10 Frequently Asked Questions About the Machinery Directive

By TÜV Product Service

By definition, the Machinery Directive (98/37/EC) applies to machinery, moving machines, machine installations, and machines for lifting and transporting people as well as safety components. The specified essential health and safety requirements (EHSR) of this directive cover the entire scope of mechanical engineering and are a vital aspect of the industrial community.

Overall, the Machinery Directive harmonizes the requirements of the European Union (EU) and European Norms (EN), and are the vehicles used to show compliance to these harmonized requirements. The goal of this directive is to ensure the safety of people, domestic animals, or property from threat of endangerment produced by machinery or safety components. The CE marking is affixed to a finished product, signifying that the machinery has been tested and conforms to all applicable EHSRs outlined in the directive.

Machinery manufacturers selling their products or placing their products in service within the European Union must affix the CE marking. The process of complying to this directive depends upon the machine, the scope of its use, and the applicability of the various EHSR's as they pertain to that machine. However, many of the same questions often arise concerning manufacturers' product compliance and CE marking issues.

The following are 10 commonly asked questions we frequently receive.

Q1: What is the scope of the Machinery Directive?

The Machinery Directive (98/37/EC) applies to:

• An assembly of linked parts or components;
• At least one movable part;
• Actuators, controls and power circuits;
• Processing, treatment, moving or packaging a material;
• Several machines acting in combination;
• Interchangeable equipment;
• Dangers not covered by the Low Voltage Directive;
• Not covered elsewhere by a specific Community Directive.
  

Q2: What are the (3) conformity assessment paths for CE marking to meet the Essential Health and Safety Requirements (EHSR) of the Machinery Directive?

Path I

1. Annex IV

Determine if your equipment falls under Annex IV.

2. Equipment does NOT fall under Annex IV

Create a Hazard Analysis and Technical Construction File, as required per Annex V

3. Declaration of Conformity

Create an Annex IIA Declaration of Conformity, and have it signed by the manufacturer or their EU representative.

4. CE marking

Affix the CE marking.

Path II

1. Annex IV

Determine if your equipment falls under Annex IV.

2. Equipment DOES fall under Annex IV

Were Harmonized Norms used when designing, testing, and manufacturing the equipment?

3. Harmonized Norms were NOT observed

Submit product to EU Notified body for EC type examination. Upon successful completion, the Notified Body issues an EC type examination certificate.

4. Declaration of Conformity

Create an Annex IIA Declaration of Conformity, and have it signed by the manufacturer or their EU representative.

5. CE marking

Affix the CE marking

Path III

1. Annex IV

Determine if your equipment falls under Annex IV.

2. Equipment DOES fall under Annex IV

Were Harmonized Norms used when designing, testing, and manufacturing the equipment?

3. Harmonized Norms were observed

Either:

- Submit the product to EU Notified body for EC type examination. Upon successful completion, the Notified Body issues EC type examination certificate.

- Manufacturer creates the Hazard Analysis and Technical Construction File required per Annex V and forwards it to a Notified Body, which will acknowledge receipt of the file as soon as possible and retain it.

- Manufacturer creates the Hazard Analysis and Technical Construction File required per Annex V and forwards it to a Notified Body that will simply verify that Harmonized Norms have been correctly applied, and will issue a certificate of adequacy for the file.

4. Declaration of Conformity

Create an Annex II Declaration of Conformity and have it signed by the manufacturer or their EU representative.

5. CE marking

Affix the CE marking.

Q3: Why are machines without exposed hazards covered under the Machinery Directive?

The scope of the Machinery Directive applies to all units that have:

• an assembly of linked parts or components;
• at least one movable part;
• processing, treatment, moving or packaging a material.

A machine that has moving parts that are not exposed DOES fall under the Machinery Directive (MD). A possible solution to the hazard may be a guard, however the machine is still covered by the MD. This hazard and solution must be documented in the Hazard Analysis required by the MD.

Q4: When is it mandatory to use a Notified Body for testing?

The Machinery Directive explains that a Notified Body must perform an EC type examination for Annex IV machines and safety components. This list is finite which contains:

Machinery:

• Circular Saws: sawing machines;
• Hand-fed surface planing machines for woodworking;
• Thicknessers for one-side dressing;
• Band saws;
• Combined wood working machines;
• Hand-fed tenoning machines;
• Hand-fed vertical spindle molding machines;
• Portable chain saws;
• Presses: including press breaks for cold working of metals;
• Injection or compression machines for plastics or rubber molding;
• Machinery for underground work: machinery on rails, hydraulic-powered roof supports, or internal combustion engines;
• Manually-loaded trucks for collection of household refuge incorporating compression mechanisms;
• Guards and detachable transmission shafts with universal joints;
• Vehicles servicing lifts;
• Devices for lifting of persons involving a risk of falling more than three meters;
• Machines for the manufacturer of pyrotechnics;

Safety Components:

• Electro-sensitive devices: non-material barriers, sensor mats, electromagnetic detectors, light curtains, etc.;
• Two hand controls;
• Automatic movable screens;
• Roll-over protection structures (ROPS);
• Falling-object protective structures (FOPS).

Q5: Is "grandfathering" allowed for compliance under this directive?

Most laws indicate that all products placed on the market for sale must meet the regulations by the end of a transition period. Transition periods range from months to years, depending on the directive. The only "grandfathering" permitted after the transition period is for products in use prior to the date of mandate by the final customer.

For the Machinery Directive:

• The date of implementation was January 1, 1993.
• The date of mandate was January 1, 1995.

Q6: What must be included in a Technical Construction File (TCF)?

The Technical Construction File must include:

• An overall drawing of the machinery, with drawings of the control circuits (schematics);
• Full detailed drawings, any design calculations, functional test data, etc., required to check conformity of the machinery with the EHSR;
• A list of the EHSRs;
• A Declaration of Conformity including the appropriate safety standards;
• A description of methods adopted to eliminate the hazards presented by the machinery (Hazard Analysis);
• Certificates obtained from Notified or Competent bodies (where needed);
• Technical reports that declare conformity with a Harmonized Norm;
• Operating and maintenance manuals;
• For series manufacturers, the internal measures that will be implemented to ensure that the machinery remains in conformity with this directive;

Q7: When neither the manufacturer nor his authorized local representative fulfills the obligations of the MD, who is responsible for CE marking the equipment?

These obligations shall fall to any persons placing machinery or safety components on the market in the European Union. The same obligations shall apply to any person assembling machinery or parts thereof or safety components of various origins or constructing machinery or safety components for their own use.

Q8: Has the Machinery Directive changed?

The Machinery directive, 98/37/EC and its amendment directives (91/368/EEC, 93/44/EEC, 93/68/EEC) have been consolidated and obsoleted by the new Machinery Directive, 98/37/EC. Fortunately for manufacturers of Machinery, Machinery Sub-assemblies and Safety Components there are few changes. Effective immediately (as there is no transition period), the Declaration of Conformity (Annex II A), the Manufacturers Declaration (Annex IIB) and the Declaration of Conformity for Safety Components (Annex IIC) should reference 98/37/EC, instead of 98/37/EC. The most important item, the Essential Health and Safety Requirements listed in Annex I, remain unchanged and are better defined in some cases. The most significant change is the addition of Annex VIII, which lists the repealed directives as a result of 98/37/EC. Also Annex IX correlates the original 98/37/EC with the new directive, article by article and Annex by Annex.

Q9: What language is acceptable for the instructions?

The instructions must be written in one of the EU languages by the manufacturer or his authorized representative established within the EU. Upon being placed into service, all machinery must be accompanied by a translation of the instructions into the language or languages of the country in which the machinery is to be used. The translation must be done by either the manufacturer or his authorized representative established within the EU or by the person introducing the machinery into the language area of question.

To deviate from this requirement, the maintenance instructions for use by specialized personnel employed by the manufacturer or his authorized representative in the EU may be written in only one EU language that is understood by those personnel.

Q10: Where can the Technical Construction File be kept?

The MD permits the manufacturer in North America to keep the documents. Technical Construction Files must be kept for at least ten years after the last date of manufacture of the product. The TCF can be drawn up in one of the official languages of the EU, with the exemption of the instructions. Technical documentation can be kept electronically, however it must be possible to assemble it and make it available within a "reasonable" amount of time.

These questions provide an insight into the Machinery Directive, but should not be construed as an exhaustive listing of issues, that if resolved would prove conformance with CE marking requirements. The Machinery Directive applies differently depending upon the machine's scope and use. Before seeking the CE marking for the Machinery Directive, it is recommended to consult experts and the directive itself, before proceeding further into the process. A thorough understanding of applicable directives and how they apply to your machine will enable the CE marking process to proceed more efficiently and free of costly delays.

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