Personal protective equipment

Personal protective equipment is considered to be equipment designed and manufactured to be worn or held by a person to protect them against one or more risks to their health or safety.

On the safety of personal protective equipment:

  • Regulation (EU) 2016/425 of the European Parliament and the Council repealing Council Directive 89/686/EEC (applied in full from 21.04.2018 and is directly applicable).

  • Different standards (depending on the product group). You can find the standards on the website of the Estonian Standards and Accreditation Centre

Compliant personal protective equipment:

  • Have undergone a conformity assessment (for PPE in hazard categories II and III, the involvement of a third party, i.e., a notified body, is required) and has the relevant documentation;
  • Have technical documentation and an EU declaration of conformity. The technical documentation contains all the information on the product throughout its life cycle – from the product's design (drawings and description) to the materials used, the stages of production, the tests carried out, and the results, to how complaints are handled. The conformity declaration is the manufacturer's declaration of conformity of a product and can be found in Annex IX to Regulation 2016/425. 
  • Bear the CE conformity marking. The conformity marking must be affixed to each PPE item manufactured in such a way as to be visible and legible for the expected period of use of the PPE. However, where the product characteristics make this impossible, the conformity marking must be affixed to the packaging. The manufacturer or his authorized representative shall affix the CE marking before the personal protective equipment is placed on the market. In the case of personal protective equipment in risk category III, the CE marking must be followed by the identification number of the notified body;
  • Bear a type, batch or serial number or other indication allowing the product to be identified or, where the size or nature of the personal protective equipment does not allow it, manufacturers shall ensure that the required information is provided on the packaging of the personal protective equipment or in a document accompanying it.
  • It is labeled with the manufacturer's name, the registered trade name or registered trademark, and the contact address. The information must be either on the personal protective equipment or, where this is not possible, on its packaging or a document accompanying the personal protective equipment; in the case of an imported product, the same information must be provided for the importer.
  • Personal protective equipment shall be accompanied by instructions and information in a language determined by the Member State concerned which consumers and other end-users easily understand;
  • An EU declaration of conformity accompanies each personal protective product. The instructions for use are accompanied by a reference to the Internet address where you can find the EU declaration of conformity.

 For further information

European Commission

Further information on personal protective equipment

European Commission (2)

Notified authorities

Last updated: 06.04.2021