Understanding Each Directive:

• The Machinery Directive (MD) covers “Product Safety” for products with a primary
• hazard that is “mechanical” – injury hazards caused by moving parts that involvecrushing, smashing, cutting, etc. This Directive applies primarily to production line and
  large industrial equipment – things that could seriously injure or kill a user (the types of
  hazards covered by OSHA workplace requirements in the US).
• The Low Voltage Directive (LVD) covers “Product Safety” for products where the primary
  hazard is “electrical” – shock hazards, energy hazards, electrical fire hazards, etc. This
  Directive applies to electrical products typically covered by UL standards in the US =
  computer and peripherals, office appliances, TV’s, home appliances, laboratory
  equipment, etc.

Determining Factors:

• Machine Definition: Before you consider the Machinery Directive, does your product meet the definition of a “machine” as provided in the Directive? The definition of a
  machine is “an assembly, fitted with or intended to be fitted with a drive system other
  than directly applied human or animal effort, consisting of linked parts or components, at
  least one of which moves”. If your product doesn’t meet this definition, the MD doesn’t
  apply.
• Primary Hazard: What is the primary hazard from the device? If it is an exposed
  mechanical hazard (i.e. moving arm, press that crushes, saw blade, etc.) then the
  Machinery Directive is the correct choice. If the primary hazard is from the electrical
  circuitry, the LVD is the choice.

• Standard Lists: Both of these Directives state that if there are applicable standard(s)
  listed under the Directive and your product complies with the standard(s), then your
  product complies with the Directive. Review the List of Standards under each Directive =
  is there a standard listed under one of the Directives that clearly applies to your product?
  If so, that is the Directive/Standard to apply.

Grey Area: Sometimes it’s still not clear which Directive applies to a product. Here are
some additional considerations to help in reaching a decision.

1) LVD – Mechanical Hazards: The LVD doesn’t prohibit products that have mechanical
hazards. Standards listed under the LVD anticipate and include requirements for lower
risk mechanical hazards.

• ‍

  To demonstrate this, consider EN61010-1 under the LVD. EN61010-1 includes requirements
  for mechanical hazards – for products that have low risk mechanical hazards. The
  determining factor is as stated in EN61010-1 = if the requirements of EN61010-1 are
  adequate to evaluate the mechanical hazards for the product in question (sharp
  edges/points, stability, access with probes to minor moving parts, enclosure push, etc.), then
  EN61010-1 is appropriate. If the hazards are beyond the scope of the standard, you need to
  use Risk Assessment based requirements (i.e. use the Machinery Directive).

2)  Common Standard: The Standard for the Electrical Safety of Machines, EN60204-1, is on
both the MD and the LVD Standards List. Therefore, by using EN60204-1 under the MD,
you can also declare compliance with the LVD for this standard.

3)  Self-Declaration: With the exception of the high hazard product types listed in Annex IV of
the Machinery Directive, both Directives are “Self-declaration” – this means that the
manufacturer decides which Directives and Standards apply. As a result, no two CE
product reviews will be the same. And, as long as you have sound rationale for your
choice, documented in your Technical Construction File, there is no “wrong” answer.

4)  LVD is Easier: The LVD is a much easier process in determining compliance. There is
much more involved with the MD. The MD requires a Risk Assessment, the Annex I review
in the MD is extensive and requires a very detailed report, and there are many more
standards listed under the MD (harder to determine what standards apply and more likely
that multiple standards will apply).

5)  Customer requests for MD: Consider where your product will be used. It is common for
people purchasing equipment to be used in a Production environment to require
compliance with the Machinery Directive. Unfortunately, use of a product on the production
floor is not the deciding factor on what directive applies to the product. If your product will
be used on the production floor and it meets the definition of a machine in the MD, you
may be better off using the Machinery Directive. Otherwise, you may have to frequently
explain why you didn’t use the MD. This is especially true if you have a competitor that
used the MD and who might try to use that against you with your customers.

6)  Electrical & Mechanical Hazards: Regardless of which of the two directives you apply,
both aim to achieve the same objective = adequate electrical and mechanical hazard
protection. If your product has only a low level of mechanical hazard risk, the LVD is the
likely choice. If your product has a higher level of mechanical hazard risk, the MD is the
better choice.

7)  Apply Both Directives? In general, for an individual product, you should select the LVD or
the MD. Article 1, Clause 2, item k of the Machinery Directive specifies that electrical
products covered by the LVD are exempt from the Machinery Directive. Note that if you
build a system that includes different types of products, each product is evaluated to the
CE Directives applicable to that product. For example, a computer is evaluated to the LVD
even if it is mounted to a machine that falls under the MD. Do not need to try and source
a computer that complies with the MD, because it doesn’t exist – the computer does not
meet the definition of a machine. The computer should comply with the LVD.

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including the Machinery Directive & the Low Voltage Directive

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