European Union is currently a political and economic organization consisting of 28 member states with a total population of more than 500 million. One of the four basic freedoms granted by this union is the free movement of goods.
CE Marking signifies that the products meet all the requirements of the EU technical regulations and can be circulated among the member states of the EU without facing any technical barriers.
The general rules regarding the free movement of products are explaining in the “COMMISSION NOTICE The ‘Blue Guide’ on the implementation of EU products rules 2016”.
What is CE Certificate?
We see capital letters CE on many products in free movement in the European Economic Area. This marking, meaning Conformity with Europe, demonstrate that the products have been audited/assessed in terms of minimum safety, health and environmental requirements. You would see CE marking on a new telephone, food processor, TV set or crayons purchased in the European Community. CE marking also indicates fair competition among manufacturers as it enforces accountability and conformity with the same requirements.
A manufacturer who affixes CE marking to his products, declares that the products are in conformity with all necessary requirements (regulations and standards) and can be sold in the economic area. CE Certificate secures two great advantages for the business world and consumers. The business world acknowledges that products bearing CE marking can be sold in the European Economic Area without facing any barriers, and consumers feel assured that products they purchase meet all essential health, safety and environmental requirements.
It is the manufacturer’s responsibility to carry out conformity assessment of products, to prepare technical files, to acquire CE marking where necessary, to draw up EU Declaration of Conformity, and to affix CE marking to the products.
How to get CE Certificate?
All conformity assessment procedures (modules) including testing, inspection and/or CE certification must be completed before the product is placed on the market. Manufacturers should confirm the regulations covering their products, and if necessary, should apply to notified bodies designated to give conformity assessment services.
The EU Declaration of Conformity should contain the following information related to the product, manufacturer or representative, notified body where applicable, and harmonised standards:
- Unique identification of product,
- Name and address of manufacturer or authorised representative,
- Statement of sole responsibility of the manufacturer of this declaration,
- Identification of product allowing traceability, clear product photograph where appropriate,
- Relevant European Community directive,
- References to the relevant harmonised standards and/or specifications,
- Where applicable, the name and ID number of the notified body, description of the module and CE certificate information,
- Additional information, signature, name and function of designated signatory, and place and date of issue.
How to affix CE marking to products?
The “CE” mark consists of the letters “CE” in accordance with the figure and ratio below. CE marking shall be affix visibly, legibly and indelibly on the product information plate / label. If these conditions cannot be met due to the nature of the product, it shall be affix to the product package or to the appropriate documents. In cases where it is required to be reduced or enlarged, the proportions in the figure below are followed. Unless otherwise specified in the relevant technical regulation, the “CE” mark shall be at least 5 mm in size.
The essential property of the EU legislation is to ensure high level of health and safety limits of products bearing CE marking. The essential requirements apply to the hazard inherent to a product. That is why, if not laid out in the harmonised standards, manufacturers must perform risk analysis and include the results in their technical files.
While essential requirements indicate the results to be achieved and the hazards to be eliminated, they do not give a clue on technical solutions or how to eliminate these hazards. Manufacturers can reach real solutions and application details using the related harmonized standards or specifications.
What should a technical file (technical documentation) include?
EU harmonization legislation imposes on the manufacturers the obligation of preparing a technical file containing information that proves the conformity of their products to the essential requirements and to keep this file for 10 years. The technical file which is under the manufacturer’s or the authorised representative’s responsibility can be a part of the quality system documentation in the quality-system based conformity assessment procedures.
Though the information to be included in the technical file is detailed in every regulation, it is generally the information and documents on the definition, purpose of usage, design, production and operation of the product. You can find detailed information on our website.
CE certificate and conformity assessment modules
Conformity assessment modules cover both the design and production phases. While some cover only one phase, others can do both. Conformity assessment modules consist of 8 main categories:
- Module A, A1, A2 – Internal production control
- Module B – EU-type examination
- Module C, C1, C2 – Conformity to EU-type based on internal production control
- Module D, D1 – Conformity to EU-type based on quality assurance of the production process
- Module E, E1 – Conformity to EU-type based on product quality assurance
- Module F, F1 – Conformity to EU-type based on product verification
- Module G – Conformity based on unit verification
- Module H, H1 – Conformity based on full quality assurance
Notified bodies perform calibration, testing, auditing, inspection and certification activities indicated in the conformity assessment procedures when a third party attestation is required. Notified bodies are designated by notified authorities (related ministries) in terms of the applicable directives, and communicated to the EC.
Notified bodies can deliver conformity assessment services within the EU or in third countries. They must provide information to the notification authority and to market surveillance authorities and carry out their activities impartially, independently, indiscriminatingly and competently. They should have accreditation as proof of their competence.
Why is accreditation preferable?
Accreditation is the attestation of the national accreditation body (TURKAK) of a conformity assessment body to have the technical competence to carry out the related conformity assessment activities as stated in the harmonised standards. The legal framework of the accreditation requirement in EU has been drawn by Regulation 765/2008. Accreditation is very important in ensuring product conformity through well working and trustworthy conformity assessment activities.
SZUTEST has been accredited by TURKAK on the following standards within the scope of EC 765/2008 and 2008/68/EC:
- TS EN ISO/IEC 17020 Conformity assessment — Requirements for the operation of various types of bodies performing inspection
- TS EN ISO/IEC 17021-1 Conformity assessment – Requirements for bodies providing audit and certification of management systems
- TS EN ISO/IEC 17024 Conformity assessment – General requirements for bodies operating on certification of persons
- TS EN ISO/IEC 17025 General requirements for the competence of testing and calibration laboratories
- TS EN ISO/IEC 17065 Conformity assessment – Requirements for bodies certifying products, processes and services
Frequently Asked Questions FAQs
CE is a label derived from the initials of the words; ’European Conformity’. The requirements of the mark of CE comes from the standing orders from a forum in France which was called ‘Conformite European’. The initial letters in French created the letters of the mark. “CE” is easier to read and thus rising its popularity.
We need to remind you that the “CE label’’ usage is more accurate than the “CE Certificate”. Because what really matters is the CE mark itself not the CE certificate. We need to mention that the documents that are called CE Certificate are named differently in the different standing orders. We can say that; the concept that is known as the CE certificate is actually “A legal document that gives a company the right to attach CE mark on its products.”
If we need to give some examples of different names given for CE Certificate, one would be “EC Type Examination Certificate” in the machine security standing orders, “Certificate of Conformity of Factory Production Control” as in the construction products’ standing orders.
Due to validated institutions’ accreditation rules the predefinition of certification process cannot be made accurately. On the other hand, the process can vary from one to another depending on the features of the product, area of usage and the requirements extended in the regulations.
To shorten the process, the responsibility of the producers is to have a thorough knowledge of their product’s requirements. In addition to this, applying the quality management systems shortens the certification process.
If you want to get a more accurate reply for this question, you can contact the expert staff of Szutest and get more detailed information about the product’s certification process.
As mentioned above, CE Certificate can be identified as “A legal document that gives the right to attach CE mark.”
The producer must obey the legal necessities when he wants to present his products in the European Union and Turkey.
The application process of CE marking is not in voluntary basis, it is an obligation if it is in the scope of the regulations. If the product is not in the extent of any standing orders, it may not be possible to use the CE mark.
It states that the products meet the criteria of basic security, environment and health that are determined by European Union.
The products cannot be put on the European Union and Turkish market unless they have the CE label. For instance, a vehicle can’t be at the traffic without any license, it is the same with the product sales.
If the products are supplied to the market without CE mark and detected by the authorities, the relevant ministry would apply administrative sanctions like reclaiming of the products or suspension of the de factory production.
It is deceptive that the obligatory on CE label during the product deliveries in the customs procedure is just for the countries that are in the European Union. Because the ministries within our country observe the industry and can detect the products that are in the CE label extent.
That is why the suppliers need to get the certificates before they supply their products to the market to avoid these kind of situations.
We have mentioned that a CE label is valid in Turkey and the countries that are member of European Union.
We also need to mention that the credibility and awareness of the CE label rises globally as it stands for trust. Even though there is no legal statute it is approved by lots of countries in Asia, Middle East and Far East.
Even different certificates are needed at the countries outside the Europe Economic Area due to their legal statutes, the customers could prefer the products with a CE mark while choosing a supplier.
You need to get your CE certificate from a certification body with an “Notified Body” status as SZUTEST. Approximately 1000 approved institutions in the European Union borders perform CE label certification process.
If the responsibility of certification is given to a notified body of CE mark term in the regulations, certificates which are taken from other institutions without “Notified Body” status would be invalid.
Our sectoral experience coming from our customers, shows us that this kind of situations are what our producers most suffer from. However, the documents that are taken from the non-approved institutions will not cause any legal actions, they would be invalid. In this sense, since it is the producer’s responsibility, you need to be sure that the institution which will publish the document has proper authorizations.
A Notified Body has a 4-digit identity number which is different from an ordinary licensing institution. You can check out the data base of the European Union’s official media organ called ‘NANDO’ to see whether an institution has an authority in the given regulations.
It is indicated in the Official Journal numbered 28213, the regulations about the attachment of CE brand to the product in the CE Mark Regulations. Moreover, in the directive which the product is extended, the details are mentioned about how CE marking should be done.
As an example, you need to refer to the regulations for the issues on using an Notified Body’s identity number with CE mark. Yet, a definition like this wouldn’t be wrong. CE brand should be;
- Attached on the product
- Attached on the label of the product
- Attached on the product’s package and box
If those are not possible then it can be used with some official documents as product’s dispatch note or bill…etc.
You only need to apply for CE mark if your product will be sold in European Union and Turkey. At the same time the products need to be liable to the scope of one of the 32 regulations.
In general, we can say that every product which can cause risk for human health and environment, needs a CE mark. What is more, the regulations that we mentioned before should be examined in detail.
If you want to learn whether your product is in the extent of any standing order or not, you can reach us via all platforms.
Although it is imposible to create a summary of all the regulations, As SZUTEST and with our collaborations, we are able to serve our customers for certification activities in the following scopes. Within the scopes marked with (*), SZUTEST continues its activities as a Notified Body No 2195.
- Medical Devices*,
- Machinery * and Electrical Equipments,
- Lifts and Safety Components for Lifts*
- Personal Protective Equipment*
- Construction Products*
- Equipment and Protective Systems Intended for Use in Potentially Explosive Atmospheres*
- Simple Pressure Vessels*
- Pressure Equipment*
- Appliances Burning Gaseous Fuels *
- Hot-water Boilers Fired With Liquid Or Gaseous Fuels *
- Equipment Used in Railways,
- Noise emission in the environment by equipment for use outdoors
WE GIVE CE CERTIFICATION SERVICE FOR THE FOLLOWING EU/EC DIRECTIVES
The EU/EC Directives for which SZUTEST gives testing, auditing, inspection and certification services as Notified Body No. 2195 are as following:
The EU/EC Directives for which SZUTEST may give testing, auditing, inspection and certification services through its partners are as following;