Path to EU Market Entry for Machinery: Compliance

Path to EU Market Entry for Machinery: Compliance

Under Article 12 of the Machinery Directive there are three routes for conformity assessment:

  1. The procedure for assessment of conformity with internal checks on the manufacture of machinery, provided for in Annex VIII,
  2. The EC type-examination procedure provided for in Annex IX, plus the internal checks on the manufacture of machinery provided for in Annex VIII, point 3,
  3. The full quality assurance procedure provided for in Annex X.

The second and third conformity assessment route require the involvement of a Notified Body.

Essential Requirements

The essential health and safety requirements (EHSRs)- set out in the Annex I of the MD- identify the potential hazards which may arise from the design and operation of machinery and give instructions on what hazards must be avoided. Therefore, they are applicable when the hazard concerned is present.

The EHSs range from general remarks common to all products to more specific requirements for certain categories of machinery.

They are presented in six sections :

  1. General remarks common to all type of machinery - such as safety principles, design to facilitate handling, ergonomics, control systems, protection against mechanical hazards, other hazards such as from electricity and other forms of energy, temperature, fire and explosion, emissions from noise, vibration, radiation and hazardous substances, maintenance, cleaning and information and markings / warnings
  2. Requirements applicable to certain classes of machinery- such as foodstuffs, cosmetics and pharmaceuticals;
  3. Requirements to offset hazards due to the mobility of machinery;
  4. Requirements to offset hazards to lifting operation;
  5. Requirements for machinery intended to work underground;
  6. Requirements for machinery lifting persons.

With the exception of the key EHSRs (1.1.2 Principles of safety integration, 1.7.3 Marking and 1.7.4 Instructions) which are always applicable, the EHSRs are applicable when the manufacturer’s risk assessment shows that the hazard concerned is present for a given model of machinery used under conditions foreseen by the responsible person or in foreseeable abnormal situation.

Then, the manufacturer needs to carry out a risk assessment- interactive process set out in the Annex I of the Directive- and compliance procedure for the risk areas associated to the relevant ESHRs. However, taking into account the state of the art, it may not be possible to meet all of the objectives set by the EHSRs. Where this is not possible, machinery must, as far as possible, be designed and constructed with the purpose of approaching the objectives of the EHSRs.

Harmonized Standard

Machinery manufactured in conformity with a harmonized standard – which have been published in the Official Journal of the European Union- shall be presumed to comply with the essential health and safety requirements covered by such a harmonized standard.

It there are no harmonized standard or they are missing or they do not exist for a product, it may be used national or international standards or specification but conformity with EHRS must be proved.

Due to the broad number of standards required to cover the full range of machines within the scope of the Directive, the European Harmonized Standards have been hierarchy classified into three types A, B and C.

Technical Documentation

The manufacturer compiles the technical documentation, which makes it possible to assess whether the machinery complies with the requirements of the Directive It contains at least the elements set out in the Annex VII.

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