CE marking of machinery - When the operator becomes the manufacturer
Feb. 12 2020
Whoever buys a machine and puts it into operation does not have to pay attention to the CE marking at first - the manufacturer is responsible for the CE marking. However, anyone who modifies the essential characteristics of this machine or even constructs a suitable machine himself, legally speaking, becomes a manufacturer rather than an operator. The following article provides information on how the Machinery Directive, conformity assessment procedures and a renewed CE marking are correctly applied in these cases.
CE MARKING: WHAT IT APPLIES TO AND WHY IT IS SO IMPORTANT
CE is the abbreviation for Communauté Européenne (French European Union). The CE marking is based on the EU regulation VO 765/2008 and is valid for the European internal market. The basis of the marking is a central sentence in the regulation, according to which a manufacturer declares "that the product complies with the applicable requirements laid down in the Community harmonisation legislation concerning its affixing". Anyone who significantly modifies a machine makes himself the manufacturer and must therefore comply with this obligation to declare the conformity of the machine. The principles of CE marking of machines are also found in the Machinery Directive.
The CE marking, which is the visible result of a successfully completed conformity assessment procedure, is important for two reasons. Firstly, it serves the EU's harmonization thinking and the comprehensibility of markings beyond national borders. On the other hand, it serves to ensure safety when using the machines and can significantly reduce the number of accidents at work.
A short conclusion in between: For operators of machines it is therefore essential to re-apply the CE mark in the event of significant changes. This legal obligation is closely linked to the implementation of a correct conformity assessment procedure. In order to avoid sanctions in the event of omitted or incorrect CE marking, it is recommended to consult an expert as a solid basis. With our service of advice on all aspects of CE marking, we are a powerful contact in this context.
WHEN IS RE MARKING OF CE OBLIGATORY?
The obligation for CE marking according to the Machinery Directive and the legally binding implementation in German law with the 9th Product Safety Regulation (Machinery Regulation) exists in several cases. On the one hand, in the case of significant changes to machines which clearly influence their use and function and which must be made known to the user for safety reasons. On the other hand, in the case of needs-based conversions of machines which make an operator the manufacturer of a special design for individual requirements. The same also applies when machines are interlinked. All these changes bring with them the obligation to renew the CE marking for the same reason: The new characteristics of the machine make the operator a (new) manufacturer. This results in the same legal obligations that the manufacturer of the machine had in its original form. If these are not complied with, sanctions must be expected.
TAKE A CLOSER LOOK AT THE CONSTRUCTION OF MACHINERY FOR OWN USE
CARRY OUT A CORRECT CONFORMITY ASSESSMENT PROCEDURE
The conformity assessment procedure is the basis for the professional CE marking according to the Machinery Directive. The following steps are important for this.
When machinery is used for its intended purpose, the manufacturer must specify the use for which it was designed. This is also recorded in the technical documentation and provides valuable information for use in the European internal market.
The directives relating to the legislation on CE marking are very complex. The conformity assessment procedure must therefore also indicate which regulations apply in each case. The Machinery Directive is a classic example in this context.
The specified directives result in the applicable harmonised standards, which should preferably be applied to a product or machine. If these harmonized standards are met, this is referred to as presumed conformity (the "presumption of conformity"). The user of the standard can thus assume that he is in compliance with the law or the directive.
The next step marks the actual conformity assessment procedure. Here the manufacturer checks very carefully whether the machine actually complies with all relevant directives, standards and national technical regulations in full. An important part of this procedure is the risk assessment. This is where hazards that could possibly arise during use are recorded. In the risk assessment, the degree of risk reduction, which is both effective and economical, is determined by means of suitable protective measures. The technical documentation is then carried out. It includes the operating instructions, assembly instructions and circuit diagrams, in short: everything that is important and must be observed for commissioning and using the functions of a machine. Together with the declaration of conformity, it must always be available for presentation when requested by the responsible authorities.
The CE marking is the reward for the efforts made to complete the lengthy procedure. It is affixed to the nameplate and is the result of a series of tests, the accuracy and results of which are the responsibility of the respective manufacturer.
COSTLY PROCEDURE FOR THE MANUFACTURERS
Whether food or logistics, packaging or process engineering, automotive or plant construction: Wherever large machines are used, operators are obliged to initiate a new CE marking in the event of a significant change to the machine and to carry out the complex conformity assessment procedure. This complex conformity assessment process, which is a prerequisite for the correct CE marking, is not always easy and can only be carried out by the machine operator at great expense. An external expert is the professional contact person here, who saves a lot of work and often also nerves, and can also convince with the so important legal certainty.
BENEFIT FROM EXPERT ADVICE
Our service of qualified advice on CE marking for operators & manufacturers of machines is helpful for companies of all sizes and industries. As has already been explained in detail, support is also important for buyers and operators of machinery if they change the machinery to such an extent that they themselves become manufacturers from a legal point of view and have to tackle a new CE marking on the basis of the Machinery Directive. This applies equally to operators of machines as well as operators of production lines and machine parks from different industries.Möchten Sie weitere Informationen über das wichtige Thema der CE-Kennzeichnung und das Konformitätsbewertungsverfahren auf Basis der Maschinenrichtlinie erfahren?