How Do You Get a CE Mark

What is CE Mark?

CE marking is a conformity mark within the single market of the European Union, indicating that a product meets the essential safety, health, environmental and performance requirements stipulated by the relevant EU harmonization regulations. By affixing the CE mark to the product, the manufacturer declares that the product complies with the legal requirements for CE marking. For more information, please refer to the EU CE Marking.

Scope of Application of CE Mark

Not all goods sold in the European Economic Area need to bear the CE mark. Common goods that require the CE mark include, but are not limited to, batteries, toys, electronic products, personal protective equipment, machinery, gas appliances, pressure equipment and measuring devices, etc. To find out whether your goods fall within the scope of CE marking, please refer to the product categories covered by the following EU harmonization legislation:

①　Toy Safety – Directive 2009/48/EU

②　Transportable Pressure Equipment – Directive 2010/35/EU

③　Restriction of Hazardous Substances in Electrical and Electronic Equipment – Directive 2011/65/EU

④　Construction Products – Regulation (EU) No 305/2011

⑤　Pyrotechnic Articles – Directive 2013/29/EU

⑥　Recreational Craft and Personal Watercraft – Directive 2013/53/EU

⑦　Civil Explosives – Directive 2014/28/EU

⑧　Simple Pressure Vessels – Directive 2014/29/EU

⑨　Electromagnetic Compatibility – Directive 2014/30/EU

⑩　Non-automatic Weighing Instruments – Directive 2014/31/EU

⑪　Measuring Instruments – Directive 2014/32/EU

⑫　Lifts – Directive 2014/33/EU

⑬　ATEX – Directive 2014/34/EU

⑭　Radio Equipment – Directive 2014/53/EU

⑮　Low Voltage – Directive 2014/35/EU

⑯　Pressure Equipment – Directive 2014/68/EU

⑰　Marine Equipment – Directive 2014/90/EU

⑱　Cableway Installations – Regulation (EU) 2016/424

⑲　Personal Protective Equipment – Regulation (EU) 2016/425

⑳　Gas Appliances – Regulation (EU) 2016/426

21　Medical Devices – Regulation (EU) 2017/745

22　In Vitro Diagnostic Medical Devices – Regulation (EU) 2017/746

23　EU Fertilising Products – Regulation (EU) 2019/1009

24　Drones – Regulation (EU) 2019/945

25　Batteries – Regulation (EU) 2023/1542

26　Machinery – Regulation (EU) 2023/1230 (replaces Directive 2006/42/EC which was in force before the New Legislative Framework (NLF) and remains applicable until 20 January 2027)

27　Ecodesign Requirements for Sustainable Products – Regulation (EU) 2024/1781

28　Artificial Intelligence Act – Regulation (EU) 2024/1689

29　Cyber Resilience Act – Regulation (EU) 2024/2847

Note: Not all products must bear the CE mark. Only most products covered by the New Approach Directives are required to bear the CE mark. Other products are prohibited from bearing the CE mark.

How to Display and Use the CE Mark?

1. Prerequisite for Use: Completion of Conformity Assessment Procedures

The CE mark shall not be used arbitrarily; it may only be used after the product has completed the conformity assessment procedures required by the applicable EU harmonization regulations. Such procedures include, but are not limited to:

①　Self-assessment or testing by a third-party notified body (according to product category requirements);

②　Preparation of technical documentation;

③　Signing the Declaration of Conformity (DoC);

④　Other procedures stipulated by applicable regulations.

2. Display Requirements: Size, Location and Format

The appearance and display of the CE mark are strictly regulated:

①　Location: Shall be affixed to the product itself or its nameplate. If affixing is not possible due to size or characteristics, it may be displayed on the product packaging or accompanying documents;

②　Visibility and Indelibility: The CE mark must be clearly visible, easily recognizable and indelible;

③　Size: Unless otherwise specified by specific regulations, the height shall be no less than 5 mm;

④　Proportion: The proportion standards specified in Annex II must be followed when scaling;

⑤　Format: The unified EU format must be adopted.

❗ Note: No other markings or graphics that may cause misunderstanding of the meaning of the CE mark shall be affixed to the product.

3. Special Products: Notified Body Identification Number to be Displayed Next to the CE Mark

①　If a notified body is involved in the conformity assessment procedure, its identification number shall be displayed next to the CE mark. Applicable products include, but are not limited to:

②　Category III Personal Protective Equipment (PPE)

③　Class I and Class II Medical Devices

④　Other products requiring notified body involvement in conformity assessment according to applicable regulations

FAQ

Q1: Is ce marking equivalent to certification approval?

No. ce marking is a manufacturer’s self-declaration that the product complies with relevant regULations, not a license or approval granted by a certification body.

Q2: When should the CE mark be affixed?

The CE mark should only be affixed when the product meets the requirements of one or more relevant EU harmonization regulations. It must not be affixed to products not coveRED by the EU CE series regulations without authorization.

Q3: Where do I need to purchase the CE mark?

No purchase is required. Manufacturers may download the template and print it in proportion in accordance with regulations. However, they must ensure that the product meets all applicable regulatory requirements. It can be downloaded from the official website:

https://single-market-economy.ec.europa.eu/single-market/ce-marking_en

Q4: Is the conformity assessment process for CE marking complicated?

It depends on the product category; some products must undergo conformity assessment by a notified body.

Q5: What are the consequences of improper use of the CE mark?

EU member states are responsible for ensuring the correct use of the CE mark and have the right to take corresponding regulatory measures when violations are found, such as fraudulent affixing, failure to complete conformity assessment procedures, or inconsistency between product information and the Declaration of Conformity.

Some products need to comply with multiple EU requirements simultaneously. You must ensure that your product meets all relevant requirements before affixing the CE mark. As a manufacturer, before affixing the CE mark, you must:

①　Identify the applicable directives/regulations and harmonized standards;

②　Verify the specific requirements for the product;

③　Confirm whether independent conformity assessment by a notified body is required;

④　Test the product and check its compliance;

⑤　Prepare and properly keep the required technical documentation (for technical documentation requirements, please refer to Technical Documentation);

⑥　Affix the CE mark, draw up and sign the EU Declaration of Conformity.

Once your product bears the CE mark, you must provide all relevant information and supporting documents regarding the CE mark to the national authorities upon their request.