CE Marking of Machinery: What is a machine?

For the purposes of the Directive, one definition of a machine is:

An assembly of linked parts or components, at least one of which moves, and which are joined together for a specific application. (see Article 2 of the Machinery Directive)

Example of a machine for the purposes of the Directive.

 

The following are also considered as machines for the purposes of the Machinery Directive:

• An assembly of machines or complex plants (complex plants include production lines and special purpose machinery made up of several machines)
• Safety components (The issue of which components to classify as safety components is very controversial. As yet there is no discernible, uniform trend.)
• Interchangeable equipment that can modify the basic functions of a machine.

There is also a list of exceptions where machinery falls under the scope of the Directive by definition, but for which other statutory provisions generally apply.

Legal Principles of the CE Mark and the Machinery Directive

The obligation to affix CE marking extends to all products which fall under the scope of directives providing for such marking and which are destined for the single market. CE marking should therefore be affixed to the following products that fall under the scope of a directive:

• All new products, irrespective of whether they were manufactured in member states or third-party  countries
• Used products imported from third-party countries and second hand products
• Products that have been substantially modified and fall under the scope of the directives as new products.

The directives may exclude certain products from CE marking.

The manufacturer uses the declaration of conformity to confirm that his product meets the requirements of the relevant directive(s).

The information that follows is intended to explain CE marking in terms of the Machinery Directive.

The Basis of Machine Safety: Machinery Directive and CE mark

When the Machinery Directive (MD) was ratified in 1993, the aim was to remove trade barriers and enable a free internal market within Europe. After a two-year transition period, the Machinery Directive has been binding in Europe since 01.01.1995. It describes standardized health and safety requirements for interaction between man and machine and replaces the host of individual state regulations that existed on machinery safety. The new Machinery Directive 2006/42/EC has applied since 29.12.2009.

The CE mark stands for “Communauté Européenne”. A manufacturer uses this mark to document the fact that he has considered all the European internal market directives that are relevant to his product and applied all the appropriate conformity assessment procedures. Products that carry the CE mark may be imported and sold without considering national regulations. That’s why the CE mark is also referred to as the “Passport to Europe”.

Generally speaking, all directives in accordance with the new concept (“new approach”) provide for CE marking. Where a product falls under the scope of several directives which provide for CE marking, the marking indicates that the product is assumed to conform with the provisions of all these directives.

Standards, directives and laws in the European Union (EU)

Relationship between harmonized standards and laws in the EU.

 The European Union is increasingly merging. Machine builders will recognize this in the increasing  harmonization of laws, regulations and provisions. Not that long ago, each country published its own guidelines on the different areas of daily life and the economy, but today you’ll find more and more standardized regulations within Europe.

How are European laws, directives and standards connected?

Initially, the EU formulates general safety objectives via directives. These safety objectives need to be specified more precisely; the actual provision is made via standards.

EU directives generally deal with specific issues. The directives themselves have no direct impact on individual citizens or companies. They only come into effect through the agreements of individual countries within the EU, who incorporate these directives into their domestic law. In each EU country, a law or provision refers to the relevant EU directive and thus elevates it to the status of domestic law. Between the time a directive is adopted and the point at which it is incorporated into domestic law there is inevitably a transition period, during which time the directive awaits incorporation into domestic law in the individual  countries. However, for users this is generally unimportant because the directives themselves provide clear indication on the respective validity date. So although the titles of these documents describe them almost harmlessly as directives, in practice they have legal status within the EU.

This explains how laws and directives are connected, but doesn’t deal with the issue of the standards.

Although the standards themselves make interesting reading, on their own they have no direct legal relevance until they are published in the Official Journal of the EU or are referenced in domestic laws and provisions. These are the publications by which a standard can acquire “presumption of conformity”. Presumption of conformity means that a manufacturer can assume he has met the requirements of the corresponding directive provided he has complied with the specifications in the standard. So presumption of conformity confirms proper conduct, as it were. In a formal, legal context this is called a reversal of the burden of proof. Where the manufacturer applies a harmonized standard, if there is any doubt, misconduct will need to be proven. Where the manufacturer has not applied a harmonized standard, he will need to prove that he has acted in compliance with the directives.

If a manufacturer does not comply with a standard, it does not necessarily mean that he has acted incorrectly. Particularly in innovative industries, relevant standards either may not exist or may be inadequate. The manufacturer must then demonstrate independently that he has taken the necessary care to comply with the safety objectives of the relevant directives. Such a route is usually more complex but, in an innovative industry, it is often unavoidable.

It’s important to stress that the EU does not publish every standard in the Official Journal, so many are still not harmonized. Even if such a standard is deemed to have considerable technical relevance, it will still not have presumption of conformity. However, sometimes a standard that has not been listed in the EU Official Journal does achieve a status that’s comparable with harmonization. This is the case, for example, when a harmonized standard makes reference to the respective standard. The standard that is not listed in the EU Official Journal is then harmonized “through the back door”, as it were.

Product Liability and Protective Laws

In addition to the broad text of the general clausein § 823 para. 1 of the German Civil Code (BGB), liability  to pay compensation may also arise in accordance with § 823 para. 2:

§ 823 para. 2 of the German Civil Code (BGB) “The same liability (meaning liability to pay compensation) is held by anyone who breaks a law that is intended to protect another person.”

In this case, the activity that violates the protected right violates a “protective law”: Protective law means that the respective legal provision is (also) intended to protect the individual through some other body of legislation and therefore, in the event of damage, violation of the law itself already establishes liability for compensation.

In terms of the liability risks from violating a protective law, special laws that determine safety requirements for certain product groups have a role to play. The most important of these is the law covering technical work equipment and consumer products (Equipment and Product Safety Act/GPSG), as it covers a wide range of products: Hair dryers, kettles and skid loaders fall under its scope just as much as respiratory equipment and complex machinery. As various EC CE marking directives have also been “reflected” nationally via the GPSG and its subordinate ordinances (incl. the low voltage, ATEX, machinery, toys, pressure equipment, recreational craft, lifts, gas appliances directives), failure to comply with the safety specifications contained in the CE regulations can lead to unexpected liability risks. Further CE directives
have been implemented via separate legislation, which can also be combined with § 823 para. 2 of the German Civil Code (BGB) in the event of damage (e.g. EMC Act/EMVG, Medical Product Act/ MPG, Radio and Telecommunications Terminal Equipment Act/FTEG).

So, if an unsafe product is put into circulation, liability may arise due to violation of this type of technical safety regulation – in addition to liability under the Product Liability Act and § 823 para. 1 of the German Civil Code (BGB).

 

Hazard prevention measure, warning, retrofit, recall

If after-sales product monitoring establishes that a product which has been put into circulation fails to meet safety expectations, the producer should check whether a hazard prevention measure is indicated with regard to the respective product, in order to avoid liability risks. In the context of this Safety Compendium, this includes any measures to prevent, remove or reduce hazards emanating from products that have already been put into circulation (e.g. warnings, new operating instructions, safety uploads, on-site retrofits or factory recalls).

Prerequisites for hazard prevention measure
There is no general answer to the question as to when such a hazard prevention measure must be implemented. It depends on the circumstances of the individual case, taking into consideration the extent of the threatened damage and the likelihood of its occurrence. Expressed in economic terminology, the “expected loss value” is decisive, i.e. the product resulting from the extent of loss and the probability of occurrence. The producer must therefore analyze:

1. How high is the probability of the damage occurring:
Are individual batches affected or does the defect apply to the whole series? Does the damage occur when the product is applied in accordance with its intended use or only in cases of foreseeable misuse? Does it need an accumulation of multiple random behavior modes? Does the damage only occur after an extended period of use? Do the operating instructions contain a warning against this behavior?

2. What is the threatened damage: 
 Assuming that the product defect results in damage, what is to be expected? Simply material damage or minor, even serious personal injury?

Purely economic reasons (i.e. high recall costs or loss of image) are not an argument for rejecting the implementation of a hazard prevention measure, particularly when significant protected rights are at stake.

Provided the damage occurred in conjunction with the use of the product, it is irrelevant whether it’s already been possible to establish the actual cause of the damage in detail. So it is not acceptable to wait until an established engineering process has been followed concerning the cause of the damage. However, the producer will of course have the opportunity to check whether a product defect is actually present before introducing any measures. So there is no need for any knee-jerk reactions.

If the producer receives notification of damage, during product monitoring for example, he can first of all initiate some checks to verify whether the reported damage (e.g. a fragile glass part) can actually be attributed to a product defect or is purely down to transport damage or damage resulting from improper use. If it is established that a product defect is responsible for the damage, the producer must launch countermeasures, even if it has not yet been established whether the defect occurred during the temperature setting, for example, or in some other area of the glass blowing process.

Internal company risk prevention
It makes sense to set up an internal recall management procedure which, in case of an emergency, will enable a fast, efficient reaction to any product hazards that arise. Taking out recall insurance is another factor to consider.

Product Liability: Liability of the supplier

Liability of the Supplier

The supplier is the producer of a subproduct. He must therefore be responsible for any hazards emanating from his subproduct.

The design obligations for the supplied parts depend to a certain extent on the purchaser’s safety expectations. If the supplier knows the intended use of the end product, he must manufacture an appropriate part. He must also consider any known or conceivable misuse of the end product by the end user. In particular he must comply with the prescribed specifications and quality assurance requirements of his client.

The supplier is also obliged to warn his client of any hazards associated with the supplied product, which will not be generally known in the end producer’s own industry. The supplier must provide plain answers to his client’s inquiries about specific hazards. However, the supplier may plead ignorance to questions regarding product suitability, provided there is no further duty of disclosure.

 The Federal Court of Justice (FCJ) decided as follows: A producer purchased 25 kg hobbocks, i.e. metal buckets with two movable carry handles, from a supplier. A painter had an accident while carrying one of these hobbocks, which he had filled with a 50 kg plastic mass. The end producer had previously asked the supplier whether the bucket could carry a 50 kg load. The supplier replied that the bucket was suitable for 25 kg and if he wished to fill it with 50 kg, that was his decision. The FCJ decided that the supplier was entitled to give this reply, from which it was clear that the suitability of the product was only assured up to a 25 kg load.

Liability in the event of joint production

The legal concept of the one-stop producer who manufactures every part of his product himself before assembling it has long felt like a historical description and is barely seen now in practice, with ever lower vertical integration. This division of labor in production creates new questions, particularly with regard to how areas of responsibility are divided between supplier and end producer.

Liability of the producer of the end product

Liability of the producer of the end product
The end producer or assembler, who puts the individual product components together, has overall liability for the end product being free from defects.

In the area of design, the end producer must ensure that the product part purchased from the supplier fulfills the function for which the end product is intended to be used, in accordance with the material specifications and load capacity parameters. So one of the most important tasks of the end producer is to specify the supplied product correctly and in detail. He must describe this precisely (e.g. material type, material properties, degree of hardness, dimensions, tolerance ranges, weight, manufacturing specifications, load capacity, reject ppm values, test methodologies etc.). Through precise target specifications he must also ensure that the supplied product does not show any safety-related defects (e.g. description of all operating conditions, application areas, operating hours, information regarding peak load, potential for excess mechanical stress, potential for misuse).

In terms of manufacturing, it is the responsibility of the end producer to ensure that the correct material is selected and used in the production of the supplied products. If the end producer does not come to an agreement with the supplier about the way in which the product is to be manufactured, whether through instruction or contractual agreement, he must undertake a type test of the supplied product in accordance with the latest state of scientific and technical knowledge.
 
Example: The material, diameter and thread of screws should be tested for load capacity; bottles of mineral water for pressure resistance; carry handles and mounting brackets for tear strength.

These testing obligations can be delegated in part to the supplier; in practice this is often achieved through quality assurance agreements. These will relate to the design and manufacture of the product and will specify certain quality assurance measures and test techniques. In practice, the details are legally very demanding.

For the necessary specifications and inspections or tests, reference is often made to a technical standard. Additional quality assurance measures such as a feasibility study result in the supplier’s implementation program.

Case law has decided that the end producer can rely on the fact that the supplier builds the components to the contractually agreed quality requirements and inspects the quality himself. By selecting a renowned supply company who will carry out a thorough inspection, secure the necessary certification for the component and conclude quality assurance agreements, the end producer can reduce the level of his own inspection work.
 
An end producer must also warn against any hazards resulting from the danger associated with the supplied product. What’s more, the end producer is obliged to forward the usage instructions or warnings provided by the supplier to the user of the product, and to incorporate these into the overall operating manual that he will produce.

Product Monitoring Duty

Liability in tort recognizes another defect group, known as product monitoring defects. This duty does not concern the producer until the product he has developed and manufactured is put into circulation. This term was developed from case law and describes the producer’s obligation to monitor the product in terms of its safety-related behavior on the market, even after it has been successfully put into circulation.

The producer must track the application of his product in practice, i.e. by evaluating specialist findings in  industry journals, in the media or at specialist events and exhibitions. The product monitoring duty also includes monitoring product development at key competitors.
A well structured, internal organization is therefore required, to ensure that:
• monitoring of the market is guaranteed
• the relevant information is evaluated and
• the report reaches the decision maker.

A sophisticated product monitoring program can be achieved as part of a company’s quality assurance management.

As a second step, decision makers must draw conclusions from any notifications of damage. The following questions need to be answered:
• Does the existing design need to be changed for future product series?
• Should additional hazard warnings be incorporated for existing and future customers?
• Does a previously undetected product hazard indicate the need for an avoidance measure (e.g. a public warning, a retrofit action or a recall)?

For example, once a product has been put into circulation, should increased notifications of damage and new academic reports in the technical press reveal that a certain safety bolt ceases to be effective at high temperatures, the producer will indicate on any unsold products that additional protection is required during the summer months. At the same time he will inform his customers about the risk. If the customers are known to him by name, this will be easy to carry out, but this is unfortunately quite rare in practice. Where the names of customers are unknown, a retrospective warning via the main points of sale, technical journals or other public media will need to be considered.

However, the producer does not have to consider instances of misuse in terms of product monitoring. If the product is used for purposes other than those intended or is converted without authorization, there is no obligation to act in terms of product monitoring.

Example: An industrial operator buys a complex technical machine and converts it without  authorization or agreement from the producer; the original producer is not required to advise the operator of any safety deficiencies relating to the conversion. 

Product Liability: Principles of the duty to warn

Lawyers also understand that certain risks are technically and structurally unavoidable. The user must be able to protect himself by behaving correctly, but at the same time he must be aware of the residual risk. For this reason, case law has given producers a duty to warn: The duty in this case is to further minimize the residual risk with the aid of operating instructions, warnings, symbols, training specifications etc. The principle here is that, wherever possible, a product should be designed to be safe and free from defects. The producer cannot therefore be content to overlook these options and simply refer to the hazards. The duty to warn refers to the residual risks that remain on a product even when every possibility has been exploited in its design and  manufacture.

Definition of the producer’s duty to inform should always be based on the least informed group. The greater the  extent of the potential consequential loss and the more concealed the danger, the more explicit the warnings must be. If the product harbors a health risk, warnings must be so explicit that the user deems the danger  plausible. In such cases, general guidelines regarding correct behavior are not enough; the threatened  consequences and health risks in the event of non-compliance must be described.

Indicating that the safety gap must be set correctly before using the machine and that this setting must be checked, is not enough. Appropriate warnings must make it clear that there is the threat of a serious hand injury if the safety gap is not set correctly.

There is no duty to inform where such information is evident to the general public or to specific user groups.

For example, it is evident and recognizable that a knife can cut.

The duty to warn also extends to obvious misuse of the product. However, the producer does not have to account for unreasonable, unforeseeable and improper use of his product.

Operating instructions should not only show the correct way to install or assemble the product, but must also provide separate warnings against incorrect hand movements that may be obvious and occur frequently.


By contrast, case law highlights that the producer can rely on a technically trained operator keeping to the dedicated specifications provided in the operating instructions. Thus, should a kneading machine operator attempt to open the lid seal by heating the modelling clay until excess pressure inside the machine removes the lid, this would be deemed “gross misuse”.

The warning against potential hazards arising from the product should be issued without embellishment at the point at which the user will expect to find it. It would not be right, therefore, to position information about potential product hazards in some hidden location within the operating manual. 

The producer must also take care to ensure that the user of the product understands the operating  instructions. So a significant factor initially is whether the user can actually read and which languages he understands. This immediately implies the question about the languages into which a manual’s safety guidelines should be translated. It goes without saying that the safety guidelines in an operating manual should always be translated into the language of the country in which the product will be sold. The producer cannot assume that the company responsible for international sales of a product in a particular country will also provide an  adequate translation, including that of the relevant warnings, into the respective local language.

Product Liability: Violation of Duty of Care, Design and Manufacturing Defect

Violation of Duty of Care

In line with § 823 of the German Civil Code, case law has categorized the incorrect behavior of a producer (violation of duty of care) into error groups: To differentiate technically between potential defect causation, a distinction is made between four defect groups:

• Design defect
• Manufacturing defect
• Warning defect
• Product monitoring defect

Design Defect
Lawyers talk about a design defect when the whole product line shows the same defect in the technical design. Through organizational means the producer must guarantee compliance with all safety design specifications (e.g. from EC directives) and technical regulations. This will often require material and product tests in accordance with the latest state of scientific and technical knowledge.

 The producer is obliged to design his product in such a way that the average user can use it without risk, in accordance with its stated intended use; any hazards resulting from a foreseeable misuse should also be considered.

For example, in the case of lifts or other means of conveyance, it is important to consider that they will be exposed to a certain amount of overload. For this reason, if the holding ropes on a lift should tear when only slightly overloaded, this would be considered a design defect.

Manufacturing Defect 
Manufacturing defects are characterized by the defective production of individual parts and have nothing to do with the design process; instead they relate to the manufacturing process.

Examples of manufacturing defects: a poorly forged steam trap, a faulty welding seam on the motor, individually occurring material defects on a light grid, incorrect granulate mixture on bimetallic coatings, excessive sputtering on circuit boards.

Outliers present a special case. Outliers are production and manufacturing defects that are unavoidable or undetectable despite all reasonable precautions. Case law introduced a liability exemption for this defect group back in the 50s and 60s; producers are not liable for such outliers in the absence of fault. Nonetheless it is important to stress that liability for outliers still exists under the Product Liability Act because fault plays no role.