Manufacturers of machinery are subject to certain obligations arising from product safety law.

• Machine safety and acceptance testing
• Standards and directive research
• Performing measurements and tests (noise measurement, electrical safety, etc.)
• Compliance with the applicable fundamental safety and health requirements
• Preparation of technical documentation
• Keeping technical documentation available
• Conducting a conformity assessment procedure for the machine
• Conducting a risk assessment
• Drafting operating instructions
• Providing the operating instructions in the official language(s) of the user's country (or at least in English)
• Determining which directives and regulations apply and implementing them
• Issuing a declaration of conformity
• Affixing the CE marking

Manufacturers face a considerable number of obligations. Contact us and we'll support you in ensuring their safe implementation.

Operators of machinery and equipment also have numerous obligations to fulfill in order to ensure safe operation. These obligations include, among other things, conducting a risk assessment.

All employers – regardless of the number of employees – must carry out such a risk assessment and implement the results in accordance with the Occupational Health and Safety Act (ArbSchG).

We identify, assess and document the specific hazards in your company so that you can take meaningful and appropriate measures.

• Identify hazards in accordance with the German Ordinance on Industrial Safety and Health (BetrSichV)
• Identify and assess risks
• Specify necessary measures
• Document the hazard assessment
• Monitor the implementation of measures
• Ensure machine safety and carry out machine acceptance testing
• Regularly review the effectiveness of protective measures

Are you planning a modification to one of your existing systems? If so, it must be assessed whether any changes to the systems will affect safety. In this case, you may need to carry out a new conformity assessment procedure with CE marking.

We will gladly check for you whether your planned conversion constitutes a so-called substantial modification of the machine and also support you in any necessary reassessment of the existing machine.

According to the definitions in the Machinery Directive (MD), a manufacturer is anyone who produces an (in)complete machine:

• constructs and/or
• has built according to own plans,
• assembles into a whole,
• manufactures for own use or
• modifies, thereby substantially altering it.

With the revision of the German Ordinance on Industrial Safety and Health (BetrSichV), the recommendation on industrial safety "Adaptation to the state of the art in the use of work equipment" (EmpfBS 1114) was published. "State of the art" is defined therein as follows:

"The state of the art is the level of development of advanced processes, facilities, or operating methods that appears to ensure the practical suitability of a measure or procedure for protecting the health and safety of employees. When determining the state of the art, in particular comparable processes, facilities, or operating methods that have been successfully tested in practice must be taken into account."

(EmpfBS 1114)

Put simply, a significant modification occurs when the changes are so extensive that the existing safety system is insufficient to mitigate the newly created hazards and risks. "Substantial modification" is a well-established term in machine safety and is further explained in the BMAS (Federal Ministry of Labour and Social Affairs) interpretation document. According to this document, after a significant modification, a machine is considered a new product within the meaning of the Product Safety Act.

If a change is made to a machine – whether new or used – this change must be examined with regard to its impact on safety.

If a substantial modification has been made, the machine is legally considered new. It must be fully adapted to the current state of the art. The substantially modified machine must comply with the requirements of the currently applicable Machinery Directive not only in the modified areas, but in all respects.

The person who makes the significant modifications becomes the manufacturer of the machine. This results in a complete separation from the original manufacturer. In particular, this entails the following obligations, regardless of the machine's year of manufacture:

• Assumption of the manufacturer's obligations for the machine,
• Retrofitting the machine to the safety level of the current Machinery Directive,
• Carrying out a risk assessment and the conformity assessment procedure,
• Issuance of an EC Declaration of Conformity,
• Affixing the CE marking,
• Supplementing and revising the operating instructions, and
• Preparation of technical documentation in accordance with the Machinery Directive.

The manufacturer is the person who plans the modification and defines the safety requirements. The person who implements the modifications according to these specifications is not considered the manufacturer.

Unless a significant modification is detected, the modified machine must still comply with the requirements of the Industrial Safety Ordinance. The inspection for significant modifications must be documented.

For example, the following need to be adjusted:

• the risk assessment,
• the operating instructions,
• instructions and
• technical documentation such as circuit diagrams or drawings.

The measures derived from the review and risk assessment must be implemented and their effectiveness verified.

Annex I, section 1.7.4.1 of the Machinery Directive lists the required contents of the operating instructions. These include, among other things:

• the description of the intended use,
• the description, explanation, drawings and circuit diagrams for
• the use including commissioning and decommissioning,
• the maintenance,
• the repair and
• the verification of proper functions,
• the workplace descriptions,
• the instructions for protective measures such as PPE and
• measures in case of malfunctions.

The manufacturer's documentation consists of the following components:

• a general description of the machine,
• an overview drawing, circuit diagrams and explanations of its operation,
• detailed drawings for verifying the safety and health requirements,
• the risk assessment documentation including
• a list of the relevant safety and health requirements and
• a description of the risk assessment,
• a list of the standards applied,
• all relevant technical test reports,
• an operating manual and
• the EC declaration of conformity for complete machinery or the declaration of incorporation and assembly instructions for incomplete machinery.

The legal framework for partly completed and complete machinery is described in the Machinery Directive 2006/42/EC. Partly completed machinery is subject to special regulations, as it is not considered a "machine" within the meaning of the Directive.

Characteristics that support the definition of an incomplete machine are derived from the definition of an incomplete machine. Accordingly, a complete machine is characterized by the following:

• has an intended use,
• can perform a specific function on its own,
• does not need to be installed in or joined to another machine in order to perform a specific function,
• must bear a CE marking and have an EC declaration of conformity.

The incomplete machine does not bear a CE marking, and an EC declaration of incorporation and assembly instructions are available.

Following the conformity assessment procedure, the manufacturer confirms with the EC Declaration of Conformity that the machine or safety component in question complies with the essential safety requirements of the Machinery Directive and, where applicable, other applicable European directives and regulations.

The manufacturer also states that the technical documentation has been prepared in accordance with Annex VII Part A of the Machinery Directive.

The EC declaration of conformity usually also states whether and to what extent there are conformities with standards or other technical specifications.

An EC declaration of conformity must also be issued if a machine is manufactured solely for in-house use.

Annex II, section 1.A of the Machinery Directive requires the following information for the declaration of conformity:

• Company name and full address of the manufacturer and, where applicable, the authorized representative
• Name and address of the person authorized to compile the technical documentation
• Identification of the machine by a description of its general name, function, model, type, serial number, and trade name
• A statement explicitly declaring that the machine complies with all the provisions of Machinery Directive 2006/42/EC
• Where applicable, a statement of which other directives and/or relevant provisions the machine also complies with
• For machines with EC type-examination procedures: name, address, and identification number of the notified body and the number of the type-examination certificate
• If a comprehensive quality assurance system has been approved, the name, address, and identification number of the notified body
• Harmonised standards applied where applicable
• Other technical standards and specifications applied where applicable
• Place and date of the declaration
• Details of the person authorized to issue the declaration and their signature

Do you need support in preparing a declaration of conformity and in the preceding conformity assessment procedure? Contact us!

If a machine is placed on the market in Germany, the declaration of conformity, like the operating instructions, must be available in a German-language version: either as a German original or as a translation into German.

The operator of a machine receives documentation from the manufacturer.

• an EC declaration of conformity for the machine,
• an operating manual and
• if applicable, circuit diagrams for the electrical, hydraulic and/or pneumatic systems.

The indication of applied harmonized or other applied standards and technical specifications is voluntary.

If the manufacturer applies a harmonized standard and indicates this in the declaration of conformity, the presumption of conformity applies. This presumption applies only to the safety and health requirements covered by the harmonized standard. Other standards and specifications do not trigger this presumption.

The person placing a machine on the market is obligated to issue the EC Declaration of Conformity. In most cases, this is the machine's manufacturer. If the machine's manufacturer is not based in the European Union, they can authorize a company or individual based in the EU to issue the EC Declaration of Conformity. It is important to note that this person or company then also assumes liability for any safety defects.

A declaration of incorporation is a declaration for an incomplete machine, while an EC declaration of conformity certifies that the (complete) machine complies with the safety requirements of the applicable European directives and regulations.

The declaration of incorporation must state that the incomplete machine may only be put into service once it has become part of a machine and the completed machine fully complies with the requirements of the Machinery Directive.

A conformity assessment procedure is a process for evaluating the conformity of a product or service with the relevant requirements set out in applicable legal provisions, technical standards, or norms. The goal is the free movement of goods within the EEA under a uniformly high level of safety. For machinery, a conformity assessment procedure must be carried out under the manufacturer's own responsibility in accordance with the Machinery Directive. This applies to:

• new machines (machines placed on the market for the first time),
• imports from outside the EEA (including used machines),
• substantially modified machines.

A conformity assessment procedure includes the following steps:

1. As a first step, the manufacturer, using a risk assessment, ensures that the safety objectives formulated in Annex I of the Machinery Directive are met.
2. The manufacturer must compile the technical documentation according to Annex VII, Part A of the Machinery Directive and retain it for the specified periods.
3. To ensure that the machines produced in series conform to the type approval, internal production control according to Annex VIII of the Machinery Directive must be in place.
4. At the end of the procedure, the manufacturer issues the EC Declaration of Conformity and affixes the CE marking.

As a rule, the manufacturer carries out the EC conformity assessment procedure without involving independent bodies (such as TÜV). The obligation to involve a testing and certification body exists only in exceptional cases. These are described in Annex IV of the Machinery Directive.

The following CE directives are currently issued by the EU:

• Active implantable medical devices - 90/385/EEC
• Lifts - 2014/33/EU
• Construction products - 305/2011/EU
• Pressure equipment - 2014/68/EU
• Simple pressure vessels - 2014/29/EU
• Electrical equipment designed for use within certain voltage limits (Low Voltage Directive) - 2014/35/EU
• Electromagnetic compatibility - 2014/30/EU
• Explosives for civil purposes - 2014/28/EU
• Radio equipment - 2014/53/EU
• Equipment and protective systems for use in potentially explosive atmospheres (ATEX) - 2014/34/EU
• In vitro diagnostic medical devices - 98/79/EC
• Machinery - 2006/42/EC
• Medical devices - 2017/745
• Measuring instruments - 2014/32/EU
• Non-automatic weighing instruments - 2014/31/EU
• Personal protective equipment - 2016/425/EU
• Pyrotechnic articles - 2007/23/EC
• Ecodesign - 2009/125/EC
• RoHS - 2011/65/EU
• Safety of toys - 2009/48/EC
• Recreational craft - 2013/53/EU
• Cableways for passenger transport - 2000/9/EC

An assembly of machines consists of two or more complete or incomplete machines. According to the Machinery Directive, an "assembly of machines" falls under the definition of a "machine." It is also referred to as a machine system or linked system. The individual units of the assembly of machines are interconnected in terms of production technology and safety technology.

A production-related connection exists when the machines

• are arranged as a spatially coherent unit,
• are directed towards a common goal (e.g. the production of a product) and
• are operated as a whole, i.e. have a common or superior functional control or common command devices.

A safety-related connection exists when an event occurs at one unit that leads to a hazard at another unit, and joint protective measures are necessary to avert the hazard.

Whether an assembly of machines exists within the meaning of the Machinery Directive can be determined with the help of the interpretation paper on the topic "assembly of machines" – Announcement of the BMAS dated 05.05.2011.