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Machinery Directive (MD) EU legislation and harmonized standards research

This section guides you through the EU legislatory and harmonized standards research specifically relevant for the Machinery Directive 2006/42/EG.

If based on the information provided in the previous research step the Machinery Directive has been deemed applicable to your product, it will be displayed offset to the right in the process overview.

There are five steps with separate groups of questions and simple checklists to workthrough.

The choices in each section influence those following on, thereby filtering, simplifying and accelerating this otherwise complex process for you.

  • Section 1 - The exclusion questions. Firstly, an assessment will first be made as to whether the Machinery Directive 2006/42/EG is applicable to your product or excluded.
  • Section 2 - The category questions. Next, the type of machine or "category" will be more closely identified.
  • Section 3 - Annex I safety requirements preselection. By answering the subsequent Section 3 questions CERTAIN will preselect which sections of the Machinery Directive Annex I may be relevant and applicable for your product.
  • Section 4 - Annex I section confirmation. You then confirm or reject those Annex I preselections in step 4.
  • Section 5 - Harmonized Standards selection. CERTAIN finally lists then those applicable standards for you to review and confirm your final harmonized standards list.

⚠️ Always save your valuable research!​

You be required to work though and save five sections to complete this process step. CERTAIN regularly records your progress in the background, but do make sure to consciously save your work before leaving this area.

You may reevaluate and reselect your choices and amend your answers at any time in the future.

1. The directive(s) identified are displayed offset on the right​

2. Click on the bullet - Machinery Directive 2006/42/EG​

You will be guided through the research step by step.

Researching the regulations and harmonized standards​

3. Five step research​

There are five sections here to complete. They are visible at the top of the screen.

Work your way through each section in turn until all five are answered.

When finished be sure to save your choices.

Section 1 - Machinery Directive exclusion questions​

4. Start at step 1 - the exclusion questions​

The first will ask a selection of questions to assess whether your product is in fact covered by or excluded from the Machinery Directive 2006/42/EG

The Machinery Directive explicitly excludes certain types of products from its scope.

💡 Need more background information?​

If you are unsure about the question and need additional support there are two dropdown information buttons which will help you.

They include:

  • The original texts from the Machinery Directive document.
  • Additional helpful CERTAIN support explanations from our team

Just click on the arrows below the questions to view them.

5. Viewing a detailed explanation​

We have provided additional background information here to assist you.

6. Viewing the original Directive text​

We have also included an excerpt from the original Directive text here for reference.

7. Complete the checklist​

Answer each of the questions with Yes or No.

All questions must be answered.

8. When you are finished click on next step​

9. Exclusion from the Machinery Directive​

If the selections you have made indicate that your product is excluded from the Machinery Directive you will see the following window and message below.

The applicable Machinery Directive clause that led to the exclusion can be viewed using the dropdown arrow.

You then have the choice of ending the research and returning to the Product Overview or updating your selections in the checklist.

If you return to the Product Overview or CERTAIN dashboard, you will also see the product as being excluded from the Machinery Directive in the list.

10. Preparing an exclusion document​

If needed, CERTAIN will generate an official exclusion document for you.

An exclusion document may be of importance to you if are officially requested to explain or justify why the Machinery Directive does not apply to your product.

Click on CE Documentation.

11. Create the exclusion document​

From the CE Documentation screen, click on Create complete documentation.

12. Select PDF preview​

The document will be shown ready to download on the right. Click on preview to review it.

13. Exclusion document preview​

Review and download or print the document as needed.

⚠️ CERTAIN Scope - The Machinery Directive and the Low Voltage Directive​

In this version, CERTAIN is concerned with machines and electrical equipment and the application of the Machinery Directive 2006/42/EG and the Low Voltage Directive 2014/35/EU.

It is important to note that even though your product may be excluded from these named directives may nevertheless fall under the scope of other directives or forms of product legislation which could require a CE Marking or other forms of evaluation and declaration.

Section 2 - Machine Category​

14. Product Category Questions​

Does your product fall into a special machine category?

Annex I Section 2 of the Machinery Directive 2006/42/EG also defines different categories of machines, some of which are subject to alternative more stringent legislation.

Please progress through the list of questions, answering with Yes or No. CERTAIN will ascertain whether or not the product product falls into one of these special categories or not.

This will determine the extent of product evaluation needed, whether for example a first piece qualification or ongoing quality checks within the framework of a certified QMS are required. Alternatively your machine may necessitate the support of an external notified body.

In this Section CERTAIN will identifies whether a self- assessment is possible for your product or whether further assessment or quality control measures will need to be demonstrated for the CE marking.

15. Confirm your answers with Yes or No​

16. Need some more help?​

Throughtout these sections, if you need additional explanatory information or wish to view the original Regulation text, click on the dropdown arrows below the question.

17. When you are finished click on next step​

All questions must be completed to continue.

Section 3 - Annex I preliminary selection​

💡 Annex I - The checklist​

(Article 5 Section 1(a))

"Before placing machinery on the market and/or putting it into service, the manufacturer or his authorised representative shall:

(a) ensure that it satisfies the relevant essential health and safety requirements set out in Annex I "

Annex I outlines the essential requirements that products must meet to be CE marked. These essential requirements are specific to each product category and cover aspects such as safety, performance, design, and construction. Annex I effectively serves as a checklist or a "harmonized standard" for the CE conformity assessment of products.

18. Annex I questions​

This important step in the conformity assessment is to understand which aspects of Annex I actually apply to your product.

By answering the following carefully selected questions, CERTAIN will help you to determine quickly which sections of Annex I are important, may be relevant and must be adhered to.

CERTAIN will subsequently use this information to suggest the applicable harmonized standards relevant for the conformity of your machine.

Please progress through the list of questions, answering them all with Yes or No.

19. Complete the questionaire​

As with the previous questionaires, explanatory text may be reviewed by using the dropdown arrow

20. When you are finished click on next step​

Section 4 - Annex I relevant sections​

21. Annex I - Choosing the relevant sections​

Based on your previous selections CERTAIN prepares a filtered list of Annex I points which are deemed relevant to your product and its safety requirements.

Please go through all the suggested sections and confirm those that you believe to be relevant, applicable or of specific safety interest for your machine.

If you are not sure and would like to view the original text or detailed explanations, click on the dropdown arrows for assistance.

22. Work through and carefully review the list​

Select all the suggested Annex I chapters you believe to be potentially relevant and applicable to your product.

💡 Take your time! Step by step.​

When in doubt read the explanatory text and include the section. You can always deselect it at a later stage if no longer required.

In addition, you can also manually search for further standards at any time later, so do not worry about perhaps missing something at this stage.

23. When you are finished click on next step​

Section 5 - Harmonized standards selection​

24. The suggested A and B harmonized standards listing​

CERTAIN has now prepared a rationalized shortlist of applicable harmonized standards based on your preselections, answers and understanding of your product's safety requirements.

💡 CERTAIN working smart not hard.​

Bear in mind, the list of over 900 harmonized standards out there is ever evolving and ever growing. During this process you have quickly filtered this down to this handful which are most likely to be relevant for your CE marking. This represents a significant saving in time and effort.

25. Standards selection​

You have reached the final section 5 of the guided legislation research.

Review the list of suggested harmonized standards and select the ones you intend to include. These chosen standards will be listed in your final declaration of conformity and full product documentation.

⚠️ Your chosen product standards!​

The harmonized standards you choose here are the standards that you have identified as being applicable to your machine. By declaring them in your documention your are confirming that you have taken them into consideration and have fulfilled their requirements during the design, production and quality control of your product.

26. Review the standards list​

Tick the harmonized standards you wish to include.

27. Save your product information​

💡 Save your valuable research!​

At this point it is very important to save your data. Although CERTAIN regularly saves your information in the background as you go, if you do unexpectedly close your browser or exit the application without consciously saving at this point you may have to repeat this entire process step.

You may of course edit or reselect your choices and answers at any time in the future by returning to the process step EU legislation and standards research from the product overview.

28. Return to the product overview​

On completing the standards research step you will see that the progress indicator has marked the legislation step as done.

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