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Personal Protective Equipment CE Certification — PPE Certification

The fundamental directive for CE certification of personal protective equipment is 89/686/EEC. Adopted through legislation by the former European Community (EC), this directive was formally adopted as Regulation No. 686 by the European Parliament and the European Council in 1989, and entered into mandatory force on 1 July 1995. It has undergone three revisions: 93/68/EEC, 93/95/EEC and 96/58/EEC.

With the upgrading of the EU regulatory system, 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. At present, the requirements of the new directive are fully applicable to the European market.

The PPE Directive (Personal Protective Equipment Directive) is a mandatory regulation formulated by the European Union for personal protective equipment. It establishes a clear legal framework to ensure that PPE products placed on the European market are equipped with reliable hazard protection capabilities.

Its core contents include:

Essential Health and Safety Requirements (EHSR): Mandatory technical specifications for product safety performance
Conformity assessment procedures: Standardized verification routes to confirm products comply with directive requirements
Compliance routes: Manufacturers or EU authorised representatives can achieve compliance in two ways, either by directly meeting the directive requirements or complying with European harmonised standards (EN Standards)

Highlights of the updated Directive (EU) 2016/425:

Expand the definition scope of PPE to cover more new types of protective products
Strengthen market surveillance mechanisms and increase penalties for violations
Optimize the product classification system to realize more accurate risk grading
Introduce the concept of full life cycle safety management covering all links including design, production and circulation

基本要求

Products shall meet the following core technical specifications:

Structural Safety and Ergonomics
Product design must ensure safe use and comply with ergonomic principles, fully taking into account differences in body shapes, operating habits and long-term wearing requirements of different users.
Comfort and Protection Effectiveness
A balance shall be struck between product comfort and protection performance to prevent protection failure caused by uncomfortable wearing; the product shall deliver effective protection under specified conditions of use.
Material Safety
Selected materials shall feature adequate durability and stability. Substances that may cause physical injury or health risks to users are prohibited, and the materials shall not hinder the performance of protective functions.
Adaptability to Special Scenarios
For specific working environments (such as high temperature, chemical exposure, working at height, etc.), additional special safety protection requirements shall be satisfied.

评审模式

Depending on the product risk level, six conformity assessment modules are available for PPE certification:

Module Code	Module Name	Core Requirements	Application Scenarios
A	Internal Production Control	The manufacturer establishes its own quality control system and issues 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 and low-risk products
D	Production Quality Assurance	Quality system certification is required, and the notified body supervises the production process	Medium and high-risk products
E	Product Quality Assurance	Quality system certification is required, and the notified body supervises final inspection	Medium and high-risk mass-produced products
F	Product Verification	Each batch shall be sampled and tested by a notified body, and the CE marking shall be affixed after certification	Medium-risk mass-produced products
H	Full Quality Assurance	Full quality system certification is required, and the notified body supervises 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 documentation and certification-related records shall be kept for at least 10 years after the product is withdrawn from the market for inspection by EU market surveillance authorities.
Change Management
Where significant changes occur to product design, materials, production processes, etc., corresponding compliance assessments shall be carried out again.
Supply Chain Responsibilities
Importers and distributors shall verify the validity of the CE certification of products and ensure that the sold products are accompanied by complete technical documentation and declaration of conformity.
Market Surveillance
Customs and market supervision authorities of EU Member States have the right to conduct random inspections on PPE products in circulation. Non-compliant products will be subject to recall and penalties.

Service Process

EC Type Examination Procedure

EC Type Examination is a key procedure to verify whether products comply with directive requirements, implemented by EU notified bodies. The detailed process is as follows:

1. Application Submission

The manufacturer or its EU authorised representative submits an application to the designated notified body, which shall include:

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

2. Documentation Review

The notified body reviews the completeness and compliance of technical documentation to confirm conformity with the directive and relevant standards.

3. Sample Testing

Samples passing documentation review shall undergo full performance testing and safety assessment to verify consistency between actual performance and technical documentation.

4.Result Feedback

Qualified products: EC Type Examination Certificate will be issued
Non-compliant products: A detailed non-conformity report will be issued. The applicant may re-apply after rectification.

Complete Certification Process

1. Preliminary Preparation

Clarify the PPE category of the product (Class I, Class II and Class III based on risk level), sort out applicable regulations and standards, and prepare technical documentation.

2. Module Selection

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

3. Compliance Assessment

Complete type testing, quality system certification and other procedures in accordance with requirements of the selected module.

4. Declaration of Conformity

The manufacturer signs the EU Declaration of Conformity, specifying the directive clauses and standards complied with by the product.

5. Affixing CE Marking

Affix the CE marking on a conspicuous position of the product. The marking shall be clear, durable and traceable. Imported products shall also be marked with importer information.

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