Machinery

Operator’s obligations

Responsibility for the conformity of the machine lies primarily with the manufacturer of the machine. Legislation also lays down certain obligations for the machinery’s importer and distributor. The manufacturer can authorise a representative to carry out certain obligations on its behalf.

According to EU legislation, an economic operator importing machinery to Finland can be either an importer (importing a device from outside the EU, i.e. a third country) or a distributor (importing a device from the EU market). You can find more information on the obligations of economic operators on the Tukes website.

Machinery’s manufacturer

Manufacturer refers to any natural or legal person who manufactures a product or has a product designed or manufactured, and who markets that product under their name or trademark. The manufacturer is responsible for ensuring that the machinery is safe and compliant. The manufacturer must carry out all the conformity assessment procedures relating to the machinery, draw up the required documents and affix the necessary markings to it.

Manufacturer’s authorised representative

The machinery’s manufacturer may, if it sees fit, authorise a party established in the EU to bear all or part of the obligations that fall on the manufacturer. The authorisation must be granted in writing, and it must specify the obligations the manufacturer mandates the representative to carry.

The manufacturer of the machinery can give all or part of the following tasks to the authorised representative:

• ensure that the machinery complies with the relevant essential health and safety requirements
• ensure that the technical file for the machinery is available
• ensure that the machinery is accompanied by appropriate instructions
• carry out the appropriate conformity assessment procedure
• draw up and sign the EC declaration of conformity
• affix the CE marking to the machinery.

Machinery’s importer

The importer of the machinery means a party who imports machinery from outside the European Economic Area to the EU market with a view to selling, for example.

The importer of the machinery must:

• ensure that the manufacturer has carried out the appropriate conformity assessment procedure for the machinery
• ensure that the manufacturer has prepared the technical file for the machinery
• ensure that the CE marking is affixed to the machinery
• ensure that the machinery is accompanied by the EC declaration of conformity and appropriate instructions, which in Finland must be in Finnish and Swedish as well
• where appropriate, co-operate with the national market surveillance authority.

Machinery’s distributor

For example, the distributor of the machinery means a party who sells machinery that is manufactured in the European Economic Area or previously imported to the Economic Area.

The distributor of the machinery must:

• ensure that the CE marking is affixed to the machinery
• ensure that the machinery is accompanied by the EC declaration of conformity and appropriate instructions, which in Finland must be in Finnish and Swedish
• where appropriate, co-operate with the national market surveillance authority.

Private label

In certain situations, the manufacturer’s obligations can be transferred to an operator which would otherwise be the importer or distributor of the machinery.

Private label refers to a product that an operator markets under its name or trademark, even if the product was originally manufactured by another operator. Sometimes such an operator calls itself the “commissioner”. However, from a legal perspective, the operator is the manufacturer of the product in this situation.

The importer or distributor is considered the machinery’s manufacturer when

• the importer or distributor places the machinery on the market under its own name or  trademark
• the importer or distributor alters the machinery that has already been placed on the market in a manner that may affect the compliance of the product.

As the operator is the product’s manufacturer, it is subject to all the manufacturer’s responsibilities. The operator cannot delegate responsibility for the conformity of the product. Instead, it must be familiar with the product’s characteristics and manufacturing process, as well as own the documentation that demonstrates the conformity of the product. This means that the operator must draw up an EC declaration of conformity for the machinery under its own name, and in the case of an EC-type examined machine, the operator must have an EC-type examination certificate issued for the machine itself.

Online store

Remote sales is a trade in which the buyer and the seller are not simultaneously present. Online stores are typical examples of remote sales. The product’s delivery method is not relevant in remote sales. It is also considered remote sales even if the product is picked up from the store, if the actual purchase contract is made remotely. Remote sales have exceptions in comparison to normal trading. You can find more information on the rules of remote sales, such as advance information, on the website of the Finnish Competition and Consumer Authority.

The statutory requirements for machinery are the same, regardless of where they are sold. However, in an online store, a device and its packaging are not physically viewable, so online store sellers must provide information relevant to the safe use of the equipment when it is sold. A device can be considered dangerous or non-compliant based on the information provided in the online store alone if the information provided is incorrect, or if the advertising is non-compliant.

You should acknowledge the following matters at least:

The online store must provide information relevant to safety and/or purchasing decisions. Consumers must be able to determine whether they can use the machine safely.

The information provided on the product must not be misleading (e.g. an electric vehicle is sold for off-road use, although it is not suitable for it in reality).

The information to be provided includes:

• Warnings
• Restrictions related to the conditions of use (e.g. for indoor or outdoor use only)
• Restrictions on use or deployment
• Restrictions related to premises (e.g. adequate ventilation)
• Suitable alternative energy (e.g. electric supply voltage and frequency, nominal power)

Product’s non-conformity

All economic operators, manufacturers, importers and sellers are responsible for the conformity of the machinery. Placing equipment on the market does not require inspection or approval by the surveillance authorities. However, a market surveillance authority may assess the conformity of the equipment placed on the market by testing it or requesting an economic operator to provide it with the EC declaration of conformity, technical documentation, or other information, for example.

If the operator suspects that the machinery it has placed on the market is not in conformity with the requirements, it must immediately take steps to bring the equipment into conformity, withdraw it from the market, or arrange a recall when necessary. If the properties of a device pose a risk to safety, health or the environment, the operator must immediately contact the authorities of the member states in which the product has been on the market, giving details on the non-compliance and of any corrective measures taken.