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Personal Protective Equipment CE Certification — PPE Certification

The foundational directive for CE certification of Personal Protective Equipment (PPE) is 89/686/EEC. Enacted by the former European Community (EC), this Regulation No. 686 was formally adopted by the European Parliament and the European Council in 1989, mandatorily taking effect on 1 July 1995, and has undergone three revisions: 93/68/EEC, 93/95/EEC and 96/58/EEC.

With the upgrading of the EU regulatory framework, Directive (EU) 2016/425 issued in March 2016 has fully replaced 89/686/EEC. The new directive entered into force on 21 April 2018 with a transition period ending on 21 April 2023, and its requirements are fully applicable to the European market at present.

The PPE Directive is a mandatory regulation formulated by the European Union for personal protective equipment. It establishes a clear legal framework to ensure that all PPE products placed on the European market deliver reliable protection against hazards.

Its core contents include:

Essential Health and Safety Requirements (EHSR): Mandatory technical specifications governing product safety performance
Conformity Assessment Procedures: Standardized verification routes to demonstrate product compliance with directive requirements
Compliance Pathways: Manufacturers or EU Authorised Representatives may achieve compliance either by directly meeting the directive’s provisions or by complying with European Harmonised Standards (EN Standards)

Highlights of upgrades under the new Directive (EU) 2016/425:

Expanded definition of PPE to cover more innovative protective products
Strengthened market surveillance mechanisms and harsher penalties for non-compliance
Optimized product classification system enabling more precise risk grading
Introduction of full-lifecycle safety management covering all stages from design and production to distribution

基本要求

Products shall comply with the following core technical specifications:

Structural Safety and Ergonomics
Product design must guarantee safe use and conform to ergonomic principles, fully taking into account differences in body shapes, operating habits and long-term wearing requirements of various users.
Comfort and Protective Effectiveness
A balance shall be struck between product comfort and protective performance to prevent protection failure caused by uncomfortable wearing; the protective functions shall work effectively under specified service conditions.
Material Safety
Selected materials shall possess corresponding durability and stability. Substances that may cause physical injury or health risks to users are prohibited, and the materials shall not impede the realization of protective functions.
Adaptability to Special Scenarios
Additional special safety protection requirements shall be met for specific working environments (such as high temperature, chemical exposure, high-altitude operation, etc.).

Assessment Mode

Depending on different product risk levels, six conformity assessment modules are available for PPE certification:

Module Code	Module Name	Core Requirements	Applicable Scenarios
A	Internal Production Control	The manufacturer shall establish its own quality control system and issue a self-declaration of conformity	Low-risk products (e.g. general protective gloves, safety helmets)
B	Type Examination	EC type examination is required, production consistency shall be maintained, and self-declaration shall be issued	Medium-low risk products
D	Production Quality Assurance	Quality system certification is required, and notified bodies shall supervise the production process	Medium-high risk products
E	Product Quality Assurance	Quality system certification is required, and notified bodies shall supervise final inspection	Mass-produced medium-high risk products
F	Product Verification	Each batch of products shall undergo sampling testing by a notified body, and the CE mark shall be affixed after certification	Mass-produced medium-risk products
H	Full Quality Assurance	Full quality system certification is required, and notified bodies shall supervise design and production throughout the whole process	High-risk products (e.g. respiratory protective equipment, fall arrest systems)

Note: Modules D, E and H require ISO 9001 or equivalent quality system certification.

Notes

Document Retention
Technical documents and certification-related records shall be retained for a minimum of 10 years after the product is withdrawn from the market for inspection by EU market surveillance authorities.
Change Management
Corresponding conformity assessment shall be repeated in case of significant changes to product design, materials, production processes, etc.
Supply Chain Responsibilities
Importers and distributors shall verify the validity of the CE certification of products and ensure complete technical documentation and declaration of conformity are attached to the sold products.
Market Surveillance
Customs and market supervision authorities of EU Member States are entitled to conduct random spot checks on PPE products in circulation; non-compliant products will be subject to recall and penalties.

Service Process

EC Type Examination Process

EC Type Examination is a key procedure to verify whether products comply with directive requirements, carried out by EU Notified Bodies. The detailed procedures are as follows:

1. Application Submission

Manufacturers or their EU Authorised Representatives shall submit applications to designated Notified Bodies, including the following materials:

Basic information of the applicant entity (name, address)
Product manufacturing factory address
Complete technical documentation (design drawings, material specifications, test reports, etc.)
Representative samples of specified quantity

2. Document Review

The Notified Body reviews the completeness and compliance of technical documents to confirm conformity with directives and relevant standards.

3. Sample Testing

Full performance testing and safety assessment shall be conducted on samples passing document review to verify consistency between actual performance and technical documents.

4.Result Feedback

Qualified products: Issue EC Type Examination Certificate
Non-compliant products: Issue detailed non-conformity report; applicants may re-apply after rectification

Full Certification Procedure

1. Preliminary Preparation

Clarify the PPE category of the product (Category I, II, III classified by risk level), sort out applicable regulations and standards, and prepare technical documents.

2. Module Selection

Select the appropriate conformity assessment module according to product risk level, production scale and market positioning.

3. Conformity Assessment

Complete type testing, quality system certification and other procedures as required by the selected module.

4. Declaration of Conformity

The manufacturer signs the EC Declaration of Conformity to specify the directive clauses and standards with which the product complies.

5. CE Mark Affixation

Affix the CE mark on a prominent position of the product; the mark shall be clear, durable and traceable. Imported products shall be marked with importer information simultaneously.

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