised standards.

For Category II and Category III PPE, the documentation may also include EU-type examination certificates, quality assurance records, and other documents related to Notified Body involvement.

The technical file should provide sufficient information to demonstrate conformity with the applicable essential health and safety requirements and support the issuance of the EU Declaration of Conformity.

The duration of PPE preparation depends on the type of personal protective equipment, its risk category, the completeness of the technical documentation, and the applicable conformity assessment procedure.

For Category I PPE with well-prepared documentation and established product designs, preparation may take only a few days to a few weeks. Category II and Category III PPE generally require additional assessment, testing, and Notified Body involvement, which may extend the timeline.

Additional time may also be required if product modifications, performance testing, or documentation updates are necessary to demonstrate compliance with Regulation (EU) 2016/425. Early review of product specifications, applicable standards, and technical documentation can help reduce delays during the conformity assessment process.

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