CE Approval Guide for Manufacturers <2>
Manufacturers play a crucial role in ensuring that products placed on the extended single market of the European Economic Area (EEA) are safe. They are responsible for checking that their products meet EU safety, health, and environmental protection requirements. It is the manufacturer’s responsibility to carry out the conformity assessment, set up the technical file, issue the EU declaration of conformity, and affix the CE marking to a product. Only then can this product be traded on the EEA market.
If you are a manufacturer, you have to follow these 6 steps to affix a CE marking to your product:
- Identify the applicable directive(s) and harmonised standards
- Verify product specific requirements
- Identify whether an independent conformity assessment (by a notified body) is necessary
- Test the product and check its conformity
- Draw up and keep available the required technical documentation
- Affix the CE marking and draw up the EU Declaration of Conformity (27 KB).
These 6 steps may differ by product as the conformity assessment procedure varies. Manufacturers must not affix CE marking to products that don’t fall under the scope of one of the directives providing for its affixing.
For products that present higher safety risks such as gas boilers, safety cannot be checked by the manufacturer alone. In these cases, an independent organisation, specifically a notified body appointed by national authorities, has to perform the safety check. The manufacturer may affix the CE marking to the product only once this has been done.
Product groups
Appliances burning gaseous fuels
Legislation
If your product(s) fall(s) within the sector of appliances burning gaseous fuels, Regulation (EU) 2016/426 on appliances burning gaseous fuels (GAR) may apply to it.
- Gas Appliances Regulation (EU) 2016/426 (GAR)
- Factsheet: CE marking for appliances burning gaseous fuels
- For further information on Regulation (EU) 2016/426 on appliances burning gaseous fuels (GAR), please visit the webpage on gas appliances regulation
Verify requirements
The New Approach legislation for CE marking has been designed by the European Union in such a manner that it covers all requirements for products from each of the aforementioned sectors.
Therefore, a product may be subject to more than one piece of New Approach legislation (and also to other harmonised legislation).
The GAR specifies in detail the essential requirements related to the use of gas as fuel the product has to meet in order for the manufacturer to affix the CE marking.
Regulation (EU) 2016/426 covers appliances burning gaseous fuels used for cooking, heating, hot water production, refrigeration, lighting or washing. It also covers fittings, defined as safety devices, controlling devices or regulating devices and sub-assemblies thereof designed to be incorporated into an appliance.
The basic requirements for placing appliances covered by the GAR on the European market, as laid out in Annex I of the GAR, demand the appliances to be so designed and constructed as to operate safely and present no dangers, they must be accompanied by technical instructions for the installer, instructions for use and servicing for the user, bear appropriate warning notices, which must also appear on the packaging. The instructions and safety information must be in a language which can be easily understood by consumers and other end-users, as determined by the Member State concerned.
The requirements also apply to fittings where the corresponding risk exists. Fittings intended to be part of an appliance must be designed and constructed in such a manner so that they fulfil their intended purpose correctly when incorporated in accordance with the instructions for incorporation.
Further details on the content and layout of the instructions as well as the essential requirements on design and construction can be found in Annex I of the Regulation (EU).
After downloading Regulation (EU) 2016/426 please study the paper carefully to ensure that your product can comply, at the time it will be placed on the market, with all the essential requirements of the Regulation. Please remember to also verify if other legislation applies to your product.
Need for notified body?
Before proceeding with the conformity assessment procedure, it is important to determine whether you, the manufacturer, can assess your product by yourself or whether you need to involve a Notified Body.
When dealing with the appliances and fittings covered by the Gas Appliances Regulation, the involvement of a Notified Body is obligatory.
A Notified Body verifies the compliance of a product by conducting a conformity assessment. It also ensures that the technical documentation sufficiently supports product compliance. In the framework of the GAR, a Notified Body is always involved also in the production control phase and its identification number will follow the CE marking.
When the Notified Body has assessed the compliance of the product-type and the type satisfies the applicable provisions, it issues an EU type-examination certificate to confirm this. Following completion of the production phase conformity assessment, the manufacturer will then draw up the Declaration of Conformity (DoC) to declare his sole responsibility that the product confirms to the relevant legislation. The establishment of the DoC is a legal obligation.
The Declaration of Conformity should include the manufacturer’s details such as name and address, essential characteristics the product complies with, any harmonised European standards and performance data and the identification number of the Notified Body as well as a legally binding signature.
To find the Notified Bodies appointed by the Member States to carry out conformity assessment, please refer to NANDO – the New Approach Notified and Designated Organisations database. You can search for Notified Bodies by legislation or by country via the NANDO homepage.
Check conformity
Article 14 of the Regulation sets out the process of certifying whether an appliance observes the requirements and can be placed on the market. For series-manufactured appliances and fittings, the process has 2 phases:
- First, the EU type-examination by a Notified Body, the details of which are explained in point 1 of Annex III to the Regulation.
- Second, under the surveillance of a Notified Body, the manufacturer must either complete one of three EU declarations of conformity to type procedures, or opt for the EU verification procedure. Details of these procedures are provided in points 2-5 of Annex III to the Regulation.
In cases where the appliance is produced as a single unit or in small quantities, the manufacturer can opt for EU verification by single unit, which is described in point 6 of Annex III.
Following completion of the production control conformity assessment, the manufacturer must draw up and sign the EU Declaration of Conformity.
Technical documentation
Regulation (EU) 2016/426 on appliances burning gaseous fuels requires that the application for type-examination must include, among other things, the technical documentation as described in Annex III.
The technical documentation must contain the following information, in so far as is required by the Notified Body for assessment:
- a general description of the appliance or the fitting
- conceptual designs and manufacturing drawings and schemes of components, sub-assemblies, circuits, etc.
- descriptions and explanations necessary for the understanding of those drawings and schemes and the operation of the appliance or the fitting
- a list of the harmonised standards applied in full or in part, the references of which have been published in the Official Journal of the European Union and, where those harmonised standards have not been applied, descriptions of the solutions adopted to meet the essential requirements of this Regulation, including a list of other relevant technical specifications applied. In the event of partly-applied harmonised standards, the technical documentation shall specify the parts which have been applied
- test reports
- instructions for installation and use of the appliance
- the EU declaration of conformity of the fitting containing the instructions on how the fitting should be incorporated into an appliance or assembled to constitute an appliance
The manufacturer or his authorised representative established in the European Union is requested to keep copies of the technical documentation for a period of 10 years after the last product has been placed on the market.
Affix CE marking
Once the necessary steps have been successfully completed, the CE marking must be affixed to the product.
The marking must be placed visibly and legibly on the product or, if not possible due to the nature of the product, be affixed to the packaging and the accompanying document. The CE marking shall consist of the initials 'CE' taking the following form:
The various components of the CE marking must have the same vertical dimension, and may not be smaller than 5 mm. If the CE marking is reduced or enlarged, the proportions given in the graduated drawing above must be respected.
When the product is subject to other legislation covering other aspects and which also provide for the ‘CE’ marking, the accompanying documents must indicate that the product also conforms to that other legislation.
The identification number of the Notified Body involved in the production control phase must follow the CE marking.
△ The above picture and text are from the Internet. If there is any infringement, please contact us in time and we will delete it immediately.
As the first global market access digital platform, BWTCmall.com offers a new and unprecedented online service experience for its many users.
As a technology-driven company, BWTCmall.com is committed to developing a powerful and scalable platform that not only enables global manufacturers to quickly and accurately find the best way to reach the global market, but also to experience cost-effective cutting-edge technology and services. Let the global market access market truly enter a virtuous circle of fairness, objectivity, harmony and win-win.
Please visit the solution for get your best way of testing and certification / approvals to the target market.
