How machinery is CE marked?
Before the manufacturer is allowed to place its machinery on the EU market or put it into its own use in the EU, certain requirements must be met. Placing on the market means making machinery available on the EU market for the first time with a view to, for example, sell or rent. The manufacturer demonstrates the compliance with the CE marking. Machinery that bears the CE marking can move freely in the EU.
The manufacturer of the machinery must:
- assess the risks of the machinery and determine the applicable essential health and safety requirements
- design and construct the machine in accordance with the safety requirements
- prepare a technical file
- carry out an appropriate conformity assessment procedure for the machinery, the procedure to be applied in the assessment depends on the machinery
- prepare the operating instructions, which in Finland must be in Finnish and Swedish, and affix the required markings
- draw up the declaration of conformity
- when the above measures are completed, affix the CE marking to the machinery.
Essential health and safety requirements for the machinery
Machinery must be designed and constructed in accordance with the essential health and safety requirements specified in Annex I of the Machinery Decree.
In order to determine the health and safety requirements to be applied to the machinery, the manufacturer of the machinery must carry out a risk assessment of the machinery. After this, the machinery must be designed and constructed taking the risk assessment results into account.
When the risks are assessed and the necessary protective actions are determined, forseeable misuse of the machinery must also be taken into account.
Harmonised standards
The manufacturer can use harmonised standards to assist in meeting the requirements. Harmonised standards are drawn up so that the machinery is deemed to comply with the essential safety requirements if the harmonised standards are complied with in full when designing and constructing the machinery.
If the manufacturer does not comply with the requirements of the harmonised standards in full, the manufacturer must be able to prove that a similar level of safety is achieved with an alternative solution.
The harmonised standards relating to the safety of machinery fall into three basic categories:
- A-type standards: fundamental safety standards that can be applied to all machinery.
- B-type standards: deal with specific aspect of safety or protective device.
- C-type standards: machine-specific standards.
The harmonised standards under the Machinery Directive can be found on the European Commission's website.
General information on harmonised standards can be found on page Standards.
Conformity assessment procedure
The conformity assessment procedure means measures that the manufacturer must take to assess whether the machinery complies with the essential health and safety requirements and the rules on the CE marking.
The majority of the machinery intended for consumer use is placed on the market by applying the procedure for assessment of conformity with internal checks on the manufacture. In the case of internal checks, the manufacturer itself ensures that the machinery complies with the relevant requirements. This procedure does not require the participation of a notified assessment body or other external party.
With regard to machinery that is deemed to involve higher risks, the manufacturer can select from three different procedures depending on whether the machinery is constructed in accordance with harmonised standards or not. These categories of machinery are listed in Annex IV of the Machinery Decree. Of the machinery intended for consumer use, these categories include, for example, chainsaws.
Below is a simplified flowchart of procedures to bring the machinery into conformity. More information on the conformity assessment procedures (EC type examination, full quality assurance) can be found in Annexes VIII to X of the Machinery Decree.
Technical file
The manufacturer must compile a technical file for the machinery. The technical file enables the manufacturer to demonstrate the conformity of the machinery as necessary. On the other hand, failure to present the technical file may constitute sufficient grounds for doubting the conformity of the machinery.
The technical file does not have to be permanently in written form, and it does not have to be located in the EU. This means that the term ‘technical file’ refers to a body of information that can be stored on paper on in electronic form in one or several places.
In the EC Declaration of Conformity, the manufacturer must designate a person who is capable of assembling the file and making it available within a reasonable time in response to a request by a competent surveillance authority. The technical file must be compiled in one or more official languages of an EU Member State. The file must be kept and made available to any competent authority for at least 10 years following the date of manufacture of the machinery or, in the case of series manufacture, of the last unit produced.
The technical file must contain the following information, among others:
- a general description of the machinery
- the overall drawing of the machinery with the necessary descriptions and explanations
- full detailed drawings, calculation notes, test results, etc.
- the documentation on risk assessment, demonstrating
- the procedure followed
- the essential health and safety requirements that apply to the machinery
- the description of the protective measures implemented to eliminate identified hazards or to reduce risks
- where appropriate, the indication of the residual risks
- the standards and other technical specifications, including the information on the extent they are applied to
- where appropriate, any technical report giving the results of the tests carried out either by the manufacturer or by a body chosen by the manufacturer
- a copy of the instructions for the machinery
- a copy of the EC Declaration of Conformity
- for series manufacture, a report on the consistency in the quality of the machinery.
Instructions
All machinery must be accompanied by instructions in a language that is clear and understandable to the consumer. In Finland, the instructions must be in Finnish and Swedish, and if the machinery is exported elsewhere in the EU, in the language of the country in question. When drafting the instructions, account must be taken whether the machinery is intended for professional use or consumers, and any reasonably foreseeable misuse must also be taken into account.
The instructions of the machinery must contain at least the following information:
- the business name and address of the manufacturer or its authorised representative
- the designation of the machinery
- the EC Declaration of Conformity or corresponding information, except for the serial number and the signature
- a general description of the machinery
- putting the machinery into service
- safe use of the machinery
- where appropriate, handling and transportation instructions
- maintenance and upkeep instructions
- where appropriate, information on the tools that may be fitted to the machinery
- where appropriate, ways in which the machinery must not be used
- where appropriate, information on the residual risks and the necessary personal protective equipment.
In addition, the instructions must include the information on noise emission and, where appropriate, on vibration emission. The contents of the instructions is specified in detail in Annex I of the Machinery Decree.
Markings
All machinery must be marked visibly and indelibly with the following minimum particulars:
- the business name and full address of the manufacturer and, where appropriate, its authorised representative
- the designation of the machinery
- CE marking
- designation of series or type
- serial number, if any
- the year of construction.
The machinery must also bear information essential for safe use. The harmonised standards that are specific to a type of machinery specify the information that must be marked on each type of machinery.
EC Declaration of Conformity
In the EC Declaration of Conformity the manufacturer or its authorised representative confirms by signature that the machinery complies with the essential health and safety requirements that apply to the machinery. The declaration of conformity lists the provisions and any possible standards and corresponding specifications that are applied to the machinery.
Once the declaration of conformity is prepared and signed, the CE marking can be affixed to the machinery and the machinery can be placed on the market. The declaration of conformity must accompany the machinery, for example, as an attachment to the operating instructions. In Finland, the declaration of conformity must be in Finnish and Swedish, in addition to the original version of the declaration.
The EC Declaration of Conformity must contain the following information:
- business name and full address of the manufacturer and, where appropriate, its authorised representative
- name and address of the person authorised to compile the technical file. This person must be established in the Community.
- description and identification of the machinery
- a sentence expressly declaring that the machinery fulfils all the relevant provisions of the Machinery Directive and, where appropriate, a similar sentence declaring the conformity with other directives or provisions
- where appropriate, the name, address and identification number of the notified body which carried out the EC type examination, and the number of the EC type-examination certificate
- where appropriate, the name, address and identification number of the notified body which carried out the full quality assurance procedure
- where appropriate, a reference to the harmonised standards used
- where appropriate, a reference to other technical standards and specifications used
- the place and date of the declaration
- the identity and signature of the person empowered to draw up the declaration on behalf of the manufacturer or its authorised representative.
General information on the EC Declaration of Conformity can be found on page EU Declaration of Conformity, see also an example of an EC Declaration of Conformity of the machinery (example of an EC Declaration of Conformity of the machinery in PDF format (in Finnish)).
CE marking
The CE marking demonstrates that the machinery complies with all relevant requirements of the directives and EU regulations that apply to the machinery and are necessary for the CE marking. The CE marking is affixed to the machinery by the manufacturer or a representative authorised by the manufacturer in writing.
The EC Declaration of Conformity must show the EU legislation under which the CE marking is affixed. In the case of machinery specified in Annex IV of the Machinery Decree for which the quality assurance procedure approved by a notified body has been applied for demonstrating compliance, the CE marking must be followed by the four-digit identification number of the body in question.
The CE marking must be affixed visibly, legibly and indelibly in the immediate vicinity of the name of the manufacturer or its authorised representative, using the same technique.
General information on the CE marking can be found on page CE marking.
