Global Distribution – Electrical Equipment Compliance Responsibilities

We simply ship someone else’s product. It’s not our responsibility to make sure the product is in compliance.

This thought process comes up quite often when talking about electrical equipment and although there may be some truth to it, there is also a lot of misunderstanding between a distributor, a manufacturer and an Importer. Not having a clear understanding of what your company is classified as can cause undue risk and compliance gaps. Let’s start by reviewing a few definitions. The International Electrotechnical Commission (IEC) defines a Manufacturer as;

an organization that carries out the process of bringing a product to the market. This includes the manufacture, assessment, verification, handling and storage of a product. A Manufacturer has full responsibility for continued compliance of the product with the relevant requirements and undertakes all obligations in that connection. (1)

Some key statements here are “bringing a product to market” and “responsible for continued compliance”. This description doesn’t specifically say that the manufacturer is the party responsible for the construction of the product (we will discuss that next), but instead the company who brings the product to market. If we elaborate on that, you will also see references to “the Manufacturer” spread throughout the harmonized compliance standards. For this example, let’s review the IEC 61010-1 standard which is applicable to electrical equipment for measurement, control and laboratory use;

Clause:

5.1.2 Identification

The equipment shall, at a minimum, be marked with:

  1. the name or trade mark of the manufacturer or supplier;

5.4.1 Documentation General

The following documentation necessary for safety purposes….

c) name and address of the manufacturer or supplier from whom technical assistance may

be obtained; (2)

What we can gain from these references is that the Manufacturer’s name and address must be included on the products label (identification) and within the products documentation (Users Guide or similar). In short, the legal company name on the product label and within the products documentation (which should be consistent), is the party responsible for the compliance over the lifetime of the product. For additional clarification, the official journal of the European Union (C272/29) writes;

the economic operator that places the product on the market under its name or trademark becomes automatically the manufacturer for the purposes of Union harmonization legislation. Therefore, he takes the entire responsibility for the conformity assessment (design and production) of the product, even if this has been actually done by somebody else. Furthermore, he must be in the possession of all documentation and certificates necessary to demonstrate the conformity of the product, but these do not need to be under his name. (3)

The manufacturer who subcontracts some or all of his activities may in no circumstances discharge himself from his responsibilities, for example to an authorized representative, a distributor, a user or a subcontractor. (3)

Now that we have an idea of what a manufacturer is, and what they are responsible for, lets review one last definition by the IEC.  The definition of a Factory;

The factory is where the product is produced or assembled. This is also where the factory surveillance is established by National Certified Body (NCB) in the Certified Body (CB) Scheme and/or routine tests are performed by the factory.  (Authors note: Routine tests refer to dielectric and ground bond testing of a product before it leaves the factory floor bound for the customer. (1)

This definition clearly defines that a factory is where the product is physically assembled and where the inspection of said product takes place. If we contrast this against the definition of a manufacturer we can conclude that a Manufacturer can be a Factory, but a Factory cannot be a Manufacturer. Put differently, the location where the product is assembled does not always equate to be the manufacturer, but instead it’s the legal name labeled on the product that claims that designation.

You may be thinking, “What happens when my company does not put their name on the product (or the products documentation), and they don’t assemble the products either”? This is what some may call a Distributor. Unfortunately, the IEC does not really define what a Distributor is. The reason for this is because a Distributor can move products from EU territory to EU territory without compliance concern, but more specifically, it’s the act of moving goods into a new market that is regulated.  This action of introducing goods into a new market is referred to as Importation, thus making the company responsible for this action the Importer. Lets review some regulations around Importers;

For products imported from countries outside the EU, Union harmonization legislation envisages a special role for the importer. The latter assumes certain obligations which to some extent mirror the obligations of manufacturers based within the EU (3)

              This is where a lot of companies today fall short. Just because a company does not design the product, or physically build the product, they think their liability is low. Where in fact, if a company imports the product into a new market, they essentially take on the same liability as the manufacturer. Thus, if the product does not comply with regulations, the importer can be liable.

Other situations to consider is when an Importer of a product modifies either the product itself, or the products documentation to meet their own marketing needs. These modifications can directly affect the previous compliance evaluations and certifications. At a minimum, it could change the claimed legal owner of the product.

The importer now has clear obligations in relation to the compliance of products, and where a distributor or an importer modifies a product or markets it under their own name, they become the equivalent of the manufacturer and must take on the latter’s responsibilities in relation to the product.(3)

In conclusion, what does this all mean? There have been various terms discussed and numerous manufacturing situations reviewed, but simply put, a company who imports a product into a market holds the liability for the product as it relates to the necessary compliance regulations. A company can no longer hide under the limited scope of a “distributor”. The responsibilities and legal obligations of a manufacturer now apply to the importer as well. This means that before new products are purchased and resold, they must be extensively reviewed and verified for global compliance. If compliance gaps exist with electrical products, the importer is legally and financially responsible.

Sources & Literature (if any):

Author: Brett

Brett Gagnon is currently one of the global subject matter expert for electrical equipment and electrical medical devices at Merck KGaA Darmstadt Germany, otherwise known as Millipore Sigma within North America. He has an Electrical Engineering degree from Wentworth Institute of Technology and a Masters of Business from Southern New Hampshire University. Mr Gagnon has a background in the ATIC (Assurance Testing Inspection Certification) industry based on previous years working for Intertek Testing Services NA Inc out of the Boston Ma area. During his time at Intertek he became a CB certified engineer evaluating products to medical, laboratory, IT, and Industrial standards. He also has a knowledge base in laser, Ingress Protection testing and wireless radio registration. Additionally Mr. Gagnon was a Field label and Special Inspection agent reviewing large custom equipment for national safety approvals in North America.

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