PPE (CE) Certification

The PPE Regulation ((EU) 2016/425) governs equipment designed to protect a person against one or more health and safety risks. Products are divided into three categories by the severity of the risk they protect against, and this category determines the conformity-assessment route — Category I minimal risks, Category II intermediate risks, and Category III risks that may lead to death or irreversible harm to health.

• Manufacturers of work gloves, hard hats, safety glasses and safety footwear
• Manufacturers of respiratory protection and filters
• Manufacturers of fall-protection equipment (harnesses, ropes, anchors)
• Manufacturers of protective clothing and high-visibility garments
• Manufacturers of hearing protection and chemical-protection products

Mandatory for equipment within scope. In Category I, the manufacturer self-declares through internal production control. EU type examination (Module B) is mandatory in Category II. In Category III, notified-body involvement is additionally required at the production phase alongside EU type examination: either product verification (Module C2) or quality assurance (Module D) applies, which means annual surveillance.

• Scope, definitions and risk categories (Annex I)
• Essential health and safety requirements (Annex II): ergonomics, protection levels, innocuousness, comfort and efficiency
• Not being harmful to the user's health; compatibility of materials
• The effect of ageing, cleaning and maintenance on protection performance
• Additional requirements specific to particular risks: mechanical impact, static compression, falling, electricity, heat and flame, cold, radiation, noise, hazardous substances and infective agents, drowning
• User information and the content of the manufacturer's instructions
• Stating the training requirement for Category III products
• Marking and obsolescence-date information
• Conformity-assessment modules and their selection by category

1. 1Determining the LegislationIt is determined which EU legislation applies to the product. A product can fall within scope of more than one piece of legislation at the same time; all of them must be met.
2. 2Selecting the Conformity Assessment ModuleThe legislation determines the module to follow according to the product's risk class. The manufacturer self-declares under some modules, while a notified body is involved under others.
3. 3Testing Against Harmonised StandardsConformity with harmonised standards published in the EU Official Journal is demonstrated through testing; this provides a presumption of conformity with the legislation.
4. 4Risk Analysis and the Technical FileThe risk assessment, design calculations, test reports, instructions for use and sample labels are compiled in the technical file.
5. 5The EU Declaration of ConformityThe manufacturer or its EU-based authorised representative signs the declaration of conformity. Responsibility rests with the signatory of the declaration.
6. 6Affixing the CE MarkThe mark is affixed to the product in the form and size the legislation prescribes; the notified body's identification number is added if one is involved.
7. 7Retaining the Technical FileThe technical file is retained for the period the legislation sets from the product's placing on the market (10 years under most legislation) and presented to the competent authority on request.

The CE mark is not a certificate but the manufacturer's declaration of conformity, and it has no expiry. However, the declaration remains valid as long as the product and the legislation do not change: the technical file must be updated if the legislation or the harmonised standard is updated. Notified-body certificates (e.g. an EU Type-Examination Certificate) are subject to a validity period.

• The product description, model list and technical drawings
• Risk assessment
• The list of harmonised standards applied
• Test reports
• Instructions for use and warning labels (in the target market's language)
• A draft EU Declaration of Conformity
• The product description, the rationale for category determination, and the protection claim
• Design drawings, the materials list and technical specifications
• Harmonised standards applied (e.g. EN 166, EN 388, EN ISO 20345, EN 149, EN 361)
• Performance test reports
• The innocuousness assessment (for skin-contact materials)
• The user instructions and a sample of the product marking

There is no fixed list price; the cost is calculated based on the following variables and provided in writing in the quote.

• The number of pieces of legislation applicable to the product
• The conformity-assessment module — whether a notified body is involved
• The required test scope and number of samples
• The current state of the technical file
• Translation and documentation needs

A Notified Body under CE is registered in the European Commission's NANDO database for the relevant EU regulation and carries a four-digit identification number. Notified body authority is based on legislation and product scope; The authority granted for one regulation does not extend to another. Testing is within the scope of ISO/IEC 17025, product certification is within the scope of ISO/IEC 17065.

The scope under which this scheme can be offered varies according to your product and activity; it is confirmed in writing at the quote stage.

• CECPR
• CELifts
• CEMachinery Safety
• CELVD
• CEEMC
• CERED
• CEMDR
• CEIVDR