The CE mark is a mandatory European marking for certain product groups to indicate conformity with the essential requirements set out in European Directives. In order to use the CE approval mark on a product, the manufacturer must draw up an EU declaration of conformity (DoC) in which the manufacturer attests conformity with all relevant New Approach Directives (NADs) and takes sole legal responsibility. In some instances, a NAD may require a Notified Body to issue a Certificate of EU declaration of conformity (DoC) Conformity in order to verify performance of the product or constancy of the production process (Factory Production Control, for example).
F2 Labs can assist you in identifying the requirements for CE certification, including CE testing. We have an experienced staff of experts in CE compliance ready to assist you throughout the process of CE mark testing – including the bid phase of your potential project to obtain the CE certification. With more than 20 years of experience in CE compliance testing and evaluation, F2 Labs has helped many businesses successfully enter into the European and global markets.
We test products to the following directives:
- Radio Equipment Directive 2014/53/EU (RED), formerly R&TTE Directive
- EMC Directive 2014/30/EU (formerly Directive 2004/108/EC)
- (ATEX) Directive 2014/34/EU (formerly Directive 94/9/EC)
- General Product Safety Directive 2001/95/EC (this Directive does not involve applying a CE mark but can be applicable to your product)
- Low Voltage Directive 2014/35/EU (formerly Directive 2006/95/EC)
- Machinery Directive 2006/42/EC
- Medical Devices 93/42/EEC
Steps to Obtaining the CE Mark
F2 Labs will walk you through each step of the CE mark testing process:
- Identify the directive(s) and harmonized standards applicable to the product
- Verify the product-specific requirements
- Identify whether a Notified body approval is required
- Test the product to check its conformity
- Compile and keep available the required technical documentation
- Affixation of the CE mark to your product and complete an EU declaration of conformity.
The EU declaration of conformity (DoC) must include: manufacturer’s details (name, address, etc.); description of the product; List of EU Directives to which the product complies; list of relevant EN standards used; must be signed and dated by an authorized representative of the company placing the product on the European Market, and must be translated into the native language of the country in which it will operate.
The CE mark is covered by Council Decision 93/465/EC. Annex B(d) provides the following guidelines:
- The CE conformity marking must consist of the initials ‘CE’ taking the following form:
- If the CE conformity marking is reduced or enlarged the proportions must be kept the same.
- Where the directive concerned does not state specific dimensions, the CE marking must have a height of at least 5 mm.
- The CE marking must be affixed to the product or to its data plate. However if that is not possible or warranted on account of the nature of the product, it must be affixed to the packaging, if any, and to the accompanying documents, where the directive concerned provides for such documents.
- The CE marking must be affixed visibly, legibly and indelibly.
CE Mark Testing
- EU Directive Testing – F2 Labs has more than 20 years of experience in assisting our clients with European product compliance evaluation and testing to the applicable EN standards under the EU Directives so that they can obtain the CE mark for their product(s).
- EMC Directive 2014/30/EU (formerly Directive 2004/108/EC) – F2 Labs can perform Electromagnetic Compatibility (EMC/EMI) testing of your product at our facility or on-site at your facility.
- Low Voltage Directive 2014/35/EU (formerly Directive 2006/95/EC) – F2 Labs can provide the testing services you need in order to prove that your product is compliant with the Low Voltage Directive.
- Machinery Directive 2006/42/EC Evaluation & Testing – F2 Labs can perform the evaluation and testing required by the Machinery Directive at our facility or yours.
- EU Authorized Representative – F2 Labs offers can serve as your Authorized EU Representative serving as the contact point.
- Medical Device Directive 93/42/EEC – Manufacturers must comply with the medical device directive in order to sell their medical products into Europe.
- Radio Equipment Directive 2014/53/EU (RED), formerly R&TTE Directive – F2 Labs can assist you with your Radio Equipment Directive 2014/53/EU (RED), formerly R&TTE Directive, testing needs.
- General Product Safety Directive 2001/95/EC – Although this Directive does not involve CE marking the product, it may be a requirement for your European compliance project. F2 Labs can assist you with testing required for compliance to the General Product Safety Directive.