10 Frequently Asked Questions About the Machinery Directive

By Mark A. D'Agostino

TÜV Product Service Inc. (Danvers, MA)

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 (EHSRs) cover the entire scope of mechanical engineering and are a vital aspect of the industrial community.

Overall, the Machinery Directive (MD) harmonizes the requirements of the European Union (EU) and European Norms (EN), and is the vehicle used to show compliance with 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 mark 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 EU must affix the CE mark. The process of complying depends upon the machine, the scope of its use, and the applicability of the various EHSRs.

The following are 10 questions we frequently receive.

1. What is the scope of the MD?

The MD (98/37/EC) applies to

An assembly of linked parts or components.
At least one movable part.
Actuators, controls, and power circuits.
Processing, treating, 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.

2. What are the three conformity assessment paths for CE marking to meet the essential health and safety requirements (EHSRs) of the MD?

Path I

1. Annex IV—Determine if equipment falls under it.

2. Equipment does not fall under Annex IV—Create a Hazard Analysis and Technical Construction file (TCF), 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. Affix the CE mark.

Path II

1. Annex IV—Determine if equipment falls under it.

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. Affix the CE mark.

Path III

1. Annex IV—Determine if equipment falls under it.

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 TCF required per Annex V and forwards it to a notified body that will acknowledge receipt of the file and retain it.
Manufacturer creates the Hazard Analysis and TCF 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. Affix the CE mark.

3. Why are machines without exposed hazards covered under the MD?

The scope of the MD applies to all units that have

An assembly of linked parts or components.
At least one movable part.
A function such as processing, treating, moving, or packaging a material.

A machine that has moving parts that are not exposed does fall under the 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 file.

4. When is it mandatory to use a notified body for testing?

The MD explains that a notified body must perform an EC-type examination for Annex IV machines and safety components. This finite list 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 (e.g., machinery on rails, hydraulic-powered roof supports, or internal combustion engines).
Manually loaded trucks for collection of household refuse incorporating compression mechanisms.
Guards and detachable transmission shafts with universal joints.
Vehicle-servicing lifts.
Devices for lifting persons who are at risk of falling more than three meters.
Machines for the manufacture of pyrotechnics.

Safety Components:

Electrosensitive devices (e.g., nonmaterial barriers, sensor mats, electromagnetic detectors, light curtains, etc.).
Two-handed controls.
Automatic movable screens.
Roll-over protection structures (ROPS).
Falling-object protective structures (FOPS).

5. 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 by the final customer prior to the date of mandate.

For the MD:

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

6. What must be included in a Technical Construction File (TCF)?

The TCF 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.

7. 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 EU market. 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.

8. Has the MD changed?

The MD (89/392/EEC) and its amendment directives (91/ 368/EEC, 93/44/EEC, and 93/68/EEC) have been consolidated and made obsolete by the new MD (98/37/EC). Fortunately for manufacturers of machinery, machinery subassemblies, and safety components, there are few changes. Effective immediately, as there is no transition period, the Declaration of Conformity (Annex IIA), the Manufacturers Declaration (Annex IIB), and the Declaration of Conformity for Safety Components (Annex IIC) should be referenced as 98/37/EC, instead of as 89/392/EEC. The most important item—the EHSRs listed in Annex I—remains unchanged and is even better defined in some cases. The most significant change is the addition of Annex VIII, which lists the directives repealed as a result of 98/37/EC. Another change of importance, Annex IX correlates the original 89/392/EEC with the new directive.

9. What language is acceptable for the instructions?

The instructions must be written in one of the EU languages. All machinery placed into service 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 the manufacturer, by the authorized representative in the EU, or by the person introducing the machinery into the area.

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

10. Where can the TCF be kept?

The MD permits the manufacturer in North America to keep the documents. TCFs must be kept for at least 10 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 period of time.

These questions provide an insight into the MD, but should not be construed as an exhaustive listing of issues that, if resolved, would prove conformance with CE marking requirements. The MD applies differently depending upon the machine's scope and use. Before seeking the CE mark for the MD, it is recommended that manufacturers consult experts and the directive itself. 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.