Secure storage for your technical files

Regulation 2019/1020 on market surveillance identifies the following Directives and Regulations in Annex I. Products within this list require technical information to be held by an importer, fulfilment centre or Authorised Representative to be able to continue to supply the product or good into the EU from July 16th 2020. The Directive and Regulation list is below, with Authorised Representative duties identified. 

Please Note: We do not act as Authorised Representative for Medical Devices Directives or WEEE.

The manufacturer remains responsible for the safety and compliance of the machinery or products supplied.

Machinery

Directive 2006/42/EC of the European Parliament and of the Council of 17 May 2006 on machinery, and amending Directive 95/16/EC (OJ L 157, 9.6.2006, p. 24);

The Responsibility of an Authorised Representative is less clearly defined than some other Directives. To clarify our services, the references throughout the Directive text are '... the manufacturer or his authorised representative ...' We have defined the following from Article 5.

  1. The manufacturer shall ensure that the machinery or product satisfies the relevant essential health and safety requirements set out in Annex I;
  2. The Authorised Representative shall ensure that the technical file referred to in Annex VII, part A is available and adequate;
  3. The manufacturer shall provide, in particular, the necessary information, such as instructions;
  4. The manufacturer shall carry out the appropriate procedures for assessing conformity in accordance with Article 12;
  5. The manufacturer shall draw up the EC declaration of conformity in accordance with Annex II, part 1, Section A and ensure that it accompanies the machinery;
  6. The manufacturer shall affix the CE marking in accordance with Article 16.

Article 13 has similar requirements for Partly Completed Machinery.

Hold Tech Files will act as Authorised Representative, and will review the Technical Files, provide a report on their suitablity, and when acceptable, act as Authorised Representative. 

Directive 2000/14/EC of the European Parliament and of the Council of 8 May 2000 on the approximation of the laws of the Member States relating to the noise emission in the environment by equipment for use outdoors (OJ L 162, 3.7.2000, p. 1); 

Responsibility of an Authorised Representative - The manufacturer, or his authorised representative established in the Community, of equipment referred to in Article 2(1) shall keep a specimen of the EC declaration of conformity for 10 years from the date on which the equipment was last manufactured, together with the technical documentation as provided for in Annex V point 3, Annex VI point 3, Annex VII point 2, Annex VIII points 3.1 and 3.3.

Directive 2014/33/EU of the European Parliament and of the Council of 26 February 2014 on the harmonisation of the laws of the Member States relating to lifts and safety components for lifts (OJ L 96, 29.3.2014, p. 251);

Responsibility of an Authorised Representative The obligations laid down in Article 7(1) or in Article 8(1) and the obligation to draw up technical documentation referred to in Article 7(2) or in Article 8(2) shall not form part of the authorised representative’s mandate. An authorised representative shall perform the tasks specified in the mandate received from the manufacturer or the installer. The mandate shall allow the authorised representative to do at least the following:

(a)

keep the EU declaration of conformity and, where applicable, the approval decision(s) relating to the manufacturer’s or the installer’s quality system, and the technical documentation at the disposal of the national market surveillance authorities for 10 years after the safety component for lifts or the lift has been placed on the market;

(b)

further to a reasoned request from a competent national authority, provide that authority with all the information and documentation necessary to demonstrate the conformity of the safety components for lifts or the lift;

(c)

cooperate with the competent national authorities, at their request, on any action taken to eliminate the risks posed by the safety component for lifts or the lift covered by the authorised representative’s mandate.

 

Regulation (EU) 2016/424 of the European Parliament and of the Council of 9 March 2016 on cableway installations and repealing Directive 2000/9/EC (OJ L 81, 31.3.2016, p. 1);

Responsibility of an Authorised Representative - The obligations laid down in Article 11(1) and the obligation to draw up technical documentation shall not form part of the authorised representative's mandate. An authorised representative shall perform the tasks specified in the mandate received from the manufacturer. The mandate shall allow the authorised representative to do at least the following:

(a)

keep the EU declaration of conformity and the technical documentation at the disposal of national market surveillance authorities for 30 years after the subsystem or the safety component has been placed on the market;

(b)

further to a reasoned request from a competent national authority, provide that authority with all the information and documentation necessary to demonstrate the conformity of the subsystem or the safety component;

(c)

cooperate with the competent national authorities, at their request, on any action taken to eliminate the risks posed by subsystems or safety components covered by the authorised representative's mandate.

 

Legal Requirements

The Machinery Directive 2006/42/EC requires that 'there must be a person authorised to compile a Technical File who must be established in the Community'. This person is responsible for making the Technical File available if required by EU Health and Safety Authorities. The reason is to ensure that Technical Files can be made available when required.

The 'person' can be a company that is based in the EU, it can be a subsidiary company of a global parent company, it can be an authorised representative. A Declaration that does not list the person authorised to compile the Technical File iis not compliant with the Machinery Directive and the compliance is difficult to prove.

Extracts from the Guide to application of the Machinery Directive 2006/42/EC Edition 2.1 – July 2017: -

Words in italics are from the Directive text, and a legal requirement. Comments below are from the Guide, in normal text.

Machinery Directive 2006/42/EC Annex II 1 A 

The EC declaration of conformity must contain the following particulars: …

  1. name and address of the person authorised to compile the technical file, who must be established in the Community;

All machinery manufacturers must indicate the name and address of the person authorised to compile the technical file. That person is a natural or legal person established in the EU who has been entrusted by the manufacturer with the task of assembling and making available the relevant elements of the technical file in response to a duly reasoned request from the market surveillance authorities of one of the Member States. Essentially there must be a contact point in the EU for non-EU manufacturers. It is also required by other EU legislation like the Outdoor Noise Directive 2000/14/EC.

ANNEX VII A (continued)

  1. 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.

Section 3 of Annex VII A states that failure to present the technical file in response to a duly reasoned request may constitute sufficient grounds for doubting the conformity of the machinery in question. Failure to present the technical file is not proof of the nonconformity of the machinery but, if the manufacturer does not communicate the relevant elements of the technical file, the market surveillance authorities are entitled to decide what action to take on the basis of whatever other evidence is available to them.

Format of a Technical File

There is no specific format for a Technical File required by the EU or UK Authorities, however it must contain all relevant information.

Key documents are the Essential Health and Safety Requirement (EHSR) report, Risk Assessment, Functional Safety Validation Report, along with drawings, calculations and test reports showing the equipment complies with the Directive, and any other relevant Directives such as EMC, PED or ATEX.

Contents of a Technical File

File

From the Machinery Directive 2006/42/EC

ANNEX VII

  1. Technical File for Machinery

This describes the procedure for compiling a technical file. The technical file must demonstrate that the machinery complies with the requirements of the 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.

 

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.

How long should the Technical File be Held

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.

For ease of reading by relevant authorities, it is suggested that PDF format should be used, as this is likely to continue to be able to be read in the future. The file has to be available for at least ten years, more if it is for series machinery, so needs to be able to be read by Authorities, otherwise they may determine it is insufficient. 

It can be in different folders or sections if the file is large. Single PDF files of more than 1,000 pages can be difficult to read, and slow to open.

There is a sample Technical File Index here. Technical File Index. There may be sections that are not applicable, this should be identified. 

There are a number of software packages available for compiling Technical Files for the Machinery Directive.

We recommend COMPLIANCE Risk Software. This allows EHSR's to be addressed, Risk Assessment to be carried out and pictures linked to hazards to show the before and after. It will generate a Declaration of Incorporation or Conformity, and allows multiple products to be maintained. A free demonstration can be downloaded and tested before buying.