Machinery Directive 98 37 EC

Machinery Directive 98/37/EC
CE-MARKING
What Manufacturers Need to Know & Do
Copyright 2003 QNET LLC All Rights Reserved By Yvonne Halpaus
Conformity with the Machinery Directive became STEP V: Upon completion of the Technical File,
mandatory on January 1, 1995 and covers new manufacturers who machinery is subject to self-certification may:
1) Issue a Declaration of Conformity and
and used machinery being placed on the market 2) Affix the CE-mark to the machine
for the first time. 3) Hold the Technical File contents available for the European
Competent Authorities on request.
Definitions of machinery and safety
Building of a non-complex machine Technical File requires
components within the scope an estimated 80-140 hours by an experienced design
engineer who is familiar with the Machinery Directive
Machinery: requirements and European Standards.
-An assembly of linked parts or components, at least one of which
moves, with the appropriate actuators, control and power circuits, STEP VI: Manufacturers whose equipment is subject to an EC-
etc., joined together for specific application, in particular for the Type examination by a Notified Body must:
processing, treatment, moving or packaging of material. 1) Hire a Notified Body to perform an EC-Type examination.
This usually means submittance of the completed
OR Technical File for evaluation by the Notified Body and an
ON-SITE visit to check machine performance against the
-An assembly of machines which, in order to achieve the same end, Technical File content.
are arranged and controlled so that they function as an integral
2) Issue a Declaration of Conformity once an EC-Type
whole.
examination Certificate has been issued by the Notified
Body.
OR 3) Affixing of the CE-mark + the 4 digit Notified Body
Interchangeable equipment modifying the function of a machine, number to the machine.
which is placed on the market for the purpose of being assembled 4) Keeping the Technical File available for up to 10 years
with a machine or a series of different machines or with a tractor by following production of the last machine ever made so
the operator himself in so far as this equipment is not a spare part that it can always be made available to a European
or a tool. Competent Authority if requested.
Compliance in Eleven Logical Steps: STEP VII: A manufacturers Declaration of Conformity

signed by the Competent Person must be shipped with each
machine. The person signing this declaration holds personal as
STEP 1: Before CE-marking machinery the manufacturer i.e. well a corporate liability for the validity of the declaration being
the one party who takes responsibility for the design and made. The credibility of the Technical File determines whether
manufacture of a machine and puts its name on the name plate, such a declaration can be made.
must conform to all applicable European Directives.
STEP VIII: Be aware of, or designate, who may act as your
STEP II: Determine if your machine falls within the scope of companys European Authorized Representative, this may be
Annex IV of the Machinery Directive and requires the certification of your distributor, agent, importer, end-user or independent party in
a Notified Body. Check list here: www.ce-mark.com/iv.html . the EU.
STEP III: Determine if your machine falls outside the scope of STEP IX: Comply with all other Directives that apply to your
Annex IV of the Machinery Directive and can be self-certified. 93% machinery, most often these are:
of all machinery may be self-certified. Details at www.ce-
mark.com/self.html . Electromagnetic Compatibility (EMC)
STEP IV: Prepare a Technical File describing and All appliances, equipment, machinery and installations containing
documenting how the machine(s) comply with the (48) Essential electrical and electronic components that are liable to generate or
requirements of Annex I of the Machinery Directive. European be susceptible to electromagnetic interference.
standards can be used as a guideline when meeting specific www.ce-mark.com/emcdir.html
requirements but their use is voluntary and international or national
standards can also be used. Low Voltage Directive (LVD)
Building a Technical File is not only mandatory, but also good
insurance, and relies heavily on the completion of a through Hazard Electrical equipment designed for use with a Voltage rating
and Risk Analysis. Satisfying the requirements of Annex I may between 50V and 1000V for alternating current and between 75V
require the implementation of engineering changes. More at: and 1500V for direct current. www.ce-mark.com/LVD.html
www.ce-mark.com/mach.html and www.ce-mark.com/atf.htm . Go To Page 2 www.ce-mark.com/mach2.pdf

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Compliance in Eleven Logical Steps: STEP VII: A manufacturers Declaration of Conformity

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