What is this article about?
A manufacturer within the meaning of the Machinery Directive 2006/42/EC plays a central role in ensuring that machines and safety-related components placed on the market in the European Union comply with the specified safety requirements. The Machinery Directive, which came into force in 2006, is designed to protect users from potential hazards associated with the use of machinery. It defines clear responsibilities for manufacturers and other economic operators such as importers and distributors.
This article explains who is considered a manufacturer within the meaning of the Machinery Directive 2006/42/EC , what obligations they have and the importance of this role for the safety of machinery and compliance with EU law.
Who is a manufacturer within the meaning of the Machinery Directive?
According to the definition in the Machinery Directive 2006/42/EC, a manufacturer
any natural or legal person who is responsible for the development, design or manufacture of machinery or an incomplete product and places it on the market under his own name or trademark.
This means that the person or company that places the machine or component on the market is considered the manufacturer – regardless of whether they manufactured the product themselves or had it manufactured by a third party.
Key points of the definition
- Natural or legal person: A manufacturer can be either an individual (natural person) or a company (legal person). Thus, anyone who designs, manufactures or places machinery on the market can fall within the scope of the Machinery Directive.
- Own brand or name: It is crucial that the machine is brought to market under the manufacturer’s name or brand. Even if a company has the machine produced by a third party, as the brand owner it bears full responsibility for compliance with safety requirements.
3. Placing on the market: ‘Placing on the market’ means the first distribution of the machine in the European Union. The moment a machine is made available – whether by sale, rental, leasing or any other distribution model – it is considered to be ‘placed on the market’ and the manufacturer must ensure that all relevant safety requirements are met.
Obligations of the manufacturer under the Machinery Directive 2006/42/EC?
The Machinery Directive sets out extensive obligations for manufacturers to ensure that machines are placed on the market safely and in accordance with legal requirements. The most important obligations include:
safety requirements
The manufacturer must ensure that the machine meets all the essential health and safety requirements of the Machinery Directive. These requirements cover various aspects of the machine design, including:
- Mechanical hazards (e.g. moving parts),
- Electrical hazards,
- Ergonomic aspects,
- noise emissions and
- Dangers due to unforeseen operational disruptions.
These requirements are detailed in the annexes to the Machinery Directive. The manufacturer must identify these risks and take measures to minimise them.
Technical Documentation
Manufacturers must prepare technical documentation for each machine. This documentation serves to demonstrate that the machine complies with the requirements of the Directive. It must be available throughout the machine’s lifetime and includes, among other things:
- design drawings and descriptions,
- calculations and analyses for risk assessment,
- test reports,
- operating instructions and
- Information on standards or technical specifications used to comply with the safety requirements.
declaration of conformity
The manufacturer must issue an EC declaration of conformity confirming that the machine complies with the requirements of the Machinery Directive 2006/42/EC. This declaration is a formal document that must also accompany the product and be accessible to the user. The declaration must contain, among other things, the following information:
- Name and address of the manufacturer,
- description of the machine,
- Indication of the harmonized standards or other technical specifications applied,
- Signature of the person responsible.
CE marking
A machine may only be placed on the market if it bears the CE marking. This marking shows that the machine complies with the relevant EU directives – in this case the Machinery Directive – and that the manufacturer has taken all the necessary steps to ensure conformity. The CE marking must be clearly visible and permanently affixed to the machine.
risk assessment
The manufacturer is obliged to carry out a risk assessment to identify all potential risks that may arise from the machine. Based on this assessment, the manufacturer must ensure that appropriate protective measures are taken. This can be done through design safety measures, safety devices or through information in the operating instructions.
operating instructions
Every machine must be supplied with an instruction manual written in the user’s language. This manual contains, among other things, information on how to use the machine safely, how to maintain it and how to avoid hazards. Manufacturers are obliged to ensure that the instruction manual is understandable and complete.
Special Cases and Definitions
There are certain cases in which the definition of a manufacturer within the meaning of the Machinery Directive can be extended or supplemented:
- Authorised representative: A manufacturer can appoint an authorised representative within the EU to assume certain obligations on behalf of the manufacturer, such as drawing up the technical documentation or issuing the declaration of conformity. This is particularly relevant for manufacturers outside the EU.
- Partly completed machinery: An incomplete product or incomplete machinery that does not yet meet all the requirements of the Machinery Directive may only be placed on the EU market if it is accompanied by assembly instructions and a declaration of incorporation. The manufacturer of the incomplete machinery must ensure that the final product meets all safety requirements after assembly.
Importers and distributors: Importers and distributors who import machinery into the EU and distribute it under their own name or brand are also considered manufacturers. They have the same obligations as the actual manufacturer with regard to compliance with the Machinery Directive.
Interlinking of machines: "Manufacturer within the meaning of the Machinery Directive"
The manufacturer within the meaning of the Machinery Directive is not only the actual producer in whose name and on whose account machines are placed on the internal market, see Figure 1.
A manufacturer is also considered to be someone who functionally links components (commercial goods with CE marking and manufacturer declaration from one or more manufacturers) to form machines or CE machines to form systems. He is then also legally responsible for the safety of the entire plant.
The same responsibility towards the competent authorities may also arise for a machine operator if he
builds a system of CE machines in his own company;
as soon as he builds machines for his own needs because he cannot find a “suitable” machine on the market or because he does not want to disclose internal company know-how, or
modifies a CE machine so that it better meets his needs or modifies his own old machines .
Whether the safety level (including all formalities) of a comparable CE machine must be achieved during conversion depends crucially on whether conversion measures give rise to new risks that are no longer covered by the existing protective measures. Only properly conducted hazard analyses and risk assessments can provide information on this . Anyone who makes changes as an operator must therefore carry out a hazard analysis and risk assessment .
In general, the following applies:
A manufacturer within the meaning of the Machinery Directive is the person responsible for the development and manufacture of a machine. The manufacturer has the same status as his authorized representative established in the Community. (see MaschR Art. 8 (6)).
Conclusion
The manufacturer plays a central role in the Machinery Directive 2006/42/EC. He is responsible for the development, design, manufacture and placing on the market of machines and must ensure that they comply with the comprehensive safety requirements of the directive. The obligations of a manufacturer are diverse and range from the preparation of technical documentation and the implementation of risk assessments to the provision of operating instructions and the CE marking. One can also
unexpectedly to the manufacturer within the meaning of the Machinery Directive
for example by linking machines.
Manufacturers must ensure that their machines comply with current standards and norms to ensure the safety of users while complying with legal requirements. The Machinery Directive is designed to establish uniform safety standards for machines across Europe and to facilitate the free movement of goods within the EU.
