As explained in this article, there is a great difference between the duties of distributors and manufacturers. In a nutshell, the manufacturer is responsible for all the product aspects whereas the distributor only transfers the product without any change including the product name.
Regulation 305/2011 (CPR): An importer or distributor shall be considered a manufacturer for the purposes of this Regulation and shall be subject to the obligations of a manufacturer pursuant to Article 11, where he places a product on the market under his name or trademark (…)
Normally, it is beneficial to stay in the role of a distributor because, simply, everything is easier. If the product does not show the declared properties, the manufacturer is to blame. But, there are situations when the distributor intends to become a manufacturer deliberately. Most often, this happens when the distributor wants to change the product name and/or hide the manufacturer’s identification. Many people think it is easy – just change the info on the label and sometimes “forget” to mention the manufacturer’s identification. But, then the DoP and CE marking do not comply with the CPR with all the unpleasant legal consequences.
How difficult is it to become a manufacturer?
It is both easy and difficult. When you change the product name, you become a manufacturer instantly. The problem is then you must fulfill the manufacturer’s obligations, mainly:
- product assessment (testing)
- factory production control
- documentation to the product
- product labelling
The good news is that it is all feasible provided that there is good cooperation with the original manufacturer. Let’s look at it step by step:
Step 1 – product assessment (testing)
If there is no change in the product as such, the test reports can be re-issued with the new product name and the identification of the “new” manufacturer. When a Notified Body is involved (AVCP systems 1+, 1, 3), the re-issuance is to be done by them.
Step 2 – factory production control (FPC)
The “new” manufacturer cannot, naturally, run an FPC system. Therefore, he should check regularly his supplier’s place of manufacture. This should be covered by a contract between the “new” manufacturer and the actual manufacturer. If a Notified Body is involved, the situation is not so easy, yet still feasible. Normally, a tripartite agreement is concluded. The contract says the actual manufacturing place will be audited and the result of the inspection will be transferred to the “new” manufacturer.
Step 3 – certification
If the previous points are dealt with correctly, certification is just a formal step. The actual process depends on the AVCP system but the idea is always the same – the findings made on the original manufacturer’s product/FPC can be transferred to the “new” manufacturer.
Step 4 – documentation to the product
The “new” manufacturer must supply the complete documentation depending on the product nature. Typically, it is a Declaration of Performance, a technical data sheet, a safety data sheet, a manual etc. (And not to forget promotional materials.)
Step 5 – product labelling
Correct packaging and labelling are also important parts of the manufacturer’s responsibility. The package must show all the required information – from CE marking to symbols of hazards. Typically, this is solved by the original manufacturer, but special care is advised here.
The change of the product name by a distributor brings the necessity to become formally a manufacturer of the product. However, it is not so difficult provided that there is good cooperation with the actual manufacturer. The process described is relevant for products falling under CPR. National certification schemes can have different conditions.