obelis logo

Obelis European Authorized Representative Center

"CE Marking Consultants with a Reputation for Excellence"

You are here:

Compliance with the MSD 98/37/EC

The letters “CE” on a product are the manufacturer’s claim that the machine meets the essential health and safety requirements (ESHR’s) of the Machinery Directive and may also include the Low Voltage Directive, EMC Directive, Pressure Directive, etc., etc. The ESHR’s for machinery take into account potential dangers to operators and other persons using or affected by the machine. ESHR’s include, materials used in the construction; lighting; controls; stability; fire; noise; vibration; radiation; emission of dust, gasses etc.; maintenance and documentation. Compliance with the appropriate Harmonized European Standards (“Euro Norms” or EN’s) is recognized as meeting with the appropriate ESHR’s.

Before a product is placed on the market the following must happen:

  • The manufacturer must put together a Technical Construction File, a document which makes it possible to assess whether the product complies with the directive
  • The manufacturer or the authorized representative must draw up a “Declaration of Conformity” (or for partially completed equipment, a “Declaration of Incorporation”)
  • The manufacturer or the authorized representative must affix the CE mark

For non-EU manufacturers: Appoint a European Authorized Representative established within the European Community.

Non-Compliance

The directive portrays European Law enforced within the European Economic Area (EEA); non-compliance with the directive’s requirements will result in the removal of the product from the EEA and the revoking of the CE marking affixed on the machinery.

 

obelis people image

Search

Client Access



Need an EAR?

This text will be replaced
Take the Fast Lane
 

One Link One Solution

one link one solution

Obelis' World Network of Regulatory Advisors and International Representation

 

Obelis Global Team

Obelis' Worldwide Representatives

 

GiDoS - Green Regulatory Center

Our sister company GiDoS s.p.r.l. provides REACH, WEEE, RoHS and P&PW compliance services

Visit GiDoS.net

Newsletter

» Sign up for our newsletter to receive our weekly publications on EU directives, our news and events, as well as updates to our web site.