CE Mark Directives
If you’re involved in creating, selling, or distributing electrical products within the European Union (EU) and United Kingdom (UK), before applying the CE mark to your products, start by understanding the proper usage of CE marking. We start with directives, which provide the framework for ensuring your products align with the EU’s safety, quality, and environmental standards. Only products that fall into control of a CE directive or directives should apply the CE mark.
CE Directives
| The below lists the full list of CE Directives laid down by the New Legislative Framework and for the general application of market surveillance provisions according to Regulation (EU) 2019/1020: —The restriction of the use of certain hazardous substances in electrical and electronic equipment (Directive 2011/65/EU) —Appliances burning gaseous fuels (Regulation (EU) 2016/426) —Ecodesign requirements for energy-related products (Directive 2009/125/EC and all implementing Regulations for specific product groups that have been adopted under this Framework Directive) —Simple pressure vessels (Directive 2014/29/EU) —Toys’ safety (Directive 2009/48/EC) —Electrical equipment designed for use within certain voltage limits (Directive 2014/35/EU) —Machinery (Directive 2006/42/EC) —Electromagnetic compatibility (Directive 2014/30/EU) —Measuring instruments (Directive 2014/32/EU) —Non-automatic weighing instruments (Directive 2014/31/EU) —Cableway installations (Regulation (EU) 2016/424) —Radio equipment (Directive 2014/53/EU) —Medical devices (Regulation (EU) 2017/745, replacing Directives 90/385/EEC and 93/42/EEC as of 26 May 2021) —In vitro diagnostic medical devices (Directive 98/79/EC to be replaced by Regulation (EU) 2017/746 as of 26 May 2022) —Pressure equipment (Directive 2014/68/EU) —Transportable Pressure equipment (Directive 2010/35/EU) —Aerosol Dispensers (Directive 75/324/EEC as amended) —Lifts (Directive 2014/33/EU) —Recreational craft (Directive 2013/53/EU) —Equipment and protective systems intended for use in potentially explosive atmospheres (Directive 2014/34/EU) —Explosives for civil uses (Directive 2014/28/EU) —Pyrotechnics (Directive 2013/29/EU) —Regulation on the Labelling of Tyres (Regulation (EU) No 2020/740) —Personal protective equipment (Regulation (EU) 2016/425) —Marine equipment (Directive 2014/90/EU) —Noise emission in the environment by equipment for use outdoors (Directive 2000/14/EC) —Emissions from non-road mobile machinery (Regulation (EU) 2016/1628) —Energy labelling (Regulation (EU) 2017/1369 and all delegated Regulations for specific product groups that have been adopted under this Framework Regulation and those adopted under Directive 2010/30/EU, the predecessor of Regulation 2017/1369)—Fertilising Products (Regulation (EU) 2019/1009) —Unmanned aircraft systems (drones) (Commission Delegated Regulation (EU) 2019/945) |
Low Voltage Directive – 2014/35/EU
Objective: The Low Voltage Directive (LVD) is designed to ensure the safety of electrical equipment intended for use within specified voltage limits. Its primary aim is to protect users from electrical hazards and risks associated with low voltage equipment.
Compliance/Requirement: Manufacturers must ensure that their electrical products falling within the defined voltage range (50V to 1000V AC, 75V to 1500V DC) meet essential safety requirements. This involves thorough risk assessments, designing products to minimize electrical risks, and conducting necessary tests to verify compliance. Once conformity is established, the CE mark can be affixed, indicating compliance with the LVD and eligibility for the EU market.
EMC Directive – 2014/30/EU
Objective: The Electromagnetic Compatibility Directive (EMC) aims to prevent electromagnetic interference between different electrical and electronic devices. It ensures that products can function correctly without causing or being affected by excessive electromagnetic emissions.
Compliance/Requirement: Manufacturers must demonstrate that their electrical products are designed to minimize electromagnetic interference and to operate harmoniously in an electromagnetic environment. Compliance involves conducting tests to evaluate emissions and immunity to interference. By meeting these standards, products can be marked with the CE symbol, signifying their conformity to EMC requirements and their readiness for the EU market.
Radio Equipment Directive – 2014/53/EU
Objective: The Radio Equipment Directive (RED) is established to ensure the compatibility, safety, and efficient use of radio equipment within the European Union (EU). Its primary aim is to promote the availability of radio equipment that meets essential requirements, while also safeguarding users and minimizing electromagnetic interference.
Compliance/Requirement: Manufacturers of radio equipment are required to demonstrate that their products meet essential requirements related to safety, electromagnetic compatibility, and efficient spectrum use. Importantly, when a product conforms to the RED, it automatically satisfies the requirements of the Low Voltage Directive (LVD) and the Electromagnetic Compatibility Directive (EMC). Compliance entails testing and assessment to ensure that radio equipment functions reliably, does not pose hazards to users, and does not cause undue electromagnetic interference. Once conformity is achieved, the product can bear the CE marking, indicating compliance with the RED, LVD, and EMC Directive, and eligibility for placement on the EU market.
RoHS Directive – 2011/65/EU
Objective: The Restriction of Hazardous Substances (RoHS) Directive focuses on reducing environmental and health hazards by restricting the use of hazardous substances in electrical and electronic equipment. Its goal is to minimize the presence of harmful substances in electronic waste.
Compliance/Requirement: Manufacturers, importers, and distributors are responsible for ensuring that their electrical products do not contain restricted substances such as lead, mercury, cadmium, and certain flame retardants beyond specified limits. Complying with RoHS involves conducting material analysis and adhering to the substance restrictions. Products that meet RoHS criteria can be marked with the CE label, indicating adherence to these regulations.
WEEE Directive – 2012/19/EU
Objective: The Waste Electrical and Electronic Equipment (WEEE) Directive addresses the proper management, disposal, and recycling of electronic waste, minimizing its impact on the environment and human health.
Compliance/Requirement: Manufacturers are often required to establish take-back systems to ensure the proper collection and recycling of their electrical products at the end of their life cycle. They must provide information about proper disposal methods and contribute to the sustainable handling of electronic waste. By complying with the WEEE Directive, manufacturers contribute to a greener future and demonstrate their commitment to environmental responsibility. Products that meet the WEEE directive requirements can apply the Recycle Bin mark and CE mark.
Demonstrating Compliance and Proof of Conformity
When it comes to ensuring your electrical products meet the requirements of the CE mark directives, demonstrating compliance is a critical step. The proof of conformity not only establishes the quality and safety of your products but also instills confidence in your customers and partners. There are several ways to showcase compliance, each suited to different scenarios. Here, we outline the three main methods: Manufacturer Declaration of Conformity, Lab Verification of Conformity, and Notified Body Certificate.
Manufacturer Declaration of Conformity
The Manufacturer Declaration of Conformity is a self-certification process in which the manufacturer takes responsibility for assessing and ensuring that their product complies with the applicable directives. Here’s how it works:
Assessment: Manufacturers conduct internal assessments, perform necessary tests, and ensure their product aligns with the essential requirements of the relevant directive(s).
Documentation: Manufacturers compile a Technical File containing all relevant documentation, such as technical specifications, test reports, and risk assessments.
CE Marking: Upon confirming conformity, the manufacturer affixes the CE mark to their product, indicating compliance with the directive(s).
Traceability: Manufacturers must maintain the Technical File and be prepared to present it upon request by authorities or market surveillance.
Pros:
Control and Speed: Manufacturers have direct control over the assessment process, allowing for quicker time-to-market.
Flexibility: Suited for products with established compliance history or when testing requirements are well-understood.
Responsibility: Manufacturers take full responsibility for compliance, demonstrating their commitment to product quality.
Cons:
Limited Independence: Self-assessment might lack the third-party validation sought by some customers.
Costly Equipment: Assessing complex products might require specialized expertise and testing equipment.
Lack of Recognition: Many countries either endorse CE mark or will recognize CE testing reports as documented proof that the product is in conformity with international harmonized standards. Most internal testing lab, lack ISO17025 accreditation, rendering the testing reports un-usable when beyond EU and UK borders.
Lab Verification of Conformity
Lab Verification of Conformity involves having an ISO17025 accredited testing laboratory assess your product’s compliance. This method is often preferred when a third-party evaluation is desired:
Testing: The accredited testing laboratory performs necessary tests on your product, evaluating its performance, safety, and compliance with the directive(s).
Test Reports: The laboratory provides detailed test reports and documentation of the evaluation process.
CE Marking: With a successful verification, the manufacturer can affix the CE mark to their product and provide the associated test reports as proof of compliance.
Pros:
Third-Party Validation: Testing by ISO17025 accredited labs provides an independent confirmation of compliance.
Expertise: Lab personnel are experts in testing and compliance, ensuring thorough evaluation.
Credibility: Third-party test reports enhance product credibility and can improve market acceptance.
Internationally Recognized: Testing reports issued by ISO17025 accredited labs are internationally recognized by various international regulatory agencies.
Efficiency: Manufacturers can focus on product development while experts handle compliance testing.
Cons:
Cost: Engaging an external testing lab can lead to increased costs compared to internal assessment.
Time: Coordination with testing labs might extend time-to-market, especially for time-sensitive projects.
Limited Control: Manufacturers have limited control over testing procedures and processes.
Since we are in the business of compliance project coordination, our honest opinion is that most of the “Cons” of using a 3rd Party Lab for Verification of Conformity can be kept to a minimum and should even be all “Pros” if you are working with the right compliance partners who will make it more cost saving, time efficient, and will work with you to give you full control over project.
Notified Body Certificate
Certain high-risk or complex products like Medical Devices require involvement from a Notified Body, an independent organization designated by the European Union to assess conformity:
Application: Manufacturers apply to a Notified Body for assessment, providing all relevant technical documentation.
Evaluation: The Notified Body reviews the technical documentation, conducts necessary tests, and assesses compliance with the directive(s).
Certificate: Upon successful evaluation, the Notified Body issues a conformity certificate, confirming the product’s compliance.
CE Marking: The manufacturer can affix the CE mark to the product and reference the Notified Body’s certificate as proof of compliance.
Pros:
High Credibility: Notified Body involvement provides a strong endorsement of product compliance.
Complex Products: Suitable for high-risk, complex products where independent assessment is crucial.
International Acceptance: Notified Body certificates are widely recognized across the EU and beyond.
Liability Sharing: The Notified Body shares some legal liability, which can be advantageous.
Cons:
Cost and Time: Involvement of a Notified Body can significantly increase costs and extend timeframes.
Resource Intensive: The application process and documentation requirements can be demanding
Selecting the Right Approach
The choice of method depends on factors such as the complexity of your product, preferences, market expectations, and regulatory requirements. Regardless of the method chosen, the ultimate goal remains the same: ensuring your electrical products are safe, reliable, and in compliance with the CE mark directives.
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