AR - Machinery


Authorised Representative for The Machinery Directive & UK Supply of Machinery (Safety)Regulations

Manufacturers placing products on the EU or UK market have specific obligations under the EU Directives and UK Regulations. These include appointing and Authorised(where the manufacturer is not established in the EU or UK)

EU requirements: Directive 2006/42/EC of the European Parliament and of the councilof17 May 2006on machinery, aims to ensure that only safe products are made available to consumers. It defines a number of requirements for Manufacturers and distributors of products to ensure that products are safe, consumers are informed of any risks associated with products and dangerous products can be removed.

UK requirements: The UK’s Supply of Machinery (Safety)Regulations 2008aims to ensure that only safe products are made available to UK consumers. This defines a number of requirements for Manufacturers and distributors of products to ensure that products are safe, consumers are informed of any risks associated with products and dangerous products can be removed.

What products are in the scope of the Regulations?

The regulations apply to:

  • Machinery
  • Interchangeable equipment
  • Safety components
  • Lifting accessories
  • Chains, ropes and webbing
  • Removable mechanical transmission devices
  • Partly completed machinery

However there are also some specific exclusions.

Changing your Authorized Representative.

 

To be compliant, the manufacturer should address the following aspects:

The date of termination of the outgoing Authorized Representative and the date of start of the incoming one.

The date until which the manufacturer can show the outgoing AR on the information or promotional material.

The transfer of documents, including confidentiality aspects and property rights.

The obligation to the outgoing Authorized Representative to send to the manufacturer or incoming Authorized Representative, any complaints or reports from healthcare professionals and patients or users about suspected incidents related to the device for which it has been designated.

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