Is it possible to get sample documents so that we can estimate the scope of the work?
We cannot provide you with sample documents because they were created for a specific customer and the customer has the sole right to dispose of them.We can’t give that away.
Is an EC test certificate required for our product, can this already be estimated?
All answers to these questions are part of our work and require some research. This can only be assessed in advance in rare cases.If you would like this evaluation of your products separately, please let us know.
Does easyCE update my documents if policies change?
When the EC/EU directives change, the directives usually state how to deal with the changes. Experience has shown that there is plenty of transitional period to be able to react to this. However, policy changes are rare, but shipments to the UK could become more problematic in the future. New standards are more likely, and they must be observed from publication in the Official Journal. Since you as the distributor have a product monitoring obligation, it is up to you to process changes to the legal bases, if they apply. We can help you.
Who is liable and who bears the risk of the licence holder acting as wholesaler or the seller selling to end customers?
The person whose name and address is stated on the type plate or in the declaration of conformity. on the market "provider" who initially bears the risk.
We have the following company structure: Producer GmbH, Client GmbH and Seller GmbH, which company must make the declaration of conformity?
All can be distributors. You determine who is the "place of sale" (place of sale: A legal person providing the products in the context of a commercial activity on the EU market). It is important that the person who places products on the market must also have all documents ready for 10 years. So, who has the manufacturing and testing documents.
How many products do easyCE offers apply to?
First of all for the products that have been agreed. If other products are very similar and do not involve extended hazards (which is determined in the risk assessment), then other products can be called "series". The offer would therefore also apply to these products.
What programs do you use to prepare the CE declaration of conformity? Could we later import the work you have done into the program if we also buy a program license?
You do not need to purchase a license, all our documents are in . docx Format created (MS Office) and also provided to you in this source format. With the assignment to us, you acquire the sole "right of disposal" of the data.
Can you briefly explain how the risk assessment process would work? What would you need from us?
In the course of the risk assessment, all expected/possible hazards in the life cycle of the product are determined on the basis of the requirements of the directives and regulations and the applicable, harmonized European standards (the EN). Furthermore, the possible extent of damage and the probability of occurrence are evaluated. In the next step, risk-reducing measures must be taken if necessary. If necessary, these can lead to constructive changes to the product, so that an acceptable level of residual risk is achieved.
Is easyCE liable for CE conformity? Who accepts CE conformity? Will it be sent to a testing centre?
1. We support the manufacturer or. the placing on the market in the measures for the provision of safe products on the European market, as "vicarious agents" according to 278 BGB.
2. The conformity of the product with the requirements of EC directives, standards and national laws (such as ProdSichG), etc. only the manufacturer or the authorised representative may declare the manufacturer’s representative in the course of a commercial activity.
3. An independent testing body does not have to be involved because it is responsible for the conformity of the manufacturer. Only if a directive requires an EC test certificate, a "notified body" must be commissioned with the conformity test. This verifier then issues an EC test certificate, which is not a declaration of conformity. The declaration of conformity can only be issued by the manufacturer, see point 2.
4. The result of the entire conformity assessment, that is, the documents produced must be stored for 10 years and submitted to the supervisory authority on request. The product must be accompanied by the declaration of conformity and instructions for use, and the remaining documents will remain with you.