Regulation on personal protective equipment correctly applied: These requirements result for your CE-compliant product

The PPE Regulation (EU) 2016/425 replaces the PPE Directive 89/686/EEC on personal protective equipment of June 1995. It contains guidelines and regulations for all personal protective equipment, which are brought to the European market. The regulation ensures the protection of public health, improves safety at work and guarantees the protection of users.

The Directive and Regulation define personal protective equipment (PPE) as equipment that a person carries to protect against one or more health and safety risks. Their scope thus includes a variety of devices and equipment.

The directive and regulation parts PPE in 3 product categories. In the Regulation, they are classified according to the degree of risk. Category I includes simple low-risk products and Category III complex products for work that can cause serious health damage. Depending on the category, the Directive and the standard define different standards for compliance with the regulations with specific requirements for certain types and uses of devices. Learn more about the categories below.

Category I includes simple products intended mainly for private or non-specialized use. Examples of category I items: garden gloves, sunglasses or ski goggles.

Category II is a collective term that refers to products that do not belong to category I or III. The products in this category can range from items for personal use to items for professional use. Category II includes products such as hearing and visual protection devices, protective clothing and sportswear.

Category III comprises complex products intended primarily for professional or specialised use. This category includes, but is not limited to, products designed to protect against falls from altitude, electrical hazards or toxic/radioactive gases, such as respiratory or circulatory systems.

The following personal protective equipment is not covered by the PPE Directive and Regulation:

The CE conformity assessment procedures of the above PPE categories are similar. The manufacturer prepares (if necessary with the support of easyCE) the technical documents and documents, applies a CE marking and issues a CE declaration of conformity. In many cases of category II and III, manufacturers also require certification by a notified body. Category III products require product and production quality monitoring. easyCE will find a suitable notified body for you and establish the contact if necessary.

The CE mark is the manufacturer's statement that the product complies with the applicable EU safety, health and environmental requirements and that it complies with the relevant European standards (EN). The regulations also apply to systems made of personal protective equipment in conjunction with another external product.

The basic steps for CE certification are:

Notified bodies (BS) or Notified Bodies (NB) are independent persons or organisations qualified and approved to approve the affixing of a CE marking. If it is a product for which the Directive requires a notified body to verify it,

Depending on the product-specific safety requirements prescribed in the directive and the standards, tests are carried out by the manufacturer himself or by an external laboratory. The test procedure and the detailed results are documented, checked by the notified body and included in the technical documentation of the product. easyCE will be happy to determine which tests are required for your specific product.

As part of the risk assessment, the possible hazards arising from the product or its misuse are analyzed and evaluated. A risk management report lists the derived measures to minimize the risks. Evaluation and report are part of the technical documentation. An easyCE expert will be happy to look at your product or prototype on site, record data in (online) meetings or receive your product by post to carry out the risk assessment for you.

Which documents are part of the technical documentation (also called dossier) is defined in the relevant EC directives. The documentation contains all the documents required to meet the security requirements. This includes information on the design, manufacture and use of the product, such as:

Technical documentation must be retained even after the last product has been sold. The period is usually 10 years, but can also be 5 years depending on the product. The technical documentation must be made available to the public and national market authorities without delay upon request. If the documentation is incomplete, the manufacturer has 14 days to submit the missing documents.

When the documentation is completed, the manufacturer must officially declare that the product meets all relevant safety requirements. For this purpose, the manufacturer prepares a declaration of conformity. The person responsible for monitoring the CE marking must sign the document. easyCE is happy to support you in the preparation of a CE declaration of conformity. If the product is manufactured abroad, the importer is responsible for CE conformity. The latter has the right to issue and sign the declaration of conformity.

A declaration of conformity contains the following elements:

The following labelling requirements apply: