The scope of the Machinery Directive includes the following definition for a machine:

An assembly of machines which, in order to achieve the same end are arranged and controlled so that they function as an integral whole.

In other words, a complex assembly. An entire production facility can be classed as ‘a complex assembly of machines’ and is therefore subject to the requirements of the Directive.

Even where the complex machinery is assembled by the end-user for his own production facility and will never be sold into the marketplace, there is still the legal obligation to comply with the Essential Health and Safety Requirements (EHSRs), compile a Technical File and affix the CE Marking.

There are two common scenarios for ‘complex assemblies’

1) New Machinery

Two or more new machines are linked to form an assembly. Each machine is accompanied by Declarations of Conformity or Incorporation to show compliance with the Directive. The Machinery Directive requires a ‘responsible person’ to ensure that the complex assembly complies and is safe. Practically, this means carrying out Risk Assessment, ensuring compliance with the EHSRs, producing a Technical File and affixing the CE Marking.

2) Existing machinery

A production facility is updated by linking a series of existing machines that have been in service for some years. These machines may bear CE Marking or predate the CE Marking regulations.

The Machinery Directive requires a ‘Responsible Person’ to ensure that the complex assembly complies as far as the state of the art allows, and is safe. This includes providing a Technical File, affixing the CE Marking and providing a Declaration of Conformity.

Where a company is bringing together equipment and machinery from a variety of sources, Laidler Associates can assist with all stages of the CE Marking process using a practical and cost effective approach.

There are 5 main steps to CE Marking a machine. They are:

• Risk Assessment
• Essential Health and Safety Requirements (EHSR)
• Technical File
• Declaration of Conformity
• Affix CE Marking

For most machinery (other than those listed in Annex IV of the Directive), the compliance route is Self-Declaration. Machinery that is listed in Annex IV has to be approved by a Notified Body.

Laidler Certification is a Notified Body for the Machinery Directive and can complete the conformity assessment procedure

Laidler Associates can assist with all stages of the CE Marking process including:

• Providing advice and information
• Carrying out inspections
• Providing Risk Assessments
• Ensuring compliance with the EHSRs and EN Standards
• Compiling Technical Files
• Issuing the Declaration of Conformity
• Acting as the Authorised representative within the EEA

For suppliers based outside of the EEA, Laidler Associates can act as the ‘responsible person’ within the EEA by holding a copy of the Technical File and signing the Declaration of Conformity on their behalf.