What is a Declaration of Performance?
The EU Declaration of Performance (DoP) is a legal document, wherein a manufacturer formally declares the compliance of a product with the essential health, safety and environmental requirements of the relevant directives. By drawing up and then signing the EU Declaration of Conformity, the manufacturer assumes full responsibility for the product’s CE compliance. The DoP is drawn up only after the technical documentation (aka technical file) is compiled.
The Declaration of Conformity is mandatory for any product that falls within the scope of the CE marking legislation. In most cases, when a product is covered by several product safety directives, only a single DoP needs to be drawn up.
A copy of the Declaration of Conformity should be added to the technical file and made available upon request of the national market surveillance authorities. If the Declaration isn’t available or is invalid, the market authorities will recall the product, issue a monetary fine and the person who placed the product on the market could face imprisonment.
The Declaration of Conformity must be kept for ten years from the date of placing the last product on the market unless the relevant CE directives provide for any other duration.
The DoP must be drawn up in one of the official languages of the European Union. However, the CE directives don’t necessarily specify who has an obligation to translate it. Logically, this should be the person making the product available on the EU single market.
Contents of the Declaration of Conformity
Most CE directives and regulations have different requirements for the content of the Declaration of Conformity. However, the format and content of the Declaration of Conformity should follow a “model structure” to be easier to understand, especially if it’s in another language or alphabet. The DoP usually includes the following elements:
1.Name and business address of the product manufacturer or the authorised representative.
2.Identification that allows the product’s traceability. E.g. a serial or model number, or type identification.
3.Notified body details, if applicable.
4.A statement, saying that the manufacturer takes full responsibility for the product’s compliance.
5.A list of all applicable CE directives and regulations the product complies with.
6.A list of all EN harmonised standards or methods used for verifying the product’s compliance with the directives.
7.Name and signature of the manufacturer.
8.The place and date of issuing the DoP.
9.Any additional information.
Who can issue and sign a Declaration of Conformity?
The Declaration of Conformity can be issued and signed by the person that places the product on the European single market. In most cases, this person is the product’s manufacturer or importer.
When a product is imported into the EU/EEA from a non-EU country, the importer must make sure that the product complies with all legal product safety requirements. Moreover, the importer is also responsible for verifying that the technical file is correctly assembled and available.
Distributors don’t need to draw up the DoP but must verify that the manufacturer or importer has taken all legally required measures. However, if a distributor decides to rebrand or modify a product, they should take over the manufacturer’s responsibilities. Thus, draw up and sign a Declaration of Conformity.
The manufacturer’s EU authorised representative can also sign the DoP. The authorised representative must be based in the EU/EEA and be explicitly designated by the manufacturer in the non-EU country.
The declaration can never be issued by a Notified Body or a test house because they don’t have overall responsibility for the product’s compliance. They can only issue test certificates stating their opinion about limited conformity aspects.
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