FREQUENTLY ASKED QUESTIONS
- 13 February, 2018
- Posted by: marcacaoce.eu
FAQ Frequently asked questions
See the most frequently asked questions about CE marking here. If your doubt is not clarified do not hesitate to contact us and one of our specialists will contact you for any clarification you need.
1 What is CE Marking
CE marking is the evidence given by the manufacturer that your products are in compliance with the requirements set out in EU directives (commonly referred to as “New Approach Directives”) applicable to them.
Affixing the CE marking on a product allows its free movement within the European Economic Area (EEA)
The conformity assessment procedures of the products with the directive standards aim to ensure that the products placed on the market comply with the requirements expressed in the policies, in particular concerning the health and safety of users and consumers. Such compliance applies not only to the essential obligations, but also to the specific obligations laid down in the directives.
The conformity assessment is based on:
- Activities developed by the manufacturer under the factory production control, including product design and development, where applicable
- The activities carried out by third parties (typically a notified body), which may include, among others, initial type tests and approval of quality assurance or production system, in conjunction with the activities of the manufacturer in the factory production control
The CE marking must be affixed by the manufacturer or his authorised representative established within the Community and, exceptionally and with proper justification, by the person responsible for placing the product in the EU market.
2 What products require CE Marking?
CE marking is applicable to all products covered by at least one of the New Approach Directives.
Therefore, you must check if the product to be placed on the EEA market is within one of the directives that require CE marking. Below is the list of product categories by CE marking:
- Gas appliances
- Equipment and protective systems intended for use in potentially explosive atmospheres
- Pyrotechnic articles
- Hot-water boilers fired with liquid or gaseous fuels
- Electromagnetic compatibility
- Active implantable medical devices
- Medical devices
- Medical devices: in vitro diagnosis
- Ecodesign and energy labelling
- Recreational craft
- Noise emissions
- Low-voltage electrical equipment
- Personal Protective Equipment – PPE
- Radio communication and telecommunication terminal equipment
- Pressure equipment
- Explosives for civil use
- Cableway installations designed to carry persons
- Measuring instruments
- Non-automatic weighing instruments
- Construction products
- Simple pressure vessels
- Safety of machinery
- Safety of toys
Products that do not require CE marking include:
See also “WHICH DIRECTIVES AND REGULATIONS ARE APPLICABLE TO PRODUCT CE MARKING?”
NOTE: Depending on the complexity of the products, official positions and clarifications are often published by competent authorities on the framework of a given product or family of products, for example, which are the metallic structures/components subject to CE marking under the construction products regulation. (Reg. EU 305/2011) in accordance with standard EN 1090-1.
3 What are the obligations of the economic operators?
The responsibilities within the CE Marking are dependent on the role played by the economic operator.
The following table briefly presents the different responsibilities of economic operators:
4 How do I obtain the CE marking for my product?
5 In which countries is CE Marking mandatory?
CE marking is a requirement for products placed on the European Economic Area (EEA) market, regardless of where they are manufactured. The EEA consists of the European Union (EU) Member States on the one hand, and by three of the four countries of the European Free Trade Association (EFTA) on the other – Liechtenstein, Iceland and Norway (called EEA-EFTA countries).
6 Which directives/regulations demand CE Marking?
The list of product categories covered by the CE marking are the following:
- Gas appliances | Directive 2009/142/CE
- Equipment and protective systems intended for use in potentially explosive atmospheres | Directive 2014/34/UE
- Pyrotechnic articles | Directive 2013/29/UE
- Lifts | Directive 2014/33/UE
- Hot-water boilers fired with liquid or gaseous fuels | Directive 92/42/CEE
- Electromagnetic compatibility | Directive 2014/30/EU
- Active implantable medical devices | Directive 90/385/CEE
- Medical devices | Directive 93/42/CE
- Medical devices: in vitro diagnosis| Directive 98/79/CE
- Ecodesign and energy labelling | Directive 2009/125/CE
- Recreational craft | Directive 2013/53/UE
- Noise emissions | Directive 2000/14/CE
- Low-voltage electrical equipment | Directive 2014/35/UE
- Personal protective equipment – PPE | Directive 89/686/CE
- Radio communication and telecommunication terminal equipment | Directive 2014/53/UE
- Pressure equipment | Directive 2014/68/UE
- Explosives for civil use | Directive 2014/28/UE
- Cableway installations designed to carry persons | Directive 2000/9/CE
- Measuring instruments | Directive 2014/32/EU
- Non-automatic weighing instruments | Directive 2014/31/UE
- Construction products | Regulation CE 305/2011
- Simple pressure vessels |Directive 2014/29/CE
- Restriction of the use of certain hazardous substances in electrical and electronic equipment | Directive 2011/65/EU
- Safety of machinery | Directive 2006/42/CE
- Safety of toys | Directive 2009/48/CE
7 Which are the product conformity assessment procedure available?
Conformity assessment schemes are represented in the following figure:
8 What is the declaration of conformity?
The EU Declaration of conformity is a document that certifies that the product meets the essential requirements of the applicable legislation.
When preparing and signing the EU Declaration of conformity, the manufacturer (or his authorised representative established in the EU), takes responsibility for the conformity of the product.
The EU Declaration of conformity must be issued prior to the placing of the product on the market.
Under the regulation of construction products (Reg. EC 305/2011), the declaration of conformity is called declaration of performance. On the other hand, under Directive 2006/42/EC on machinery, this provides that the placing on the market of “partly completed machinery” is accompanied by a declaration of incorporation, which is different from the EU Declaration of conformity.
The criteria for the Declaration of conformity can be found in annex III to Decision No. 768/2008/EC. On the other hand, the criteria associated with the Declaration of performance are defined in Council Regulation EU No. 574/2014.
For more detailed information and templates of the documents, please click here.
9 What are the documentation / Thecnical file requirements?
The manufacturer must draw up the technical documentation in conformity with the particular requirements set by the Directives/Regulations applicable to your product. The content of the technical documentation is, therefore, established in each act of harmonisation of the Union, in accordance with the products concerned. As a general rule, documentation must include records/information on:
- The description of the product and its intended use
- How the product is manufactured
- How the compliance of the product is demonstrated, with regards to the relevant standards applicable
- The address of the manufacturer and possible storage locations
- Design and manufacture of the products
- Which Directives apply to the product and evidence of compliance with their requirements
- Certificates of the type examinations performed, if applicable
The elements included in the documentation depend on the nature of the product and what is considered necessary, from a technical point of view, to demonstrate the compliance of the product with the essential requirements of the relevant Union harmonisation legislation or with harmonised standards, if these have been applied, indicating the essential requirements covered by the standards.
This documentation may also be part of the quality system documentation, if the legislation provides for a conformity assessment procedure based on a quality system (modules D, E, H and their variants).
For some Directives/regulations, the technical documentation must be drafted in the language of the Member State where the product conformity assessment will be carried out, or in a language accepted by the notified body.
10 What are the consequences of not having Ce Marking on my product?
Affixing of the CE marking on a product certifies that its manufacturer, or authorised representative in the EU, submitted the product to the appropriate conformity assessment scheme in order to ensure its compliance with the essential requirements legally defined. Consequently, it allows the access of the product to the European market.
In order to ensure the enforcement of legislation related to CE marking and ensure the safety of products, each EU Member State designates the entities responsible for enforcing such legal requirements. The entities responsible for market surveillance and the methods used vary according to the Directives that are applicable to your product. Generically, these entities may supervise the market, evaluate whether a particular product complies with the applicable requirements, and take action when non-conformities are identified. These measures may include the seizure of the product, withdrawal from the market, as well as fines.
11 How can I highlight my product's CE Marking?
CE marking must be affixed in a visible, legible and indelible form on the product, or on its nameplate. However, if this is not possible or advisable due to the nature of the product, the CE marking shall be affixed to the packaging, if any, and/or on the documents accompanying the product.
When additional requirements are not defined in the Directives, the minimum height required is 5 mm.
The CE marking may take different forms (for example, color, solid/hollow look), provided it continues to be visible, legible and meets the proportions. The CE marking must also be indelible, so that it cannot be removed under normal circumstances without leaving visible traces.
When a notified body is involved in the production control phase, its identification number must follow the CE marking.
12 What are notified bodies and what is their role?
A Notified Body (NB) is an independent body that carries out one or more of the conformity assessment activities under the European Directives/Regulations regarding CE marking.
Member States are responsible for notifying the Notified Bodies, based on the evidence of their competence to carry out the tasks laid down in each Directive or Regulation. The competency assessment is usually performed by the National Accreditation Body, taking into account the decision of the Commission.
13 I distribute products with CE Marking. What are my responsabilities?
A distributor is any individual or collective in the commercial circuit, in addition to the manufacturer or importer, who provides a product on the market.
Retailers, wholesalers and other distributors of the marketing chain do not require a preferential relationship with the manufacturer, unlike the representative. A distributor buys products from a manufacturer, importer or another distributor for further distribution.
Before having a product available on the market, the distributor should check the following formal requirements:
- that the product bears the required marking(s) (e.g. CE marking),
- that the product includes the relevant documents (e.g., the EU Declaration of conformity) and the instructions and safety information in a language which can be easily understood by consumers and other end-users, if required by applicable legislation,
- that the manufacturer and the importer have indicated
- their name,
- registered trade name or registered trade mark and
- the address at which they can be contacted on the product or, if the size or the physical characteristics of the product does not allow it, on its packaging and/or accompanying documentation, and that the product includes an indication of the type, batch or serial number, or any other elements that allow its identification.
Importers or distributors are considered manufacturers, and are subject to the same duties as them, whenever they place on the market a product in their name or under their brand, or change a product already placed on the market in such a way that the compliance with the applicable requirements may be affected.
14 I import products with CE Marking. What are my responsabilities?
The importer is an individual or collective established in the Union to place a product from a third country on the EU market. Their responsibilities are similar to the kind of responsibilities that a manufacturer established in the EU is subject to.
As a general rule, before placing a product on the market, the importer must ensure that:
- That the manufacturer has applied the appropriate conformity assessment procedure. If there are any doubts concerning the product’s compliance, it should refrain from putting it on the market. If the product has already been placed on the market, they must take corrective measures. In both cases, the manufacturer may need to be contacted to clarify any doubts as to the conformity of the product;
- That the manufacturer has drawn up the technical documentation, after the relevant conformity marking (e.g. CE marking), has fulfilled its obligations regarding traceability and has included in the product, in relevant cases, the instructions and safety information in a language easily understood by consumers and other end-users, as determined by the Member State concerned.
The importer must also:
- Indicate the following elements:
- their name;
- the registered trade name or brand and
- the address at which they can be contacted on the product or, if the size or physical characteristics of the product does not allow it, or the packaging has to be opened, on the packaging and/or on the documentation accompanying the product. However, it must not affect the visibility of any safety information printed on the product or on the accompanying documents
- ensure that, while a product is under your responsibility, storage or transport conditions do not affect the compliance of the product with the requirements laid down in the applicable legislation,
- keep a copy of the EU Declaration of conformity for 10 years from the date of placing the product on the market, or for the period specified in the relevant Union harmonisation act,
- ensure that the technical documentation can be made available to the competent national authority, if requested. The importer shall cooperate with that authority and, upon reasoned request, provide all the information and documentation required in a language easily understood by that authority, to demonstrate the compliance of the product. The idea is that the national authority can accept a language that they understand and that is different from the national language(s). The language chosen is subject of negotiation with the authority and can be a third language, provided it is accepted by the authority.
- In the case of a reasoned request, it is sufficient for the importer to provide the technical documentation elements related to the alleged non-conformity, demonstrating that the question was addressed by the manufacturer. Therefore, any request for translation of the technical documentation shall be limited to those documentation elements.