The EU harmonization legislation shall provide a base for elimination of barriers and on free movement of goods inside the EU. Plaucon supports you in CE marking for your product.
To place a product on the European market, it must fulfill the applicable European legislative acts for the product. Some of these acts demand a CE-marking.
To achieve the presumption of conformity with the legislative acts, harmonized standards shall be considered. These standards are published in the Official Journal of the EU.
Requirements for technical documentation arise depending on the regulation that must be complied with. I support you in the preparation of the technical documentation – a one-stop service.
The risk analysis considers all hazards and risks associated with a product. This involves examining harmonised standards and the state of the art for the product.
Technical files are intended to demonstrate compliance with the safety requirements for the product. They are therefore of great importance when placing products on the market.
The instructions manual is intended to ensure the safe use of the product for the customer. This document must be comprehensible, clear and complete.
The DoC is the ‘passport’ for free movement within the EU. It must show conformity with the applicable regulations and has a precisely defined structure.
Risk analysis is of central importance when placing products on the European market.
The risk for the user is assessed by identifying hazards that may emanate from the product. A wide variety of hazards can be assumed: mechanical hazards, thermal hazards, electrical hazards, etc.
The role of the risk analysis is to identify these hazards at an early stage and minimize the risks associated with these hazards.
I support you in preparing the risk analysis and thus the next step towards successful CE marking.
Products shall be accompanied by safety instructions to avoid risks associated with the product. Safety instructions must be clear and easy to understand. It is important that the safety instructions are selected in such a way that they are uniform and comprehensible.
Detailed instruction manuals shall warn of dangers and enable safe use of the product. There is a minimum requirement for the content to be included in the instruction manual.
With Plaucon you can be sure that the safety instructions are comprehensive and the instruction manual is compliant.
The DoC is the “passport” for products within the EU. If a product has been successfully placed on the market in one EU country, it has the right to be marketed in another EU country. An obligation for the manufacturer is to draw up and sign an EU Declaration of Conformity before placing a product on the market.
There are precise specifications as to what must be on a DoC. And this is where the harmonized standards come into play. Harmonized standards trigger the presumption of conformity in a DoC. They are an important tool for confirming CE conformity.
You are not sure how a CE process works and you would like to bring your product onto the EU market safely and in compliance with the law. I will answer the questions that are currently on your mind.
The CE mark is for the free movement of goods within the EU. This indicates that the product complies with the health and safety objectives of the EU regulations that require CE marking and can be used safely.
However, there are also regulations that require a different marking than the CE marking. These include, for example, the WEEE Directive – waste of electrical and electronic equipment or the ATEX Directive for equipment in potentially explosive atmospheres. This additional labelling must be applied depending on the product and application.
A declaration of conformity is only issued for products where this is required by EU legislative laws. In such cases, however, it is legally binding. The declaration of conformity must accompany the product and differs slightly in its requirements depending on which EU directive/regulation applies. Detailed specifications on the content can be found in the applicable directives/regulations.
This in turn depends on your product and the application. In the Machinery Directive, for example, there are so-called ‘particularly dangerous products’. In this case, an external body must be consulted to confirm compliance with the Machinery Directive. In the same way, external bodies must also be consulted for compliance with the Battery Regulation.
When and for which product an external body must be consulted can be found in the relevant directive/regulation.
The CE marking is required by European legislative laws to show compliance with the safety and health objectives for the product.
It therefore only applies within the EU. If you want to export to third countries, the market requirements of the third countries apply. The CE mark is therefore not valid outside the EU.
However, there are mutual agreements between the EU and other countries to accept the CE marking there.
The European legislative laws for products provide very clear guidelines for economic operators. These are summarised under the term ‘new legislative framework’.
First and foremost, the manufacturer is the one who claims to be the manufacturer. This means that his data is shown on the product. By labeling the product in his name he automatically becomes the manufacturer.
When importing a product on the european market the importer must be identified on the product, besides the manufacturer.
Placing your product on the market. Opportunities are there to be seized. Take the chance and contact me for a free 20-minute initial consultation.
+48 789 480 037
jan.kratky@plaucon.com
I offer you a free 20-minute initial consultation. During this initial consultation I would like to discuss your product and give you valuable advice. And I would be delighted if we could go down the path of product compliance together.
