The European New Approach Directives form the starting point of the CE marking (Conformité Européenne). In these directives manuals are also discussed extensively. What do the European New Approach Directives mean and what do they mean for you and the manuals of your products?
What Are the New Approach Directives?
The directives give essential requirements regarding to health, security, the environment and consumer protection for products which are traded within the European Economic Area (EEA). The directives form the starting point of the CE marking. The above named essential requirements apply to different products. For example, there are directives for machines and medical devices, but also for pressure vessels and toys.
How do these directives come into being? First the European Commission, the Advisory Commission or the business marshal will form a proposed-directive. Then The European Council of Ministers determines whether the directive is adopted or not. If the directive is adopted, member states are obliged to receive the requirements linked to the directive in their national legislation. This should happen within a certain period of time, which usually takes two years. The period until the admission of the directive is generally called ‘transitional phase’. After that, the directive is binding and in principle there can’t be made any heavier or more additional requirements by the member states. Often this results in existing laws which need to be changed to avoid contradictions or duplicates.
To describe how the requirements of the directives can be realized technically, standards are being developed on European level. When a manufacturer applies the (harmonized) standards, which moreover is not mandatory, this results among other things in the following advantages:
- s/he makes use of the latest technology in the field of safety;
- s/he makes directives concrete;
- s/he realizes a ‘presumption of conformity’ with the fundamental requirements of the directives
- s/he builds up a maximum legal burden of proof;
Who Applies the CE Mark?
The responsibility for the compliance of the directives is situated by the person who brings the products within the limits of the EEA on the market.
These could be:
- the manufacturer: if the manufacturer is located within the EEA, s/he is then responsible for the CE mark at all times. When the manufacturer is established outside of the EEA, the responsibility is mostly the matter of the importer or the ‘In the Community Established Plenipotentiary’;
- the ‘In the Community Established Plenipotentiary’: s/he is appointed by the manufacturer and takes over certain tasks. An example of such a task is the signing of the EC-declaration of conformity or the applying of the name and address on the identification plate. In these cases, the importer is authorized as if s/he is the manufacturer;
- the importer of products from outside the EEA: s/he is entirely responsible for the placing of the CE marking, even though that s/he is not authorized by the manufacturer.
The responsibility for the CE marking lies only at the trading company when it is regarded as a manufacturer. This is the case if the trading company:
- assembles the product itself;
- modifies or expands the product whereby the safety level changes;
- sells the product under his own name (private label). The new seller of course must apply the required data on the product, needs to draw their own EC declaration of conformity and needs to change the personal data in the user manual. The initial concept is the data of the supplier;
- imports the product from a non-EEA country
On the base of the Product Liability Law you can be held responsible for your product. When the product is purchased from a manufacturer within the EEA, in the most cases the Liability Promise (and/or claim) can be shoved up to the manufacturer. But when the product is purchased outside of the EEA, then you are directly responsible as the ‘In the Community Established Plenipotentiary’.
Action Plan for the Manufacturer
The manufacturer needs to perform several actions in order to meet the requirements for the CE marking. These various actions are clearly listed below:
Steps towards CE marking
- Define your product (determine the most important risks and describe the meant use);
- Determine which directives are of use (check if your product falls between the field of application of the directives);
- Test the product on the essential requirements and bring the product in line with these (risk analysis, safety measures based on the European standards, test reports etc.);
- Perform the right certification procedure (if necessary, engage a notified body);
- Determine which European standards are applicable (study the standards and apply them);
- Verify that the purchased product components are provided with the proper documentation and declarations;
- Verify that the procurement contracts are complete and are equipped with agreements about the CE marking;
- Verify that the delivery note is provided with adequate information regarding the CE marking;
- Develop a user manual and translate it to the proper language;
- Put together a fully Technical (Construction) File and archive it;
- Draw up an EC Declaration of Conformity and sign it;
- Apply the CE marking;
Action Plan for the Trading Company (and the place of the user manual)**
Even if a trading company is not regarded as a manufacturer, it still has its certain responsibilities in the field of the CE marking. The action plan below puts these in a row:
Steps towards CE marking
- Define your product (determine the most important risks and describe the meant use);
- Determine which directives are of use (make sure that your product falls within the field of application of the directive);
- Verify that the purchase agreements are complete and provided of the agreements of the CE marking;
- Check if the user manual is provided. Translate the manual if needed into the proper language;
- Check whether the EC Declaration of Conformity is available;
- Verify that the CE marking is applied.
Fundamental Requirements of the Directives
The fundamental requirements are generally related to the technical safety aspects of the product itself. These are the ‘in practice’ requirements which you are most concerned with. You can find these requirements in Annex 1 of every New Approach Directive.
Government Inspectors will first check if the products meet these fundamental requirements during inspections. The fundamental requirements also include requirements regarding documentation and marking (user manual, installation instructions, maintenance prescriptions, EC declaration, CE marking). These requirements form the starting point for European standards. For example, the directives require adequate instructions for use. The European harmonized standard EN 82079–1 gives minimal requirements for instructions for use.
In most cases, the manufacturer or trader can certificate themselves. This ‘self-certification’ is usually also referred to as internal manufacturing inspection. If it regards products with an increased risk, an inspection agency (notified body) must be engaged.
If you assemble the product yourself, then it is very likely that you buy a large number of parts. In some cases, the supplier has to provide the parts with an affixed CE marking. But even if that is not the case, the parts must still comply with the CE requirements set by you, so that the final product can meet the essential CE requirements. For this reason, it is recommended to register the agreements about the CE marking, including the task division, in a repurchase agreement. Examples of what you can register in such an agreement:
- That the manufacturer puts together the Technical (Construction) Dossier and stores it.
- What directives the product or the component must comply.
- Whether it is necessary to engage an inspection agency for the certification procedure.
- What standards the product or component will meet (not mandatory)
Many products should include a manual to explain how to use the product safely. Mostly, the manual includes instructions for laypeople and service- maintenance instructions for specialized users. For consumer products, only a user manual is enough.
All potential dangers that come with the use of the product should be described in the manual sufficiently. Also, the possible dangers caused by improper use should be taken into account. Only when the manufacturer pays attention to the requirements, (professional) knowledge and the experience of the user, warnings can be properly formulated. A manual should therefore always be written for that user.
Possible structure of a user manual:
- Title page, product name, type or code, trade name, image;
- Technical specifications and certification (Declaration of Conformity);
- Relation to other documents;
- Contents, list of images, icons and attachments;
- Introduction: indications for the use of the user manual;
- General safety prescriptions;
- Description of the product, composition of the product;
- Implementation, installation, adjustments;
- Description of the operation, how to use the product, application possibilities;
- Maintenance and maintenance schedule;
- Storage and transport;
- Faults and repairing;
- Accessories, and peripherals;
- Dismantle, environment;
According to most directives, the manual must be translated into the language of the country where the product is being used. The person that imports the product in a specific language area is responsible for the correct translation. This also applies for a trading company that sells a product to another language area. For a manufacturer it is difficult to foresee to which countries his products are finally exported by trading companies or third parties.
Technical (Construction) File
The Technical (Construction) File defines the product design and the conditions for safe usage. The file contains information such as drawings, certificates, test reports, calculations, the user manual, part lists etc. The Technical File is kept by the manufacturer, which keeps it available for competent national authorities. The physical presence of the dossier is not always necessary, but it must be available within a few weeks. In principle, the documents must be retained until 10 years after the manufacturing date of the product or after the last unit was produced (when the product is made in series). In some directives the Technical File forms a key feature in the conformity assessment.
EC Declaration of Conformity
For each product or series of the same product that falls under a European New Approach Directive, an EC Declaration of Conformity should be prepared. This declaration indicates that the product complies with the requirements of the directive(s). When it comes to various directives, the compliance can be represented within one EC declaration. It is however necessary to mention the data of the notified body that performed the EC type-examination or the quality system evaluation. The declaration is signed by an authorized person of the company, who uses the same language as used in the user manual. The EC declaration of conformity must, in some cases, be sent together with the product. In the Technical (Construction) Dossier a copy is enclosed. In other cases it is sufficient to preserve the declaration yourself, depending on the directive that applies to the product.
Applying of the CE Marking
The CE marking is only applied when the product meets all relevant European New Approach Directives. This is usually done on the identification plate, on a label or with a sticker. Some directives allow that the CE marking is not applied on the product itself but on the packaging.
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