Medical Devices (MDR)

CE certification in accordance with the Medical Devices Regulation 2017/745.

Machinery Directive 2006/42/EC

The Machinery Directive is a European Directive which defines product requirements that must be upheld by manufacturers and other economic operators for the purpose of placing machinery and installations and other products covered by the scope of this Directive on the market and/or put these into use within Europe. The product requirements are defined by so-called essential safety and health requirements. Manufacturers and other economic operators planning to place machinery and installations on the market or put these into use within Europe must meet these requirements. Only after all applicable product requirements of the Machinery Directive and other relevant CE product requirements have been met, can the CE marking be affixed to the machinery and installations and can the machinery and installations be freely placed on the market within the European Union.

The Machinery Directive applies to machinery, installations, interchangeable equipment, safety components, lifting accessories, chains, ropes and webbing, removable mechanical transmission devices and partly completed machinery.

A number of products are also excluded from the Machinery Directive. These include agricultural and forestry tractors, switchgear and machinery installed on seagoing vessels and mobile offshore units.


New machinery regulation

Main changes that manufacturers and other economic operators should take into account.

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Machinery safety - Our Expertise

Our machinery safety experts at Certification Company have the necessary skills and expertise at their disposal, in order to fully perform the entire CE certification procedure of your machine(s) on your behalf. Our specialists are TÜV certified, accredited safety experts and are capable of performing a complete conformity assessment procedure in accordance with the Machinery Directive and any other applicable CE product regulations. You can rest assured that your machinery or installation will be assessed professionally and impartially in order to place it legally approved on the market.

  • CE conformity assessment

    Carry out complete CE conformity assessment procedures.

  • Product classification

    Classification of your machinery to determine whether it falls within the scope of the Machinery directive.

  • Risk analyses

    Carry out normalized risk analyses and risk assessments (EN-ISO 12100:2010)

  • Tests and Inspections

    Perform tests, measurements and inspections (also on site)

  • User manual

    Verify or draw up instruction manual

  • Technical Files

    File management of your Technical Documentation

  • EU Declaration of Conformity

    Draw up EU Declaration of Conformity

  • Consultancy

    Provide advice on affixing the CE marking on your machinery and installations

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Six steps to CE certification of electronic equipment (EMC)

  • 01 Product classification

    Determine whether the product falls within the scope of the EMC Directive.

  • 02 Economic operator classification

    Determine the role of the economic operator within the EMC.

  • 03 Conformity procedure

    Carry out EMC measurements based on European (harmonised) standards.

  • 04 Technical Documentation

    Compile the technical documentation (including instruction manual) based on which the conformity of the product can be assessed.

  • 05 EU Declaration of Conformity

    Draw up the EU Declaration of Conformity and confirm compliance of the product with the EMC Directive (and any other relevant CE harmonisation legislation).

  • 06 CE marking

    As soon as the product complies with the EMC Directive, the CE marking will be affixed to the electrical or electronical product.

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