Manufacturers that want to sell products in the European Union and European Economic Area (EEA) must demonstrate compliance with European regulatory requirements before entering the market. CE marking confirms that a product meets the environmental, health, safety, and protection standards as defined by EU directives and regulations.
F2 Labs provides accredited CE compliance testing and CE mark certification services to help manufacturers achieve regulatory approval efficiently and confidently. With ISO/IEC 17025–accredited laboratories in Maryland, Ohio, and Indiana and more than 30 years of regulatory testing experience, we guide manufacturers through the complete CE certification process—from early product design review to final conformity documentation.
Our laboratories perform EMC testing, electrical safety testing, radio/wireless testing, and directive-specific evaluations required for CE marking. Whether your product is an electronic device, wireless system, industrial machine, or medical device, F2 Labs provides the testing infrastructure and regulatory expertise needed to achieve CE certification and access European markets.
What Is CE Compliance?
CE compliance is the process of verifying that a product satisfies the essential requirements defined by European Union directives and regulations. Products that fall under these directives must meet strict safety, electromagnetic compatibility, environmental, and performance requirements before they can legally be sold in the European market.
The CE mark—short for Conformité Européenne—is the manufacturer’s declaration that the product complies with all applicable EU legislation.
Products without CE compliance may face:
- Import restrictions or customs seizure
- Regulatory penalties and product recalls
- Legal liability for manufacturers and distributors
Beyond regulatory requirements, CE certification is also an important signal of product safety and reliability for distributors, integrators, and consumers across Europe.
What products require CE Certification?
Many product categories require CE marking before entering the EU market. Common examples include:
- Wireless communication devices
- Consumer electronics
- Industrial machinery
- Medical devices
- Laboratory equipment
- Power supplies and electrical equipment
- Sensors and IoT devices
- Automation and robotics equipment
Because many products fall under multiple EU directives simultaneously, determining applicable regulatory requirements is often the most complex step in the CE compliance process. For example, a wireless medical device may need to comply with the Medical Device Regulation, the Radio Equipment Directive, and the Restriction of Hazardous Substances Directive, each imposing distinct testing and documentation obligations.
F2 Labs helps manufacturers identify the applicable directives and standards to ensure complete regulatory compliance.
CE Certification Services
What EU Directives do you evaluate electrical products for?
Products that intentionally transmit or receive radio signals must comply with the Radio Equipment Directive before carrying the CE mark.
Examples include:
- Wi-Fi devices
- Bluetooth devices
- Cellular equipment
- RFID systems
- Zigbee and LoRa devices
- IoT sensors
F2 Labs performs RED testing, including:
- Transmitter power measurements
- Spurious emission testing
- Receiver performance evaluation
- Electromagnetic compatibility testing
- Radio spectrum compliance verification
Our engineers test wireless devices to applicable EN harmonized standards and can coordinate multi-market approvals, including FCC and ISED Canada certifications.
- Radiated emissions (EN 55011)
- Conducted emissions (EN 55011)
- Electrostatic discharge (ESD) (EN 61000-4-2)
- Electrical fast transient/burst (EFT) (EN 61000-4-4)
- Surge immunity (EN 61000-4-5)
- Radiated immunity (EN 61000-4-3)
- Conducted immunity (EN 61000-4-6)
- Magnetic fields Immunity (EN 61000-4-8)
- Voltage dips/interrupts (EN 61000-4-11)
- Flicker/voltage fluctuation emissions (EN 61000-3-3)
- Harmonic current emissions (EN 61000-3-2)
Electrical products operating within specified voltage ranges must comply with the Low Voltage Directive to ensure protection from electrical hazards.
F2 Labs performs safety testing including:
- Electrical insulation testing
- Dielectric strength testing
- Temperature rise testing
- Mechanical hazard evaluation
- Abnormal condition testing
- Humidity conditioning
- Drop temperature
- Spacings
- And more
These evaluations verify that products meet applicable EN safety standards and protect users from electrical and thermal risks.
Industrial machinery and automated systems must comply with the Machinery Directive before entering the European market.
F2 Labs supports manufacturers with:
- Risk assessment according to EN ISO 12100
- Functional safety evaluation
- Electrical safety testing
- Machinery compliance consulting
- On-site testing for large equipment
For machinery that cannot be shipped, our engineers perform on-site compliance testing directly at the manufacturer’s facility.
Equipment used in potentially explosive atmospheres must comply with the ATEX Directive.
Examples include equipment used in:
- Oil and gas environments
- Chemical processing facilities
- Mining operations
- Dust-hazard industrial environments
F2 Labs assists with:
- Hazard classification
- Equipment category identification
- ATEX testing
- Compliance documentation
Medical electrical equipment sold in Europe must comply with the Medical Device Regulation (MDR).
F2 Labs provides testing to the IEC 60601 family of standards, including:
- IEC 60601-1 (medical electrical safety)
- IEC 60601-1-2 (EMC requirements)
- Particular medical device standards
Our test programs can support both EU CE certification and U.S. FDA submissions.
Restriction of the Use of Certain Hazardous Substances (RoHS) Directive 2011/65/EU
Electrical and Electronic Equipment (EEE) must comply with the RoHS Directive, which restricts the use of hazardous substances in these products. The directive aims to protect human health and the environment by promoting the safe recovery and disposal of EEE waste.
Categories of EEE covered by this Directive
- Large household appliances
- Small household appliances
- IT and telecommunications equipment
- Consumer equipment
- Lighting equipment
- Electrical and electronic tools
- Toys, leisure and sports equipment
- Medical devices
- Monitoring and control instruments including industrial monitoring and control instruments
- Automatic dispensers
- Other EEE not covered by any of the categories above
What are the steps to the CE certification process?
Achieving CE Certification involves several structured steps.
- Step 1 – Identify Applicable EU Directives. Engineers determine which EU directives apply based on product function, design, and intended use.
- Step 2 – Determine Applicable Harmonized Standards. Applicable EN standards define the testing methods and performance requirements.
- Step 3 – Perform CE Compliance Testing. Accredited laboratories perform EMC, safety, radio, and environmental testing, as applicable.
- Step 4 – Evaluate Results and Address Compliance Issues. Design changes may be required to resolve compliance failures.
- Step 5 – Compile Technical Documentation. Manufacturers must maintain a technical file containing test reports, risk assessments, and product documentation.
- Step 6 – Issue the EU Declaration of Conformity. The manufacturer formally declares compliance with all applicable directives.
- Step 7 – Affix the CE Mark. Once compliance is confirmed, the CE mark can be applied to the product.
Why do manufacturers choose F2 Labs for CE Compliance?
Accredited, Purpose-Built Testing Facilities
Our ISO/IEC 17025 accredited laboratories provide the testing infrastructure and expertise required for CE certification.
30+ Years of Regulatory Expertise
Our engineering team has helped thousands of manufacturers successfully navigate EU compliance requirements.
Multi-Market Certification
We support certification for:
- CE Mark
- FCC certification
- ISED Canada certification
- RCM certification
- Certification to UL and CSA standards for the North America
This allows manufacturers to complete global regulatory approvals with a single testing partner.
On-Site CE Testing Capabilities
For large machinery and integrated systems, our engineers perform compliance testing directly at the manufacturer’s facility. We are accredited for on-site testing, as well.
Medical Device Expertise
Our FDA ASCA accreditation allows medical device manufacturers to streamline regulatory approvals across multiple markets.
EU Directives Tested at Our CE Mark Testing Lab
CE Mark Testing Lab
EU Directive Testing – F2 Labs has more than 20 years of experience in assisting our clients with CE testing certification, 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) -Our CE Mark Testing Lab 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 CE certification 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 Regulation 2023/988 – Although this Directive does not involve CE marking the product, it may be a requirement for your European compliance project. Our CE Mark Testing Lab can assist you with testing required for compliance with the General Product Safety Directive.
WEEE Directive 2012/19/EU Testing – F2 Labs sales and engineering staff is always available to assist you with your European projects. We can talk with you regarding these WEEE disposal laws and offer our best guidance.
RoHS Directive 2011/65/EU – RoHS is a CE marking Directive and if your product is within its scope then it must carry a CE marking and be referenced on an accompanying declaration of conformity.
Food Contact Materials Regulation (EC) 1935/2004 – The European Union has specific legislation for equipment and products that come into contact with food and it has its own mark. F2 Labs can assist you with the compliance requirements for this regulation.
Start Your CE Compliance Project with F2 Labs
F2 Labs provides CE certification services for products at every stage, from early design review and prototype pre-testing to final conformity assessment and documentation. Whether you need CE testing for a single directive or a multi-directive compliance program spanning EMC, safety, radio, and environmental requirements, our team is ready to scope your project and deliver a detailed quote.
Contact F2 Labs today to speak with a CE compliance engineer and take the first step toward European market entry.
FAQs
What is the CE Mark?
The CE mark is a mandatory European marking that indicates a product conforms to the essential requirements set out in European Directives. It demonstrates compliance with EU safety, health, and environmental protection standards.
What is the cost of CE Certification?
CE certification costs vary depending on several factors:
- Product complexity
- Applicable directives
- Required testing standards
- Number of product variants
- Whether a Notified Body is required
For simple electronic devices, testing may take several days. More complex systems such as medical devices or industrial machinery may require extended evaluation.
F2 Labs provides project scoping and cost estimates before testing begins.
How long does the CE Certification take?
Typical timelines include:
-
Pre-compliance testing: 1–2 weeks
- Preliminary documentation design review: 1-2 weeks
- Full compliance testing: 2–8 weeks
Collaborating with an experienced laboratory is essential to mitigate common delay risks, such as those arising from non-compliance with technical requirements, incomplete or insufficient documentation, and the need for retesting due to failed initial assessments. By leveraging expert guidance throughout the testing and certification process, manufacturers can preemptively address potential compliance gaps and documentation errors, thereby streamlining project timelines and reducing the likelihood of regulatory setbacks.
What Products Require the CE Mark?
Products that fall under one or more of the EU’s harmonization directives and regulations must carry the CE mark. Common examples include products regulated by the:
- Radio Equipment Directive
- EMC Directive
- ATEX Directive
- Low Voltage Directive
- Machinery Directive (transitioning to the Machinery Regulation in January 2027)
- Medical Device Regulation
If your product falls under one of these or other applicable directives, it must comply with the relevant requirements to carry the CE mark.
What is an EU Declaration of Conformity (DoC)?
The EU Declaration of Conformity (DoC) is a document in which the manufacturer declares that the product meets all relevant EU directives and regulations. This document is a mandatory step before affixing the CE mark and confirms that the manufacturer assumes full legal responsibility for compliance.
When is a Notified Body Required for CE Certification?
A Notified Body is required when certain EU directives or regulations mandate third-party conformity assessment. This may include assessments such as:
- Factory production control
- Type-examination or performance testing for specific product categories
If your product falls under these requirements, working with a Notified Body ensures compliance. F2 Labs can advise you on whether Notified Body involvement is necessary for your product.
How Should the CE Mark Be Affixed?
The CE mark must be:
- Visible, legible, and indelible on the product or its data plate.
- Affixed to the packaging or accompanying documents if not feasible on the product.
- Maintained with proportions specified in the directive.
- At least 5mm in height if no specific dimensions are stated.
What Should Be Included in the EU Declaration of Conformity?
The EU Declaration of Conformity (DoC) must include:
- Manufacturer’s details (name and address)
- Product description
- List of relevant EU Directives and EN standards complied with
- Authorized representative’s signature and date
- Translation into the local language of the country of operation
Check the specific directives applicable to your product for exact requirements.
