The manufacturer definition in CE legislation can lead time to confusion. In this article we will try to inform about who the manufacturer according to CE legislation and their responsibilities.
Who is a manufacturer?
The manufacturer is any real or legal entity responsible for designing or manufacturing a product and marketing with its own name or trademark. Therefore, if the product is marketed under the name or trademark, then the person will be considered as a manufacturer.
Who is Responsible for Manufacturing?
In addition to those who produce the product itself, any real or legal entity that combines, packs, processes or labels ready-made products and markets them with its own name or trademark is also considered the manufacturer.
In addition, any person who changes a product in order to significantly change or regenerate the purpose of use of a product in order to drive or put it into the market, is also considered the manufacturer.
The Status of Subcontractors
Producers can design or manufacture subcontractors to market under their name or trademark. The packaging, labeling of products can also be made into subcontractors. However, the responsibility of the manufacturer cannot be undertaken by subcontractors.
Status of Sub Contractor Manufacturers
In case of subcontractor, the manufacturer must have general control of the product. The manufacturer, which gives part or whole of its activities to the subcontractor, does not load its own responsibilities to the authorized representative, distributor, user or a subcontractor. There is only one and final responsibility to ensure that the product conforms to the relevant legislation.
What Are the Responsibilities of Manufacturers?
The main responsibilities of the manufacturer are:
- To design and manufacture the product in accordance with the requirements and other legal requirements of the European Union legislation
- To make conformity assessment according to the procedures set by European Union legislations
It is responsible for understanding both the design and construction of the product. This applies to situations where the manufacturer uses subcontractors.
It is necessary to have relevant information to show the suitability of the product. In this context, it must have all the necessary documents and certificates to show the suitability of the product. However, they do not need to be under their own name. (For example, parts and staff certificates)
Is it difficult to become a producer’s address from the European Union Countries?
The European Union legislation does not require the manufacturer to be installed in the European Union. For this reason, when a product is presented to the European Union market, the responsibility of the manufacturer is the same, regardless of whether it is established in the European Union or in a Member State.
What should I do?
As a general rule, the manufacturer should take all necessary measures to ensure the suitability of the following subjects:
- The relevant European Union should take or build the conformity assessment prescribed in compliance legislation. Depending on the compliance rules of the relevant European Union, the manufacturer may need to submit the product to a third party (usually an notified body) in order to perform conformity assessment or have a approved quality system. In any case, the manufacturer carries all the responsibility for the suitability of the product.
- The required technical file should be prepared.
- EU Declaration of Conformity should be prepared.
- In the way the product requires the relevant European Union legislation, users should provide easily understood instructions and security information. These should be in a language set by countries.
- This product must contain all of the information on the installation, installation, processing, storage, preservation and disposal of the product necessary for safe use by the consumer.
- Installation or installation instructions should include special capabilities or tools with inventory parts.
- Instructions for operation should include information on use restriction, personal protective equipment necessity, maintenance, cleaning and repair.
- The determination of information to be included in the instructions and security information for a specific product is the obligation of the manufacturer.
- The producers look beyond what they think while determining the purpose of the use of a product and they think that they will use it in the position of the average user of the product. In addition, this possibility should be taken into consideration in the design and instructions that accompany the product by considering that a tool intended only for professionals and can also be used by non-professionals intended to be used by them;
- Below, the manufacturer should meet the requirements of the traceability included:
- After product supply to the market 10 retains technical documents and EU declaration of conformity until the time specified in the compliance action of the relevant European Union,
- Allows the product to carry a type, batch or serial number or another item that allows to identify,
- The following three elements relating to their own indicate the products in the packaging and/or attached documents if the product is not possible due to the size or physical properties of the product:
- Name
- Trademark or registered brand and
- A single mail address (This address is not necessary to be built in the Member State in the market of the product)
- Conformity mark (CE mark and other related markings) shall be discussed in accordance with the relevant legislation;
- Ensures that procedures are in force to remain compatible with the mass production. In order to maintain compliance in mass production, it is sure that the procedures are properly applied. Changes in the characteristics or design of the product and changes in the harmonised standards or other technical specifications of the product should be taken into account. It depends on whether the producer is important in terms of movement, the nature of the changes occurring in the harmonized standards or other technical conditions, especially if these changes are important in the scope of the basic or other legal requirements, and the changes are specifically interested in and not interested in. This may require the update of the EU Declaration of Conformity as an example, the replacement of product design, linking with notified body etc.
- Confirms the product and/or quality system in the relevant cases. In some cases, at the end of the production chain of the manufacturer may need to perform sample test or provide additional protection to consumers or other end users for marketed products.
What should be the producer who thinks that the product does not fit?
The manufacturers who think that the product is not suitable for CE legislation, or in this direction, must take appropriate corrective measures, such as making the product suitable, attracting from the market or calling back if necessary. This may also require a notification to competent authorities.
Market Surveillance and Inspection Unit Audits to be done by the authorities On a required request, the manufacturer must provide information and documents that may be required to show the suitability of a product to the competent national authorities in a language that can be easily understood by these authorities. In accordance with the request of the competent national authority, the producers must collaborate with the authority of any prevention taken to dispose of the risk of the product they supply to the market. The products related information should be presented for 10 years from the date they sell the product.
Liability of Persons Presenting the Product to Service
For products that are mainly manufactured to use in their own facility, the actual or legal person, which offers the product to service, has the same responsibility with the manufacturer that supplies a product to the market.
In addition, the person who supplies second hand products from a third country to the European Union market or is not designed or manufactured for the European Union market, is undertaken the role of the manufacturer.
Responsible for importers and distributors
If the importer or dispenser changes a product to the extent that the suitability of the relevant requirements can be affected or supplied under its own name or trademark, it is considered manufacturer.