PPE Personal Protection Certification

Personal Protective Equipment PPE Regulation (EU) 2016/425

(Replace the old directive 89/686/EEC)

1. Introduction

This regulation specifies the design and manufacturing requirements for personal protective equipment (PPE) to ensure the health and safety of users, and establishes rules for the free circulation of PPE within the alliance.

2. Applicable product scope

1. This regulation applies to PPE personal protective equipment

2. Personal protective equipment not covered by this regulation:

(a) Specially designed for the use or maintenance of law and order by armed forces;

(b) Used for self-defense, except for personal protective equipment used for sports activities;

(c) Specially designed for personal use to prevent:

(i) Adverse atmospheric conditions,

(ii) Moisture and water during dishwashing;

(d) Applicable exclusively to ships or aircraft in accordance with relevant international treaties applicable to member states;

(e) Applicable to the protection of the user's head, face, or eyes, this is covered by the United Nations Economic Commission for Europe Regulation No. 22, which is a unified regulation on the approval of protective helmets and face shields for motorcycle and light motorcycle drivers and passengers.

3. Definition of PPE

Personal protective equipment (PPE) refers to:

(a) Equipment designed and manufactured to prevent a person's health or safety from being compromised by one or more risks;

(b) The interchangeable components of the equipment mentioned in point (a) that are crucial for its protective function;

(c) (a) The connection system for non-human held or worn devices mentioned aims to connect the device to an external device or reliable anchor point, is not designed to be permanently fixed, and does not require fastening work before use;

4. EU Declaration of Conformity

1. The EU declaration of conformity shall declare that it has been demonstrated to comply with the applicable basic health and safety requirements listed in Annex II

2. The EU declaration of conformity should have the pattern structure listed in Annex 9, including the elements specified in the relevant modules listed in Annex 4, 6, 7, and 8, and should be continuously updated. It should be translated into one or more languages required by the member states where PPE is placed or provided in the market.

3. If PPE is bound by more than one union act requiring an EU declaration of conformity, an EU declaration of conformity should be drafted for all such union acts. The statement should include an assessment of union behavior, including its publication references

4. Manufacturers shall be responsible for whether PPE complies with the requirements of this regulation by drafting an EU declaration of conformity.

5. Rules and conditions for affixing CE mark

1. The CE mark should be prominently, clearly, and irrevocably affixed to PPE personal protective equipment. If personal protective equipment cannot be directly attached to the equipment due to its nature, it should be affixed to the packaging and accompanying documents.

2. Personal protective equipment (PPE) must be affixed with the CE mark before being put on the market

For Class III personal protective equipment, the identification number of the notified body involved in the procedures listed in Annex 7 or 8 should be added after the CE mark. The identification number of the notified body should be affixed by the institution itself or by the manufacturer or its authorized representative under its instructions.

4. CE marking, and where applicable, the identification number of the notified body may be followed by a pictogram or other symbol indicating the risks that PPE is intended to protect.

5. Each member state should use existing mechanisms as a basis to ensure the correct application of the relevant symbol system and take appropriate action when the symbol is improperly used

6. Risk categories of personal protective equipment (PPE)

Personal protective equipment should be classified according to the risk categories in Appendix I. For detailed information, please refer to the information download

7. Compliance Assessment Procedure

The conformity assessment procedures for each risk category listed in Annex 1 are as follows:

(a) Class I: Internal Production Control (module A);

(b) Class II: EU type -examination (module B), Compliance of internal production control based on module C;

(c) Class III: EU type examination (module B) plus any of the following:

(i) According to the internal production control and supervision, the time interval for product spot checks meets the type (module C2);

(ii) Quality assurance based on production process compliance type (module D)

By way of derogation, for PPE produced as a single unit to fit an individual user and classified according to Category III, the procedure referred to in point (b) may be followed.

Product Category

Conformity assessment procedure

class I

module A

class ii

module B+ module C

class iii

module B+ module C2

module B+ module D

module A:  Internal production control

Module B: EU Form Check

module C： Internal production control

module C2： Internal production control+random interval supervision product inspection

module D： Consistency assurance in the production process

8. PPE certification process



9. Download relevant documents

Annex I Risk Categories of PPE Risk Categories

ANNEX II ESSENTIAL HEALTH AND SAFETY REQUIRements Basic Health and Safety Requirements