Annex VII - Technical file for machinery - machinery directive 2006/42/EC

The text in RED color is the amended or added text in comparison with the former 98/37/EC machinery directive.

ANNEX VII –

A. Technical file for machinery

This part describes the procedure for compiling a technical file. The technical file must demonstrate that the machinery complies with the requirements of this Directive. It must cover the design, manufacture and operation of the machinery to the extent necessary for this assessment. The technical file must be compiled in one or more official Community languages, except for the instructions for the machinery, for which the special provisions of Annex I, section 1.7.4.1 apply.

1. The technical file shall comprise the following:

(a) a construction file including:

- a general description of the machinery,

- the overall drawing of the machinery and drawings of the control circuits, as well as the pertinent descriptions and explanations necessary for understanding the operation of the machinery,

- full detailed drawings, accompanied by any calculation notes, test results, certificates, etc., required to check the conformity of the machinery with the essential health and safety requirements,

- the documentation on risk assessment demonstrating the procedure followed, including:

(i) a list of the essential health and safety requirements which apply to the machinery,

 (ii) the description of the protective measures implemented to eliminate identified hazards or to reduce risks and, when appropriate, the indication of the residual risks associated with the machinery,

- the standards and other technical specifications used, indicating the essential health and safety requirements covered by these standards,

- any technical report giving the results of the tests carried out either by the manufacturer or by a body chosen by the manufacturer or his authorised representative,

- a copy of the instructions for the machinery,

- where appropriate, the declaration of incorporation for included partly completed machinery and the relevant assembly instructions for such machinery,

- where appropriate, copies of the EC declaration of conformity of machinery or other products incorporated into the machinery,

- a copy of the EC declaration of conformity;

(b) for series manufacture, the internal measures that will be implemented to ensure that the machinery remains in conformity with the provisions of this Directive.

The manufacturer must carry out necessary research and tests on components, fittings or the completed machinery to determine whether by its design or construction it is capable of being assembled and put into service safely. The relevant reports and results shall be included in the technical file.

2. The technical file referred to in point 1 must be made available to the competent authorities of the Member States for at least 10 years following the date of manufacture of the machinery or, in the case of series manufacture, of the last unit produced.

The technical file does not have to be located in the territory of the Community, nor does it have to be permanently available in material form. However, it must be capable of being assembled and made available within a period of time commensurate with its complexity by the person designated in the EC declaration of conformity.

The technical file does not have to include detailed plans or any other specific information as regards the sub-assemblies used for the manufacture of the machinery unless a knowledge of them is essential for verification of conformity with the essential health and safety requirements.

3. Failure to present the technical file in response to a duly reasoned request by the competent national authorities may constitute sufficient grounds for doubting the conformity of the machinery in question with the essential health and safety requirements.

Comment : A VII-1

1. The technical file has been renamed. While he was called "technical construction file" in the old Machinery Directive 98/37/EC, it is now called "technical file" and includes a "construction file" and other elements.

2. The contents of this technical file is similar for all the machines and safety components, regardless of the certification procedure followed. The old machinery directive 98/37/EC defined a different content in Annexes V Chapter 3, and Annex VI Chapter 2, second indent.

3. The documentation associated with the risk assessment must be provided (4th paragraph a) - two standards help to achieve risk assessment (ISO / TR 14121-1/2).

4. Copies of declaration of incorporation included in the assembly of partly completed machinery and EC declaration of conformity of  the machine instructions must be included in the "technical file".

5. The term "where appropriate" is interpreted by most as notified bodies in fact as mandatory.

6. together with the relevant reports and pertinent results that are included in the technical file.

Original Comment : A VII-1

1. Le dossier technique a été rebaptisé. Alors qu’il s’appelait « dossier technique de construction » dans l’ancienne directive machines 98/37/CE, il se nomme désormais « dossier technique » et comprend un « dossier de construction » et d’autres éléments.
2. Le contenu de ce dossier technique est similaire pour toutes les machines et composants de sécurité, quelle que soit la procédure de certification suivie. L’ancienne directive directive 98/37/CE définissait un contenu différent dans les annexes  V chapitre 3 a, et dans l’annexe VI chapitre  2 deuxième tiret.
3. La documentation relative à l’évaluation du risque doit être fournie (4^ème alinéa de a) – deux normes aident à la réalisation de l’évaluation du risque (ISO/TR 14121-1/2).
4. Les copies des déclarations d'incorporation incluses dans les notices d'assemblage des quasi-machines et déclaration CE de conformité de la machine doivent être inclues dans ce "technical file".
5. Le terme « le cas échéant » est interprété par la plupart des organismes notifiés comme étant en fait obligatoire.
6. Ainsi que les rapports et résultats pertinents qui sont joints au dossier technique.

B. Relevant technical documentation for partly completed machinery

This part describes the procedure for compiling relevant technical documentation. The documentation must show which requirements of this Directive are applied and fulfilled. It must cover the design, manufacture and operation of the partly completed machinery to the extent necessary for the assessment of conformity with the essential health and safety requirements applied. The documentation must be compiled in one or more official Community languages.

It shall comprise the following:

(a) a construction file including:

- the overall drawing of the partly completed machinery and drawings of the control circuits,

- full detailed drawings, accompanied by any calculation notes, test results, certificates, etc., required to check the conformity of the partly completed machinery with the applied essential health and safety requirements,

- the risk assessment documentation showing the procedure followed, including:

(i) a list of the essential health and safety requirements applied and fulfilled,

(ii) the description of the protective measures implemented to eliminate identified hazards or to reduce risks and, where appropriate, the indication of the residual risks,

(iii) the standards and other technical specifications used, indicating the essential health and safety requirements covered by these standards,

(iv) any technical report giving the results of the tests carried out either by the manufacturer or by a body chosen by the manufacturer or his authorised representative,

(v) a copy of the assembly instructions for the partly completed machinery;

(b) for series manufacture, the internal measures that will be implemented to ensure that the partly completed machinery remains in conformity with the essential health and safety requirements applied.

The manufacturer must carry out necessary research and tests on components, fittings or the partly completed machinery to determine whether by its design or construction it is capable of being assembled and used safely. The relevant reports and results shall be included in the technical file.

The relevant technical documentation must be available for at least 10 years following the date of manufacture of the partly completed machinery or, in the case of series manufacture, of the last unit produced, and on request presented to the competent authorities of the Member States. It does not have to be located in the territory of the Community, nor does it have to be permanently available in material form. It must be capable of being assembled and presented to the relevant authority by the person designated in the declaration for incorporation.

Failure to present the relevant technical documentation in response to a duly reasoned request by the competent national authorities may constitute sufficient grounds for doubting the conformity of the partly completed machinery with the essential health and safety requirements applied and attested.

Comment : A VII-2

This appendix is new. Its contents is almost identical with the requirements set out in that Annex for machines and safety components but with a hint as to the name of the technical file.

This refers to the "Relevant technical documentation" and not the "technical file".

Original Comment : A VII-2

Cette annexe est nouvelle. Son contenu est quasi identique avec les exigences définies dans la même annexe pour les machines et composants de sécurité avec toutefois une nuance quant à l’appellation de ce dossier.

Il s’agit de la « Documentation technique pertinente » et non pas du « dossier technique ».