CE Approval Guide for Manufacturers <18>
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
Personal protective equipment
Legislation
If your product(s) fall(s) within the sector of personal protective equipment, Regulation (EU) 2016/425 on personal protective equipment (PPE) applies.
- Regulation (EU) 2016/425 on personal protective equipment (PPE)
- Factsheet: CE marking for personal protective equipment (PPE)
- For further information on personal protective equipment, please also visit the the webpage dedicated to this subject: http://ec.europa.eu/growth/sectors/mechanical-engineering/personal-protective-equipment_en
Verify requirements
The New Approach legislation provides for the affixing of CE marking on products. If products are subject to several pieces of legislation, which all provide for the affixing of the CE marking, the marking indicates that the products are presumed to conform to the provisions of all the legislation covering their respected sectors.
The PPE Regulation (EU) 2016/425 specifies the essential health and safety requirements that the product needs to meet in order for the manufacturer to affix the CE marking.
The Regulation defines personal protective equipment (PPE) as:
(a) equipment designed and manufactured to be worn or held by a person for protection against one or more risks to that person's health or safety
(b) interchangeable components for equipment referred to in point (a) which are essential for its protective function
(c) connection systems for equipment referred to in point (a) that are not held or worn by a person, that are designed to connect that equipment to an external device or to a reliable anchorage point, that are not designed to be permanently fixed and that do not require fastening works before use.
The products must satisfy the essential health and safety requirements laid down in Annex II.
The Regulation defines in Annex I three risk categories of PPE. Category I consists of products designed to protect the user against minimal risks. Category III consists of products designed to protect the user against very serious risks. Category II includes PPE not listed in the above 2 categories.
This means that harmonisation is limited to essential health and safety requirements, while technical specifications to comply with such requirements are set out in voluntary harmonised European standards.
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 if you have to involve a Notified Body.
When dealing with personal protective equipment only category II and III require the involvement of a Notified Body.
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. If the Notified Body is involved in the production control phase (in case of category III PPE), its identification number will follow the CE marking.
For category II PPE, when the Notified Body verifies product’s compliance, it will issue an EU type-examination certificate to confirm this. In case of category III PPE additionally a production control is carried out. The manufacturer will then draw up the Declaration of Conformity (DoC) to declare on his sole responsibility the product’s conformity to the relevant legislation. The establishment of the DoC is a legal obligation.
The Declaration of Conformity must include the manufacturer’s details such as name and address, number of EC type-examination certificate (if applicable), any European standards and performance data and the identification number of the Notified Body as well as a legally binding signature on behalf of the organisation.
To find the Notified Bodies appointed by the Member States to carry out conformity assessment, please use 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
According to Article 19 of the PPE Regulation, for category I PPE, the manufacturer is required to follow the internal control procedure set out in Annex IV to establish the technical documentation and to draw up the EU Declaration of Conformity to confirm that his product complies with the health and safety requirements of the Regulation.
For category II PPE the Regulation specifies that the procedure set out in Annex V is to be followed, including an EU type-examination, which has to be carried out by a Notified Body. This must be followed by the conformity to type based on internal production control procedure set out in Annex VI.
Also for category III PPE, the Regulation requires that the procedure set out in Annex V is followed, including an EU type-examination, which has to be carried out by a Notified Body. After successful completion of the examination, the manufacturer must choose between either the conformity to type based on internal production control plus supervised product checks at random intervals procedure set out in Annex VII, or the conformity to type based on quality assurance of the production process procedure set out in Annex VIII.
In all categories of PPE the manufacturer has to draw up and sign the EU Declaration of Conformity.
Technical documentation
The PPE Regulation (EU) 2016/425 requires a technical documentation as laid out in Annex III. It must enable the assessment of the conformity of the PPE with the requirements of the Regulation. It must comprise all relevant data on the means used by the manufacturer to ensure that a PPE complies with the essential health and safety requirements relating to it.
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 substantially 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.
However, when one or more pieces of that legislation allows the manufacturer, during a transitional period, to choose which arrangements to apply, the ‘CE’ marking must indicate conformity with the legislation applied by the manufacturer only. In this case, the particularities of the legislation applied, as published in the Official Journal of the European Union, must be given in the documents, notices or instructions required by the legislation and accompanying such products.
If a Notified Body has been involved in the conformity assessment procedure, its identification number must also be displayed.
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