Expertise
Over time CE marking Nordic AB has developed a broad-based consultancy practice. With regard to CE marking we do not restrict ourselves to a single EC Directive, but are familiar with all product groups.
CE marking is spreading further and further across the framework of trade and industry within the EU but also in other regions. New legislation and standards are being developed, many directives and regulations are being amended and from time to time EU rules are withdrawn. Through its network of partner companies and associations CE marking Nordic AB can keep a close eye on the developments, so that we always are able to provide you with the latest information.
Our consultants can provide advice on all EU directives and regulations for CE marking, such as for machines, stand-alone or production lines, medical devices, electrical equipment, construction products, movable bridges and locks, ATEX and pressure equipment.
Advice
CE marking can be a real headache for many firms. This may be due to the lack of in-house expertise or simply because of a lack of available time.
Our aim is to allow the CE marking process to progress as smoothly as possible and to ensure that the things that are of the greatest concern to you do not stagnate. In fact, it is frequently possible to speed them up.
We at CE marking Nordic AB can undertake some of the tasks for you, such as carrying out risk analyses, interpreting law texts and standards and writing instruction manuals.
Companies working on a cooperative project often have questions about how responsibilities should be shared, e.g. Who is responsible for the CE marking? Where should we store the documentation? We will help you to find the best answer to these questions.
CE marking Nordic AB is also often asked to evaluate new or modified production lines. The first step is to answer the questions whether CE marking is necessary and who is to be named as manufacturer.
If an external agency, such as a Notified Body, needs to be involved CE marking Nordic AB can guide and support you through the approval process.
CE marking Nordic AB can also be of assistance during the procurement process. It is by no means unusual for a supplier to have a different interpretation of the CE marking from the customer. In such cases CE marking Nordic AB can assist you in discussions regarding the application of the requirements.
Naturally our advice is set out clearly in our reports.
Risk analysis
One element of CE marking is the analysis of any risks inherent in the use of a product. In some cases it is sufficient to apply certain standards, but it is frequently necessary to undertake a risk analysis for the product. Since the risk analysis or the use of standards frequently have a direct influence on the design of a product, these procedures should start at the earliest possible stage.
The risk analysis relates to any hazards inherent in the presence and the use of the product. Once these have been identified an appropriate method can be used to estimate the level of risk. This can then be used to identify solutions which allow the risks to be reduced to an acceptable level. It is important here to use as a guide the requirements in the relevant EU directives and EU regulations. If it is not feasible to modify the design, measures will have to be prescribed to ensure safety by means of a guard, protection, a warning system or the use of personal protective equipment.
There is no single method of risk analysis that will produce the best results in all cases. In applying a method there is always a strong personal element as it is usually a matter of expressing a feeling in useful figures, where there is rarely an absolute truth. It is therefore important for the method to be suited to the person who will be carrying out the analysis. Secondly, it must be possible for the results to be directly applicable in practice. Thus the individual concerned will have to be acquainted with the analysis and then generate practical solutions.
For machines and all products that entail similar hazards the method used frequently expresses the risk as a function of injury or damage, amount or frequency of time spent in the danger area, the likelihood of the dangerous event and the degree to which the repercussions can be prevented.
Documentation and information
Working with CE marking produces a range of documents relating to the product, which can be stored in a binder or digitally. This so-called technical documentation does not always need to be permanently available and the period for which this file must be kept may vary for different products. This file must be available for consultation by an inspector where there is any doubt about the correct implementation of the CE marking.
The technical documentation contains the results of the risk analysis and the implementation of standards, the instruction manual, the implementation of the directives and regulations etc. and is intended to provide evidence that the requirements for CE marking have been met. It can be seen as a sort of insurance policy as it is very rarely used for this purpose. However, it is beneficial in other ways, in that it is a structured way of storing design information. Thus, in addition to the legal obligation to keep such a file, there are economic and commercial advantages. The technical documentation is usually kept by the manufacturer, but in some cases, it must be presented for inspection with a notified body.
In addition to the documentation for internal use, the product must be accompanied by certain other documents for the user. Firstly, the authorities must be able to see that the product may be traded freely within the borders of the European Economic Area EEA. This is demonstrated by the type plate bearing the CE marking, the EU declaration of conformity and possibly also in the separate instruction manual. Secondly, the new owner of the product must be given information on the possible applications, how it is operated, maintenance etc.
In a few cases no CE marking shows on the product, such as for s custom-made medical device intended for a particular patient, or for partly completed machinery to be incorporated into or assembled with other machinery. In those cases, other explanatory documents are also included.