Manufacturer’s responsibilities

It is the manufacturer’s responsibility to ensure that their machinery conforms to the applicable laws and is safe to use. Manufacturers’ responsibilities are laid down in the Finnish Government Decree on the Safety of Machinery (400/2008, “Machinery Decree”). Pursuant to the Machinery Decree, the manufacturer or their authorised representative must, prior to making machinery available or commissioning it for their own use,

  • finds out the requirement concerning the machinery
  • conducts a risk assessment for the machinery (SFS-EN ISO 12100:2010, 14121-1 and -2)
  • ensures that the machinery satisfies the applicable essential health and safety requirements (Machinery Decree, Annex I)
  • ensures that the technical file associated with the machinery has been made available (Annex VII, Part A),
  • supplies all the information required to operate the machinery (such as operating instructions)
  • demonstrates the conformity of the machinery with section 7 of the Decree (400/2008)
  • draws up an EC declaration of conformity and ensures that it will be supplied with the machinery (Annex II, Part A)
  • affixes the CE marking to the machinery (Annex III).

Type examination for machinery (for machinery under Annex IV)

There is a special procedure for assuring the regulatory compliance of the types of machinery listed in Annex IV of the Machinery Decree as well as protective and safety devices (e.g. certain types of woodworking and metalworking machinery, vehicle servicing lifts and refuse collection vehicles) that the manufacturer or their authorised representative must follow.

Compliance with the procedure must be verifiable from the EC declaration of conformity, which must therefore specify either

  • the harmonised standards applied to the manufacturing process, covering all the essential health and safety requirements applicable to the machinery
  • the number of the EC type-examination certificate and the name, address and identification number of the notified body that carried out the type examination, or
  • the name, address and identification number of the notified body that approved the manufacturer’s full quality-assurance system.

Inspectors can ask Finnish manufacturers, importers and retailers to supply EC type-examination certificates in order to check that the certificate is still valid and that it can be unequivocally linked to the labelling and documents associated with the machinery in question. It may also be necessary to check from the European Commission’s online database that the notified body stated in the certificate has been authorised to carry out type examinations on the machinery in question or approve full quality-assurance systems in the Member State in which it is established.

When manufacturing machinery, it must be noted that regulations such as the Machinery Directive (2006/42/EC) has been implemented with the corresponding Government Decree (400/2008), but matters concerning the use of the machinery are governed by the national regulations of the Member States, such as periodic inspections of vehicle servicing lifts.  

Notified bodies Nando

Technical files for machinery

Technical files for machinery allow manufacturers or their authorised representatives to prove that their machinery satisfies the applicable requirements. They must also make the file available to the authorities. The criteria that technical files for machinery must meet are laid down in Annex VII, Part A of the Machinery Decree.

Technical files do not need to be physically within the European Union or always accessible, but manufacturers must ensure that someone based within the European Union is able to compile the file and supply it to the authorities upon request. The name and address of the individual or company with this responsibility must be stated in the EC declaration of conformity. Not being able to obtain a technical file or a part thereof upon a reasonable request could lead the competent authority to suspect that the machinery in question does not satisfy the applicable essential health and safety requirements.

If, for example, an occupational safety and health inspector finds risk factors that are usually eliminated from the kind of machinery in question, he or she can ask the manufacturer, if the manufacturer is based in Finland, or the retailer of the machinery for information on how the manufacturer has assessed these risks and sought to mitigate them. On the other hand, it is the manufacturer’s duty to ensure the strength of any machinery or equipment used for lifting by means of tests or calculations, and an inspector can request to see the test results and strength calculations if he or she suspects that the machinery is not strong enough.