How to CE Mark Personal Protective Equipment (PPE) in 5 Steps

This guide explains the step-by-step CE marking process for products defined as Personal Protective Equipment under the EU PPE Regulation, from the manufacturer’s perspective. Products defined as PPE include the following:

• Sunglasses
• Skiing goggles
• Welding goggles
• Protective gloves
• Protective clothing
• Dust masks
• Ear protection
• Bicycle helmets
• Climbing helmets
• Construction hard hats
• High visibility safety vests

Step 1: Identify PPE Regulation Requirements

The first step of the process is to identify whether your product is subject to the PPE regulation. It covers all products defined as Personal Protective Equipment:

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‘personal protective equipment’ (PPE) means:

(a) equipment designed and manufactured to be worn or held by a person for protection against one or more risks to that person’s health or safety;

(b) interchangeable components for equipment referred to in point (a) which are essential for its protective function;

(c) connexion systems for equipment referred to in point (a) that are not held or worn by a person, that are designed to connect that equipment to an external device or to a reliable anchorage point, that are not designed to be permanently fixed and that do not require fastening works before use;

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Once this is established, you must then determine which PPE category your product belongs to.

PPE Category I, II and III

The PPE category determines the applicable conformity assessment process. The appropriate PPE category depends on the risk level and determines the conformity assessment process.

Category	Scope	Conformity Assessment Process	Notified body
PPE Category I	Products that protect from minimal risks such as: Superficial injury Contact with cleaning materials that have a weak action Damage to the yes (due to sunlight)	You must apply the Internal production control (module A)	Not required
PPE Category II	Products that protect from risks that are not listed under Category I or III (see Annex I for the full list	You must apply the following procedures: a. EU type-examination (module B), and b. Conformity to type based on internal production control (module C)	Required
PPE Category III	Products that protect from serious risks such as: Harmful biological agents Electrical shock Drowning Radiations Harmful noise Height falling	You must apply the following procedures: a. EU type-examination (module B) and either: b1. Conformity to type based on internal production control plus supervised product checks at random intervals (module C2), or b2. Conformity to type based on quality assurance of the production process (module D)	Required

Conformity Assessment Process

The conformity assessment procedure decides whether you need to get your PPE product certified by a notified body. This is the case for PPE

Step 2: Find relevant PPE standards

Now that you have determined that the PPE regulation applies and which PPE category your product belongs to, it’s time to identify applicable harmonised standards.

Harmonised standards provide technical specifications detailing how certain products can comply with the overall safety requirements of the PPE regulation.

Here are some examples of such standards for PPE. Note that the full list of harmonised PPE standards can be found on the European Commission website.

Examples

EN 142 – Respiratory protective devices – Mouthpiece assemblies – Requirements, testing, marking

EN 207 – Personal eye-protection equipment – Filters and eyeprotectors against laser radiation (laser eyeprotectors)

EN 343 – Protective clothing – Protection against rain

EN 352-1 – Hearing protectors – General requirements – Part 1: Earmuffs

EN 353-1 – Personal fall protection equipment – Guided type fall arresters including an anchor line – Part 1: Guided type fall arresters including a rigid anchor line

EN 388: – Protective gloves against mechanical risks

EN 397 – Industrial safety helmets

EN 564 – Mountaineering equipment – Accessory cords – Safety requirements and test methods

EN 1077 – Helmets for alpine skiers and snowboarders

EN 1497 – Personal fall protection equipment – Rescue harnesses

EN ISO 12312-1 – Eye and face protection – Sunglasses and related Eeyewear – Part 1: Sunglasses for general use (ISO 12312-1:2013)

EN ISO 12402-2 – Personal flotation devices – Part 2: Lifejackets, performance level 275 – Safety requirements (ISO 12402-2:2020)

Design for compliance

Regardless of the PPE category, testing is necessary to verify compliance with applicable standards. This requires that your product is technically compliant. This can, in practice, mean that you must ensure that your product is designed to meet certain physical or mechanical requirements.

Step 3: Create PPE label files

The PPE regulation mandates various labelling requirements, in addition to the CE marking requirements.

CE mark

The CE mark must be affixed to the product, packaging, or accompanying documentation.

Traceability information

The following information must normally be included:

• Product name/model
• Batch or serial number
• Manufacturer name
• Manufacturer address
• Importer name (if any)
• Importer address (if any)
• Authorised representative name (if any)
• Authorised representative address (if any)

Warnings and instructions

PPE must also be accompanied by detailed information and instructions. These can be found in Annex II of the regulation and may also be printed in an accompanying document. In this guide, these requirements are covered in step 5.

Step 4: PPE testing

Testing is necessary to verify compliance with applicable harmonised standards. The standard procedure is to submit PPE samples to a testing company.

Examples

• TUV Rheinland
• Eurofins
• Bureau Veritas
• SGS
• Intertek

Testing cost

The testing cost can range from a hundred to several thousand euros, depending on the PPE type.

Test report

If your PPE pass the test, you will obtain a test report. This test report demonstrates that your product is compliant with the listed standards. It must also be included in your technical documentation in step 5.

Notified Body

If your PPE product belongs to Category II or III, then you must also submit these to a Notified Body.

Step 5: Create documentation

The following documentation must be either created or obtained.

EU Declaration of Conformity

An EU Declaration of Conformity must be created by the manufacturer. The following information must generally be included:

• PPE product name, model, and batch number format
• Manufacturer information
• Authorised representative information (if any)
• Compliance statement
• Product image
• List of applicable EU regulations and directives
• List of applied harmonised standards
• Notified body information
• Conformity assessment process
• Name and signature

The Declaration of Conformity must be supported by a test report. Further, it must be maintained and made available for 10 years if requested.

Technical Documentation

The manufacturer must create a set of technical documentation, which normally includes the following:

• Complete description of the PPE and its intended use
• Assessment of risks against which the PPE protects
• List of essential health and safety requirements applicable to the PPE
• Design and manufacturing drawings and schemes of the PPE and its components
• Descriptions and explanations for understanding the drawings and schemes
• References to harmonised standards applied to the design and manufacture
• Descriptions of other technical specifications, if harmonised standards are partially applied
• Results of design calculations, inspections, and examinations
• Reports on tests to verify conformity with health and safety requirements
• Description of the means used to ensure conformity during production
• Copy of the manufacturer’s instructions and information
• Instructions for manufacturing PPE for individual users based on the approved model
• Measures to ensure compliance during the fitting and production of series-produced PPE

Manufacturer instructions

The PPE must also be accompanied by instructions explaining, among other things, what the PPE is meant to protect against. The following is listed in 1.4 under Annex II:

• Storage instructions
• Use instructions
• Cleaning instructions
• Maintenance instructions
• Servicing instructions
• Disinfection instructions
• Performance during technical tests
• Accessories that may be used
• Characteristics of spare parts
• Classes of protection for different risk levels
• Corresponding limits of use
• Month and year/period of obsolescence
• Type of packaging suitable for transport
• Significance of markings
• Risk against which the PPE is designed to protect
• Reference to the Regulation and other Union harmonisation legislation
• Name, address, and identification number of the notified body/bodies
• References to relevant harmonised standards or technical specifications used
• Internet address for the EU declaration of conformity

EC-Type Examination Certificate

Before you can sell PPE category II and III, you must obtain an EC-Type Examination Certificate from a Notified Body. This is, in turn, based on a review of your documentation and labels.

The exact information in the EC-Type Examination Certificate is provided in Annex V. That said, this document is issued by the Notified Body, and they are fully aware of what to include in it.