Manufacturer vs. Legal Claimed Manufacturer -- MEDICA - World Forum for Medicine


Obelis O.E.A.R.C.

Manufacturer vs. Legal Claimed Manufacturer

By European Directive & Regulations, the manufacturer is responsible for the design, manufacturing, packaging and sale of a product placed on the European market under his own name whether he is actually fulfilling those tasks or subcontracting them.

European regulation categorizes entities placing products on the market under their name into two main categories: manufacturers and legal claimed manufacturers.

There are several ways in which these two entities are similar:

Both have the ultimate goal of introducing their products onto the European market.
Both own their respective brand and place them on the market under their name.
Both are equally responsible to the conformity of the products they are placing on the market under their name (towards the European users and the European Authorities).
The main difference between the manufacturer and the legal claimed manufacturer is the process by which they obtain their products – one is actually manufacturing his product (the manufacturer) while the other obtains an already manufactured product and rebrands it (the Legal Claimed Manufacturer);

If an entity actually produces the product and owns the manufacturing process by which it was created, then by definition, he is the manufacturer. He then takes the product, which he produced, and sells it on the European market under his brand name.

In contrast, if an entity does not actually manufacture the product, rather buys it from a third-party (also known as “producer” as he actually produces the product), then he is defined as the legal claimed manufacturer. The producer’s purpose is only to sell its products to the legal claimed manufacturer, not directly to the European market. The legal claimed manufacturer then takes complete ownership and responsibility of the product and sells it in the EU under his brand name.

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