CE marking is a essential part of the EU’s harmonisation legislation, which is mainly managed by Directorate- General for Internal market, Industry, Entrepreneurship and SMEs. The CE marking for Restriction of Hazardous Substances is managed by Directorate-General for Environment. Comprehensive guidance on the implementation of EU product rules can be found in the so-called Blue Guide; see chapter guidelines.
The most important provision regarding product safety, or "Product Compliance", for mechanical engineering companies is the Machinery Directive 2006/42/EC and for manufacturers of electrical equipment the Low Voltage Directive 2014/35/EU. These directives primarily designate two " parties" - the manufacturer and his authorised representative - who are responsible for placing the product on the market or commissioning.
Authorised representative in this sense is only an external representative. This does not refer to authorisations within the manufacturer.
manufacturer according to the Machinery Directive, Art. 2
"any person who designs and/or constructs a machine and is responsible for its conformity with this Directive with a view to its being placed on the market under his own name or for his own use".
Manufacturer according to Low Voltage Directive 2014/35/EU, Art. 2
"any natural or legal person who manufactures electrical equipment or has electrical equipment designed or manufactured and markets such equipment under his own name or trademark"
Anyone who designs a machine or has a machine designed as a company manager or employee is therefore not a manufacturer, because the machine is then placed on the market not in his name but in the name of the company. The "manufacturer" is therefore the company - a legal entity.
Sanctions based on these regulations are therefore directed at the company, which is usually a corporation, and not at its management. This is also not addressed anywhere in European product safety law. However, this does not mean that there are no duties for top management, nor that top management is not responsible for product safety. In addition to the administrative law enforced by the authorities, managers must take two further points into account:
- Public prosecutors (criminal law); and
- equivalent legal entities
i.e. private persons or companies who sue for damages on the basis of private law provisions.
Responsibility of the management board
The starting point of the responsibility of the company management - e.g. the executive board or the board of directors - is the so-called " universal responsibility". This means that the management is basically responsible for all matters of the company.
Liability management through resort allocation
There is the possibility of horizontal delegation through the creation of business units or departmental responsibilities. CE tasks could, for example, be assigned to the " Engineering" department and separated from Finance, Personnel and Sales. This division of responsibilities must be clear and should be agreed in writing. As regards form, courts require clarity and written form:
The diligence of a prudent Businessperson requires an unambiguous clarification in advance as to which manager is responsible for which area. Consequently, there must be a predetermined and thus at least written division which refers each individual task to the area of responsibility of at least one managing director.
at least in writing: e.g. designation of the various responsibilities in the managing director's service contract,
in addition, a managing director's resolution in the sense of a schedule of responsibilities,
even better (but inflexible) a resolution of the shareholders in the articles of association.
Health and safety compliance in Australia and New Zealand| Andreas Beyer
Lookout to achieve compliance inline with European standards to meet essential health and safety requirements in AU/NZ.
Presumption of conformity| CEmarking TEAM
The aim of the European Union is to provide you as a manufacturer with the best possible support in meeting your CE obligations. Your CE obligations consist, among other things, of fulfilling all basic health and safety requirements that apply to your products. And this for each harmonised legal
CE marking of hydraulic valves| CEmarking TEAM
Hydraulic valves used in control systems for machines and plants are neither incomplete nor individually usable machines. The Machinery Directive therefore does not stipulate CE marking for hydraulic valves. In general, the markings according to other European directives are also not applicable.
Tools - Outside the scope of the Machinery Directive| CEmarking TEAM
Interchangeable equipment Interchangeable equipment must also bear a CE marking and, according to Machinery Directive Article 2(b), must have the following characteristics: Interchangeable equipment is a device which the operator himself attaches to a machine Interchangeable equipment changes
Liability in the event of a recertification| CEmarking TEAM
Who is liable for damages in the event of a re-certification? There are two different forms of liability: the more well-known and feared criminal liability and the civil liability. Both types of liability pursue different objectives and are based on different approaches.
Subsequent conformity assessment| CEmarking TEAM
There are still machines in operation which were "placed on the market" or "put into service" as self-produced after 31.12.1994 without meeting the formal requirements of the Machinery Directive 2006/42/EC. This means that there is no EC Declaration of Conformity for these machines and they do not
Public liability| CEmarking Team
In the case of infringements of product safety law, in addition to civil liability and the imposition of a fine under public law, criminal liability also comes into consideration if and insofar as a product has injured or killed product users or uninvolved third parties.
Six Steps to CE marking| ELCO
1. Categorise the Product Identify the directive(s) applicable to your machinery, production line or plan design and allocate the applicable harmonised standards.