Do you also know that it’s immensely important for a manufacture located outside the European Economic Area (EEA) to appoint a responsible party owing the Technical File for the purpose of CE marking? But who is a responsible party?
A responsible third party can be:
- The manufacturer
- The importer
- The distributor
- The Authorized Representative
What happens if the manufacturer is not located within the European Community and if he has not appointed a third party such as an Authorized Representative in Europe? Then the person who is placing the products out in the market, which is the importer, is responsible for presenting a Declaration of Conformity and the Technical File to the surveillance bodies.
There are a lot of responsibilities that all the parties mentioned above should fulfil. Let us now take a look at the how, why, what, and where of this.
Responsibilities of the manufacturer
You are a manufacturer if you manufacture the products yourself or have them designed/manufactured from another place.
- If you place the products on the market under your name or trademark, then you’re the manufacturer.
- If you assemble, pack, process or label ready-made products and place them on the market under your own name or trademark, then you’re the manufacturer.
- If you change the intended use of a product, substantially modified, or further re-built a product, in such a way that other legal requirements for CE marking will become applicable on the new transformed product, then you’re the manufacturer.
Now that we are through with the various definitions, it’s time to learn about the responsibilities, a manufacturer has to complete. The manufacturer is responsible for designing, manufacturing and carrying out the essential conformity assessment in accordance with the procedure(s) laid down by the Union harmonisation legislation. As mentioned above, even if you’re modifying a product, then you’re required to undertake all the obligations just like a manufacturer and must ensure the compliance with the applicable European Union harmonisation regulations so that the necessary conformity assessment procedure can be carried out.
Role and responsibilities of the Authorized Representative
Whether or not you’re located within the European Community, you still hold the power to appoint an Authorized Representative to act on your behalf for the execution of certain tasks established in the CE-marking Directives. The Authorized Representative can also be an importer or a distributor in the meaning of Union harmonisation regulations.
Commercial representatives ARE NOT the Authorized Representative, and the latter must be established inside the European Union. After an official contract has been put in place for the legal Authorized Representative, they have the access to the Technical File and EC declaration of conformity so that they can duly co-operate with national surveillance bodies or competent national authorities.
Role and responsibilities of the importer
The importer has a restricted but clearly described responsibility under the EU rules and regulations if he/she is not from the country situated in the European Union. Placing the products out there on the market is not the only mere responsibility of a reseller. They must ensure that the manufacturer has drawn up the technical documentation and carried out appropriate conformity assessment procedure.
The importer carries more power than the Authorized Representative so that the essentials commands can be made via the importer to the manufacturer to fulfil the neglected needs. It is important for the importer to check the valuable CE marking stamp and printing of the safety information in a language where the product is being put into use including the point of contact.
In case the competent authorities would like to see the technical documentation, it should be made readily available. If the importer is liable to act as a manufacturer, then it’s significant to ensure that the product meets the essential requirements in accordance with the applicable Directive(s).
Role and responsibilities of the Distributor
Distributors are the wholesalers, retailers and other merchants that make the products available in the market. A distributor acquires products for further distribution either from a manufacturer, from an importer, or from another distributor and does not need to have an exclusive relationship with the manufacturer like the Authorized Representative or an importer.
They are required to remember and identify the manufacturer, his authorised representative, the importer or the person who has provided him with the product. It is an obligation for the distributor to have the knowledge of CE-marking regulations and other EU rules and regulations for the products. They are also expected to compile a contract satisfying the conditions of the European regulations.
Certification Experts service and support
We are aware that it’s highly impossible for the manufacturers, producers, importers and designers to carefully and adequately accomplish all the necessities for CE marking. That’s when we enter to act as an Authorized Representative.
We at Certification Experts perform the entire certification process and ensure that your products meet the specified European safety requirements.
For questions about your responsibility regarding CE-marking or other questions, please contact us today.