Tried, tested and proven: Our modular process for flexible collaboration
The path to CE labelling first leads you to the product analysis and determination of the limits of use. The appropriate legal bases, in particular standards, must then be researched according to the nature of the product. CE labelling of certain product classes then requires in particular a risk assessment, which may be carried out in accordance with various extended directives such as ATEX. easyCE relies on collaboration and communication in the conformity assessment procedure. You have the option of organising our collaboration flexibly and providing the elements of the conformity assessment procedure that you require yourself. Our modular approach to collaboration has been tried and tested in dozens of projects and has proven itself over decades.
Analyse product and define limits of use?
The specific application/use of the product is of particular importance. The use or application and the limits of use are determined by the manufacturer. This is his duty. It also determines the limits of claims in terms of product liability. The clear definition of the limits of use is particularly important if the expected application by the user/operator cannot always be clearly recognised by the manufacturer or is even unknown to him or if the product is installed in another product or system. The required level of user safety must be maintained so that the manufacturer of the product is not placed at a disadvantage due to "foreseeable misuse" by the user in the life phases (e.g. transport, assembly, installation, operation, cleaning and maintenance, disposal). The "manufacturer, its authorised representative or the "distributor" is responsible for all these measures, and the use/application of a product always has consequences in terms of product safety and the associated product liability. (See ProdSG §3, §7 and ProdHaftG §3, as well as BGB §434 liability for material defects)
Identify applicable directives, laws and standards?
These requirements are specified in EC directives (RL), implemented in national laws, e.g. in the national Product Safety Act (ProdSG), and laid down in harmonised European standards (EN) as an implementation aid and, when the standards are applied, as a presumption of conformity. The manufacturer confirms the conformity of the product with the requirements of the directives/laws and the EN - also for products for own use - by means of the declaration of conformity and by affixing the CE mark. This is mandatory. If other directives apply to the product, these must also be applied in the conformity assessment procedure. (e.g. ATEX Directive 2014/34/EU, Pressure Equipment Directive 2014/68/EU and EMC Directive 2014/30/EU) etc. In addition, the relevant harmonised standards applied during design and construction must be stated in the documents (operating instructions and CE declaration). Harmonised standards are published in the Official Journal of the EU. However, this simple and straightforward description of the legal requirements harbours considerable demands on the quality and properties of machinery.
Identify, assess and mitigate risks during use
Products/machines must have certain design characteristics in order to reduce hazards to people, animals and objects to an acceptable level in all life cycles. To this end, manufacturers must carry out a risk assessment (RA) for their products to "determine the residual hazards and to select and apply suitable and appropriate means to reduce the risks". If products are used in potentially explosive atmospheres, an ignition source analysis must be carried out to identify potential ignition sources.
Operating instructions and operator responsibility resulting from the BetrSichV
The operator/user of an equipment, in turn, is obliged by the requirements of the Industrial Safety Ordinance (BetrSichV) and the ArbSchG, as well as the ArbSG to let his personnel work only on such equipment. to provide its employees with only those resources that meet the requirements of the EC directives and laws.The operator/user/employer is responsible for providing safe work equipment for the entire life cycle (see section 4 BetrSichV and section 5 ArbSchG). For this purpose, the employer carries out a risk assessment at the workplace and prepares an operating instruction for the work on or. with these resources.
Why use support for the conformity assessment procedure?
Speed up the entire process with expert advice and additional external capacity. You also reduce your uncertainty and thus your risk of exposure to product liability. By allowing your employees to focus on their core competences, they concentrate on the essentials and the flow of work is not interrupted.
