The EU Declaration of Conformity is a document, in which the manufacturer declares that the product conforms to the requirements.
The EU declaration of conformity is a document used by the manufacturer of a product to declare that the product is in conformity. The manufacturer prepares and signs the EU declaration of conformity before placing the PPE on the market. With the EU declaration of conformity, the manufacturer declares that the product fulfils all the applicable requirements. The manufacturer’s declaration of conformity lists all of the directives and regulations with requirements that the product fulfils.
The manufacturer can appoint an authorised representative to prepare the EU declaration of conformity on the manufacturer’s behalf.
The manufacturer or authorised representative draws up one EU Declaration of Conformity for the product, and the information listed below is recorded in it. Based on the information, the market surveillance authority can check which regulations and standards have been followed in the design and manufacture of the product. If several EU regulations that require an EU Declaration of Conformity apply to the product, one single EU Declaration of Conformity can be drawn up for all regulations. The EU declaration of conformity can also be a document that consists of all of the individual manufacturer’s declarations of conformity that apply to the product.
The EU declaration of conformity must include at least the following information:
- a description and identification data of the PPE, such as its product, type, lot or serial number. You can also attach a photograph of the PPE.
- the name and address of the manufacturer
- if necessary, the name and address of the authorised representative established within the EU
- a clause stating that the EU Declaration of Conformity has been prepared under the sole responsibility of the manufacturer
- reference to all applicable EU legislation
- a detailed reference to all relevant harmonised standards applied or to specifications based on which the EU declaration of conformity has been prepared
- if necessary, the name and number of the notified body that performed the EU-type examination and a reference to the certificate or decision issued by the notified body
- if necessary, information on the notified body under whose supervision the quality control during production is carried out
- The date when the EU Declaration of Conformity was issued
- The identifying information and signature of the person authorised to represent the manufacturer or his authorised representative.
The EU declaration of conformity must be structured as the model in Annex IX to the PPE Regulation (EU) 2016/425.
The EU Declaration of Conformity must accompany the PPE or, alternatively, the manufacturer must include the following information in the instructions:
- references to the PPE Regulation (EU) 2016/425 and other EU legislation where appropriate
- details of the notified bodies involved in the conformity assessment
- references to the relevant harmonised standards
- the internet address where the EU declaration of conformity can be accessed.
Language requirements on the manufacturer’s declaration of conformity
The EU declaration of conformity of a PPE placed on the Finnish market must be prepared in Finnish and Swedish.
- Check that the document is titled EU declaration of conformity. Documents with titles such as “Certificate of conformity” or “Certificate of compliance” are not documents required by the PPE Regulation.
- Check that the EU declaration of conformity follows the structure in Annex IX of the PPE Regulation.
- Check that the manufacturer’s name and address listed in the EU declaration of conformity are identical to those in the EU-type examination certificate.
- Check that the product named in the EU declaration of conformity (product, type, batch or serial number) is identical to that in the EU-type examination certificate, and that the information matches those found on the product.
- Check that the date of the EU declaration of conformity is on or after the date of issuing the EU-type examination certificate.
- Check that the notified body referred to in the EU declaration of conformity is the same body that issued the EU-type examination certificate.
- Check that the declaration is signed.