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    CE Certification

    What Is CE Certification?

    When entering the market of the countries of the European Union (EU) and the European Economic Area (EEA), goods of certain categories require the CE marking. This abbreviation stands for “European Conformity” (Conformité Européenne) and serves as proof that the product has been tested for compliance with all EU Directives. This practice was introduced in 1985 to accredit market access for both domestic and foreign producers. The CE mark on a product means that it complies with all established EU regulations regarding the safety of human health and the environment.

    CE EMC Certification

    What is CE EMC Certification? CE EMC Certification is a mark that indicates a product's compliance with Electromagnetic Compatibility (EMC) requirements in the European Union. EMC is crucial because electronic devices emit electromagnetic waves during operation, and without proper EMC measures, these emissions can lead to Electromagnetic Interference (EMI). The CE mark, which stands for Conformité Européenne, is a mandatory certification for products sold within the European Economic Area (EEA). It signifies that a product meets the essential EMC standards set by the European Union to ensure that it won't cause or be susceptible to electromagnetic interference. This interference could affect the proper functioning of other nearby electronic devices. The certification process is guided by Directive 2014/30/EU, which outlines the specific EMC requirements that products must meet to obtain the CE mark. This directive establishes the legal framework for electromagnetic compatibility and mandates that manufacturers thoroughly test their products for compliance. The goal is to guarantee that electronic devices can coexist harmoniously in the European market without causing disruption or compromise in functionality. Which Products Need the CE EMC Mark? If your product falls into the category of devices that can emit electromagnetic waves during operation, it likely requires the CE EMC mark. Here are some examples of products that typically need this certification: Electrical Appliances: Household appliances such as washing machines, refrigerators, and microwave. Information Technology Equipment: Computers, laptops, servers, and networking equipment. Consumer Electronics: This includes a broad range of devices like televisions, audio equipment, and gaming consoles.  Medical Devices: Equipment used in the medical field, such as diagnostic machines and monitoring devices. Telecommunications Equipment: Phones, routers, and other communication devices. Industrial Machinery: Various types of machinery used in industrial settings, like manufacturing equipment and automation systems. Lighting Products: From simple light bulbs to complex lighting systems. Electronic Toys: Children's toys that incorporate electronic components or emit electromagnetic signals during play. Why is EMC CE Testing Important? Ensuring Market Access: Legal Compliance: CE EMC Certification is a legal requirement for placing products in the EU market. Non-compliance can result in serious consequences, including fines and withdrawal of products from the market. Enhanced Market Credibility: Products with CE EMC Certification signal adherence to high-quality standards, enhancing your brand's credibility and customer trust. Quality Assurance: Product Reliability: EMC Certification ensures that your products can function in the presence of electromagnetic disturbances, making them more reliable. Reduced Interference: Certification reduces the risk of your products causing interference with other electronic devices, preventing potential issues for end-users. How to Get CE EMC Certification? Step-by-Step Guidance: Consultation: Initiate the process with a consultation to understand your product and specific certification needs. Pre-assessment: Identify potential EMC issues and address them before formal testing to expedite the certification process. Testing and Evaluation: Utilize our accredited laboratories for comprehensive emissions and immunity testing. Documentation Support: Our team assists in preparing the necessary technical documentation required for certification. Declaration of Conformity: Once certified, we help you issue the Declaration of Conformity and affix the CE mark to your product. How long will testing take? The EMC CE certification procedure takes 4 to 6 weeks on average. If the product belongs to an industry that is regulated by other directives (e.g. CE RED), it is subject to additional tests, which increases the time required. Manufacturer's Responsibilities Related to EMC CE Certification The company that develops a product shall design it according to EMC CE norms and confirm compliance with the norms by independent laboratory tests. It is also required to: indicate the actual electromagnetic radiation level in the documentation; warn about the possible hazards associated with the use of the device; provide the user with operating instructions; indicate geographical restrictions on the use of the product, if any; keep a register of complaints; store certificates and declarations of conformity for at least 10 years; cooperate with local authorities and provide product samples to the authorities. Quick and Easy EMC CE Certification with 360Compliance Obtaining CE EMC Certification is not just a regulatory obligation; it is a strategic move to ensure your products' quality, compliance, and market competitiveness. By investing in certification, your business can access new markets, build trust with customers, and stay ahead in the dynamic world of electronics. At 360Compliance, we simplify the process, offering expert guidance and tailored solutions to ensure your products meet the highest standards of electromagnetic compatibility. Contact us to get transparent pricing, clear timelines, and technical support at all stages of the procedure.

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    CE LVD Certification

    What is CE LVD Certification? CE LVD Certification, governed by the Low Voltage Directive 2014/35/EU, is a critical quality assurance process for manufacturers seeking to market their electrical products in the European Union (EU). The acronym "LVD" refers to the Low Voltage Directive, initially adopted in 1973 and subsequently amended to set stringent rules for the quality testing of electronic tools. The primary objective of CE LVD Certification is to ensure the safety of electrical equipment sold within the EU. It is a mandatory requirement for all manufacturers, importers, and distributors, covering a broad spectrum of products from AC adapters to household appliances. The certification process involves adherence to specific technical standards issued by the International Electrotechnical Commission (IEC) and includes comprehensive documentation, design specifications, and conformity testing. The CE LVD Certification is represented by the CE mark, which indicates compliance with safety regulations and allows market access in the EU. Which Products Need LVD CE Certification? Compliance testing under the Low Voltage Directive 2014/35/EU is mandatory for electrical items falling within the voltage limits of 50 – 1,000 volts for AC gadgets and 75 – 1,500 volts for DC gadgets. Obtaining the CE certification for the Low Voltage Directive is crucial to ensure compliance with EU regulations for product safety. This certification is particularly relevant for products that fall within the scope of electrical equipment operating within specific voltage limits. Here is a list of products that commonly require LVD CE certification: Consumer Electronics: Devices such as smartphones, laptops, and tablets. Power Supplies: Devices providing electrical power, including power adapters and chargers. Household Appliances: From kitchen appliances like blenders and toasters to larger devices like washing machines and refrigerators. Lighting Products: Whether it's traditional light bulbs or modern LED fixtures. Power Tools: Electric drills, saws, and other power tools. Industrial Machinery: Electrical machinery used in industrial settings, such as manufacturing plants. Audio and Video Equipment: Products like amplifiers, speakers, and televisions. IT Equipment: Servers, networking equipment, and other information technology products. Electrical Toys: Children's toys that include electrical components or operate on electricity. Automotive Electronics: Certain electrical components and systems that are present in vehicles, such as navigation systems and entertainment units.   Which products are not covered by the LVD? There are some exceptions and specific types of equipment that fall outside the scope of the LVD. Here are examples of products generally not covered by the LVD: Equipment for Special Purposes: Electrical equipment designed for certain specific applications, such as explosive atmospheres, medical devices, and military equipment. Aircraft and Aerospace Equipment: Electrical equipment intended for use in aircraft and aerospace applications. Radio and Telecommunications Terminal Equipment: Equipment covered by the Radio Equipment Directive (RED) and the Electromagnetic Compatibility Directive (EMC) falls outside the scope of the LVD. Plugs and Socket-Outlets for Domestic Use: These are excluded from the LVD and may be subject to other standards or regulations. Custom-Built Evaluation Kits for Professionals: Products designed for professionals for research and development purposes, provided they are not intended for end-user markets.   How to Pass the LVD Certification: To obtain LVD certification, companies must submit comprehensive technical documentation outlining the device, its design, manufacturing process, and operational principles. Products are subject to conformity tests, including: humidification, ball pressure, insulation resistance, glow wire, power measurement, needle flame, air conditioning, warming, mechanical, leakage current. Companies can ensure a smoother certification process by seeking expert advice to navigate complexities and ensure adherence to safety regulations. Why Is a CE Low Voltage Mark Important? The CE Low Voltage Mark is a visual indication that your electrical equipment complies with the essential safety requirements of the Low Voltage Directive. This mark is a testament to the quality and safety of your products, instilling confidence in both consumers and regulatory authorities. It opens doors to international markets by demonstrating that your products meet the stringent safety standards set by the European Union. At 360Compliance, we understand the importance of CE LVD Certification for your business. Let us be your partner in achieving compliance, and ensuring the safety and success of your electrical products in the global market. Explore our services today and embark on a journey to certification excellence. Contact us to achieve CE LVD Certification.

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    CE Certification For Medical Devices

    What is CE MD Certification? CE MD certification is a mandatory requirement for all medical devices that are sold in the European Union. The CE mark is a symbol that indicates that a product has met all of the applicable EU directives and regulations. To obtain CE marking for medical devices, manufacturers must adhere to the regulatory framework outlined in the Medical Devices Regulation (MDR) or the In Vitro Diagnostic Regulation (IVDR). The primary objective of CE approval for medical devices is to ensure the safety, effectiveness, and alignment with the needs of patients and healthcare professionals. The process is regulated by EU Directive 2017/745 and relevant industry regulations, including 90/385/EEC, 93/42/EEC, 98/79/EC, and 722/2012. Which Products Require MDR CE Marking? CE MD marking is mandatory for a wide range of medical devices, including but not limited to: Diagnostic Equipment; Implants; Surgical Instruments; Monitoring Devices; Dental Products; Rehabilitation Equipment. Manufacturers must ensure their products align with specific classifications and requirements outlined in the applicable directives. Which products do not need the CE MD Mark? CE medical device certification is unnecessary if the product does not meet the definition of a medical device outlined in EU Directive 2017/745 (MDR). In that case, other industry regulations, like those governing radio frequency or electromagnetic radiation, are applicable. Additionally, products can be sold without a CE certificate if alternative standards have been set for them, as seen with medicines, food products, cosmetics, and chemicals. CE Certification Process for Medical Devices The CE certification process for medical devices involves several key steps: Legal Requirement CE marking is mandatory for medical devices under the EU Medical Devices Regulation (MDR) or the In Vitro Diagnostic Medical Devices Regulation (IVDR), depending on the nature of the product. Conformity Assessment To obtain CE marking, manufacturers must undergo a conformity assessment, which involves demonstrating that the medical device complies with the relevant essential requirements and standards. Particularly the IEC 60601 series, which specifically addresses the safety and essential performance of medical electrical equipment. Classification of Devices Classifying devices involves categorizing medical devices into different classes based on their risk level. The classification determines the conformity assessment procedure that the manufacturer must follow. Technical Documentation Manufacturers must create and maintain technical documentation supporting the conformity of the medical device. This documentation should cover aspects such as design, manufacturing, risk assessment, and labeling. Notified Bodies In many cases, a Notified Body, an independent third-party organization, is involved in the conformity assessment process. The Notified Body assesses the technical documentation and issues a certificate if the requirements are met. Post-Market Surveillance CE marking is not a one-time event. Manufacturers must continue to monitor their products after they enter the market. Post-market surveillance involves tracking the device's performance, addressing any safety concerns, and updating documentation as needed. Unique Device Identification (UDI) The EU MDR and IVDR require the use of a Unique Device Identification system, allowing for traceability and improved post-market surveillance. The timeframe for issuing the certificate varies depending on the niche and the application of the device. The average time for a Class A device is 4 to 8 weeks. Clinical testing of Class B and C devices can take several months. Benefits of CE Certification for Medical Devices Market Access Achieving CE certification opens the doors to the vast European market, allowing manufacturers to distribute and sell their medical devices within the EU. Compliance with Regulations CE certification ensures that your medical device complies with the stringent regulations and standards set by the European authorities, fostering trust among healthcare professionals and end-users. Enhanced Reputation Displaying the CE mark on your medical devices demonstrates a commitment to quality and safety, enhancing your brand's reputation in the competitive healthcare industry. Risk Mitigation Compliance with CE mark medical device requirements helps mitigate legal and financial risks associated with non-compliance, ensuring that your products meet the highest safety and performance standards. Quick CE MD Certification with 360Compliance We provide a full range of CE certification services for medical devices. Our employees provide assistance with all the stages of this procedure from evaluating the legal environment and determining the class of equipment to the paperwork and cooperation with authorized bodies. We guarantee transparent prices, clear deadlines, and convenient technical support. Get your certificate quickly and with a minimum of effort by leaving an application on our website to learn more about our services!

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    CE RED Certification

    What is CE RED Certification? CE RED Certification is a crucial element within the European Union's regulatory landscape, intimately tied to the Radio Equipment Directive (RED) adopted on June 13, 2016. Its objectives include standardizing devices, ensuring efficient use of radio frequencies (rf), prioritizing user safety, and guarding against data theft and fraud. The RED directive serves as the foundation for additional standards covering various aspects: emergency services calling; equipment compatibility; privacy protection; corporate secrecy; crime prevention; ensuring confidential communications of intelligence services. The Importance of the Radio Equipment Directive RED certification opens the door to selling equipment in all 27 countries of the European Union, the third-largest electronics market by revenue globally. Additionally, many countries, including Australia and those in the Middle East and North Africa (MENA), have adopted the CE RED standard as their national regulation. What Products Need the RED Mark? All radio frequency emitting sources sold in the EU undergo RED testing. Unlike the previous R&TTE standard, the new directive does not impose any limits on device frequency range or supply voltage. Commonly certified equipment includes: smartphones and cell phones; radio frequency identifiers (RFID); common band transmitters (CB); stationary and mobile satellite systems; wireless networking equipment; stationary wireless telephones; industrial, scientific, and medical standard (ISM) transmitters; avionics; navigation systems; telemetry for remote control of equipment; wireless headphones and microphones, etc. What Products Can Be Sold Without the RED Mark? The RED directive does not apply to amateur communication devices like pre-tuned Walkie-Talkies for short-distance communication. Exceptions also include equipment used by the military, police, and national security services. For example, aircraft communications and navigation systems follow a separate standard (EC216/2008), and shipboard radio equipment adheres to EN 60945. How to Apply for RED Certification? Manufacturers can bring a product to market through certification for conformity to harmonized EU standards, CE RED testing under authorized bodies, or notification of a certified quality system. The certification process involves preparing technical documentation, conducting tests, and issuing a Declaration of Conformity. How to Get RED Certification? RED testing confirms product compliance with EU regulations for the effective and safe use of radio frequencies. Manufacturers must provide : technical documentation, including a description of the appearance, functions, interface, and software of the device; a copy of the Declaration of Conformity; if possible, a copy of the Certificate of Conformity to EU standards; instructions for use, including accessories and software. The certification procedure typically takes 4 to 8 weeks. For complex products, which must conform to a large number of regulations, the time frame extends to 8 to 12 weeks.  Manufacturer's Responsibility Companies seeking RED certification must certify their product for use in at least one EU country and submit technical documentation. Responsibilities include applying CE marking, publishing geographical limitations, maintaining complaint registers, and recalling non-compliant products. Distributor Responsibility Authorized companies selling equipment in the EU must ensure products meet RED standards. Altering technical characteristics is forbidden, and doubts about CE RED compliance require suspension of sales and withdrawal of supplied equipment. Differences Between RED and FCC Certificates CE RED and FCC Certificates are regulatory approvals for electronic devices in the EU and the United States, respectively. CE RED emphasizes safety without frequency limits, addressing intentional emitters with a comprehensive assessment. In contrast, FCC certification is mandatory for United States radio equipment and has less stringent overall requirements but enforces rigorous testing exclusively by accredited laboratories. Manufacturers need to grasp these distinctions for compliance in their target markets. Easy CE RED Certification with 360Compliance 360Compliance facilitates bringing electronic products to the European Union, Australia, and other markets. Offering a full range of services related to CE RED certification, including drawing up work plans and obtaining documents, the company ensures transparent prices, clear service timelines, and full technical support at all stages of the procedure. Apply online to learn more about RED certification.

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    Why is CE Certification Important?

    CE certification confirms that the product entered the market legally, has all the permits, and does not pose any threat to human health or the safety and integrity of the environment. Thus, the CE mark signals both buyers and official regulators about the successful completion of all testing and certifying procedures.

    What Countries Require CE Compliance?

    The mandatory CE certification applies to products entering the market of all 30 countries of the European Economic Area (EEA). It also covers Switzerland and Turkey, the United Kingdom, which have signed a number of bilateral agreements with the EU, including the CE marking requirement. Additionally, the UK indefinitely recognizes the EU’s CE mark for various manufactured goods placed on the UK market.

    European Economic Area Countries

    Other Countries

    Austria Denmark Hungary Lithuania Portugal Switzerland
    Belgium Estonia Iceland Luxembourg Romania Turkey
    Bulgaria Finland Ireland Malta Slovakia UK
    Croatia France Italy Netherlands Slovenia  
    Republic of Cyprus Germany Latvia Norway Spain  
    Czech Republic Greece Liechtenstein Poland Sweden  

    Which Products Need a CE Mark?

    To determine whether a product requires CE certification, manufacturers should consult the relevant EU directives and harmonized standards. Notified bodies, independent organizations authorized to assess product compliance with EU directives, can also provide guidance.

    Product Category Examples
    Electrical equipment Household appliances, power tools, lighting, cables
    Toys Dolls, action figures, toy cars, construction sets
    Machinery Industrial machinery, agricultural machinery, construction machinery
    Medical devices Surgical instruments, implants, diagnostic equipment
    Construction products Cement, steel, windows, doors
    Personal protective equipment Safety helmets, goggles, gloves, boots
    Pressure equipment Gas cylinders, boilers, pressure cookers
    Gas appliances Cookers,  heaters, gas water heaters
    Aerosols Spray paint, deodorants, insecticides
    Telecommunications equipment Mobile phones, routers, modems
    Radio equipment Radios, televisions, Bluetooth devices
    Lifts Escalators, elevators, dumbwaiters
    Explosive devices Fireworks, detonators, ammunition

    Products That May Be Sold Without a CE Mark

    Not all products imported into the listed countries require CE marking certification. In particular, goods belonging to the following categories, which are covered by other Directives, are subject to a different type of certification:

    • Chemical products
    • Cosmetics
    • Food products
    • Pharmaceuticals

    How to Obtain CE Certification?

    Obtaining a CE certificate involves a systematic process:

    Identify Applicable Directives

    The Directives include general safety requirements for products placed on the market. The specific parameters and technical requirements are detailed in the harmonized standards. If a product does not fall under any Directives requiring CE marking, it must still comply with a document outlining general safety requirements.

    Directive Number Product Category
    2014/35/EU Low Voltage Directive (LVD)
    2014/30/EU Electromagnetic Compatibility (EMC)
    2014/29/EU Simple Pressure Vessels Directive
    2009/125/EC Ecodesign for Energy-related Products
    2000/14/EC Noise Emission for Outdoor Equipment
    2009/48/EC Toy Safety
    Regulation (EU) No 305/2011 Construction Products
    2006/42/EC Machinery
    Regulation (EU) 2016/425 Personal Protective Equipment
    2014/31/EU Non-automatic Weighing Instruments
    Regulation (EU) 2016/426 Appliances Burning Gaseous Fuels
    2014/28/EU Explosives for Civil Uses
    Regulation (EU) 2017/745 Medical Devices
    90/385/EEC Active Implantable Medical Devices
    98/79/EC In Vitro Diagnostic Medical Devices
    2014/34/EU Equipment and Protective Systems for Use in Explosive Atmospheres (ATEX)
    2014/90/EU Marine Equipment Directive
    2013/53/EU Recreational Craft
    2014/33/EU Lifts
    2014/68/EU Pressure Equipment
    2014/53/EU Radio Equipment
    Regulation (EU) 2016/424 Cableway Installations to Carry Persons
    2014/32/EU Measuring Instruments
    2013/29/EU Pyrotechnic Articles
    2011/65/EU Restriction of Hazardous Substances (RoHS)

    Identify the requirements for the product

    Each Directive specifies essential requirements that a product must meet. To demonstrate conformity, manufacturers must identify applicable ‘harmonized European Norms’ (hENs), which are standards that offer a presumption of conformity to the essential requirements. These standards vary depending on the product’s classification and intended use. Harmonized standards, available on the European Commission’s website, simplify compliance through clear frameworks.

    Determine if third-party assessment is needed

    Certain directives may require third-party assessment by a Notified Body (NB), an organization authorized by European authorities. For example, the Medical Devices directive and others mandate the use of an NB. However, the EU has reduced the number of products requiring NB assessment, placing more responsibility on manufacturers.

    Assess Product Conformity

    Conduct a thorough assessment of your product to ensure it conforms to the essential requirements outlined in the relevant directives. This step may involve testing and verification processes to demonstrate that your product meets the necessary safety and environmental standards.

    Compile a Technical File

    Create a comprehensive technical file that documents every aspect of your product’s design, development, and manufacturing process. This technical file, also known as the Technical Construction File, should include technical descriptions, drawings, circuit diagrams, bills of materials, specifications, test reports, and other relevant information. The file serves as evidence of conformity and must be maintained for up to 10 years after the last unit is manufactured.

    MAKE A DECLARATION AND AFFIX THE CE MARK

    When satisfied that the product conforms to the applicable CE Marking Directives, the manufacturer must complete a Declaration of Conformity. It includes information about the product, directives, standards applied, and the responsible party in the company. 

    Following this, affix the CE mark visibly on the product, signaling compliance with EU standards. This is the final stage, after which the product may be launched to the EU and EEA markets.

    Responsibility of Manufacturers for CE Certification

    To complete the standard procedure for obtaining the CE mark, manufacturers must find out which EU Directive regulates the access of products of their category to the market and check compliance with all regulations. After that, a conformity assessment is carried out, based on which a technical file is prepared. Further, the EU-authorized body examines the documents, and the manufacturer issues the EC Declaration of Conformity (DoC). When all documents are certified and the CE mark is received, the manufacturer can label with this mark their products and packaging.

    Responsibility of Distributors for Products with a CE Mark

    Distributors of goods in the EU market must ensure that the CE mark has not yet expired and that the certificate itself is not fake. They also check the placement of the stamp on the product or its packaging since marking is the responsibility of the manufacturer.

    What is the Advantage of CE Certification?

    There are several advantages to CE certification, including:

    • Free movement of goods within the EEA

    Allows manufacturers to freely circulate their products within the EEA without facing additional technical barriers to trade.

    • Increased market access

    CE certification can help manufacturers gain access to new markets in the EEA, as well as in other countries that recognize the CE marking.

    • Enhanced product safety

    Helps to ensure that products meet high standards of safety and environmental protection.

    • Improved consumer confidence

    CE certification indicates independent compliance with EU safety requirements, boosting consumer confidence.

    Become CE Certified with 360Compliance

    The CE marking procedure can be tedious and incomprehensible to non-professionals. However, the 360Compliance team will help you pass all stages of certification quickly, competently, and successfully. You will receive full project management with no hassle. You are also guaranteed technical support and a transparent pricing policy.

    To start the testing & certification process for obtaining a CE stamp, contact the 360Compliance team in any convenient way and get all the answers and instantly initiate the certification procedure.

    Frequently Asked Questions About CE Marking

    For How Long is a CE Certificate Valid?

    For each product group, a certain validity period is established, but in most cases, it is 3 years. After that, you need to go through the re-certification procedure. However, there are products for which the CE mark is valid for 10 years or more.

    What are the Penalties for the Absence of a CE Certificate?

    Punishment for selling goods without the certificates in countries where the CE marking is mandatory varies widely from administrative to criminal liability. The specific article of the law that will be applied depends on the damage that a given product can cause to people or the environment.

    How to Get a CE Certificate?

    To obtain the CE stamp, it is necessary to go through a risk assessment procedure for the products offered. For this, you need to study the standards of the specific Directive that regulates access to the market for this type of products, make up a technical file, and pass testing. When all permits are issued, CE marking can be applied to the offered products.

    How to Authenticate a CE Certificate?

    You can authenticate a CE mark using the official database. Also, it is possible to contact the official authority that issued the certificate and request details on this product. If it turns out that this product is not registered with official institutions, you are dealing with fake certification.

    Other Certifications

    CE EMC Certification

    What is CE EMC Certification? CE EMC Certification is a mark that indicates a product's compliance with Electromagnetic Compatibility (EMC) requirements in the European Union. EMC is crucial because electronic devices emit electromagnetic waves during operation, and without proper EMC measures, these emissions can lead to Electromagnetic Interference (EMI). The CE mark, which stands for Conformité Européenne, is a mandatory certification for products sold within the European Economic Area (EEA). It signifies that a product meets the essential EMC standards set by the European Union to ensure that it won't cause or be susceptible to electromagnetic interference. This interference could affect the proper functioning of other nearby electronic devices. The certification process is guided by Directive 2014/30/EU, which outlines the specific EMC requirements that products must meet to obtain the CE mark. This directive establishes the legal framework for electromagnetic compatibility and mandates that manufacturers thoroughly test their products for compliance. The goal is to guarantee that electronic devices can coexist harmoniously in the European market without causing disruption or compromise in functionality. Which Products Need the CE EMC Mark? If your product falls into the category of devices that can emit electromagnetic waves during operation, it likely requires the CE EMC mark. Here are some examples of products that typically need this certification: Electrical Appliances: Household appliances such as washing machines, refrigerators, and microwave. Information Technology Equipment: Computers, laptops, servers, and networking equipment. Consumer Electronics: This includes a broad range of devices like televisions, audio equipment, and gaming consoles.  Medical Devices: Equipment used in the medical field, such as diagnostic machines and monitoring devices. Telecommunications Equipment: Phones, routers, and other communication devices. Industrial Machinery: Various types of machinery used in industrial settings, like manufacturing equipment and automation systems. Lighting Products: From simple light bulbs to complex lighting systems. Electronic Toys: Children's toys that incorporate electronic components or emit electromagnetic signals during play. Why is EMC CE Testing Important? Ensuring Market Access: Legal Compliance: CE EMC Certification is a legal requirement for placing products in the EU market. Non-compliance can result in serious consequences, including fines and withdrawal of products from the market. Enhanced Market Credibility: Products with CE EMC Certification signal adherence to high-quality standards, enhancing your brand's credibility and customer trust. Quality Assurance: Product Reliability: EMC Certification ensures that your products can function in the presence of electromagnetic disturbances, making them more reliable. Reduced Interference: Certification reduces the risk of your products causing interference with other electronic devices, preventing potential issues for end-users. How to Get CE EMC Certification? Step-by-Step Guidance: Consultation: Initiate the process with a consultation to understand your product and specific certification needs. Pre-assessment: Identify potential EMC issues and address them before formal testing to expedite the certification process. Testing and Evaluation: Utilize our accredited laboratories for comprehensive emissions and immunity testing. Documentation Support: Our team assists in preparing the necessary technical documentation required for certification. Declaration of Conformity: Once certified, we help you issue the Declaration of Conformity and affix the CE mark to your product. How long will testing take? The EMC CE certification procedure takes 4 to 6 weeks on average. If the product belongs to an industry that is regulated by other directives (e.g. CE RED), it is subject to additional tests, which increases the time required. Manufacturer's Responsibilities Related to EMC CE Certification The company that develops a product shall design it according to EMC CE norms and confirm compliance with the norms by independent laboratory tests. It is also required to: indicate the actual electromagnetic radiation level in the documentation; warn about the possible hazards associated with the use of the device; provide the user with operating instructions; indicate geographical restrictions on the use of the product, if any; keep a register of complaints; store certificates and declarations of conformity for at least 10 years; cooperate with local authorities and provide product samples to the authorities. Quick and Easy EMC CE Certification with 360Compliance Obtaining CE EMC Certification is not just a regulatory obligation; it is a strategic move to ensure your products' quality, compliance, and market competitiveness. By investing in certification, your business can access new markets, build trust with customers, and stay ahead in the dynamic world of electronics. At 360Compliance, we simplify the process, offering expert guidance and tailored solutions to ensure your products meet the highest standards of electromagnetic compatibility. Contact us to get transparent pricing, clear timelines, and technical support at all stages of the procedure.

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    CE Certification For Medical Devices

    What is CE MD Certification? CE MD certification is a mandatory requirement for all medical devices that are sold in the European Union. The CE mark is a symbol that indicates that a product has met all of the applicable EU directives and regulations. To obtain CE marking for medical devices, manufacturers must adhere to the regulatory framework outlined in the Medical Devices Regulation (MDR) or the In Vitro Diagnostic Regulation (IVDR). The primary objective of CE approval for medical devices is to ensure the safety, effectiveness, and alignment with the needs of patients and healthcare professionals. The process is regulated by EU Directive 2017/745 and relevant industry regulations, including 90/385/EEC, 93/42/EEC, 98/79/EC, and 722/2012. Which Products Require MDR CE Marking? CE MD marking is mandatory for a wide range of medical devices, including but not limited to: Diagnostic Equipment; Implants; Surgical Instruments; Monitoring Devices; Dental Products; Rehabilitation Equipment. Manufacturers must ensure their products align with specific classifications and requirements outlined in the applicable directives. Which products do not need the CE MD Mark? CE medical device certification is unnecessary if the product does not meet the definition of a medical device outlined in EU Directive 2017/745 (MDR). In that case, other industry regulations, like those governing radio frequency or electromagnetic radiation, are applicable. Additionally, products can be sold without a CE certificate if alternative standards have been set for them, as seen with medicines, food products, cosmetics, and chemicals. CE Certification Process for Medical Devices The CE certification process for medical devices involves several key steps: Legal Requirement CE marking is mandatory for medical devices under the EU Medical Devices Regulation (MDR) or the In Vitro Diagnostic Medical Devices Regulation (IVDR), depending on the nature of the product. Conformity Assessment To obtain CE marking, manufacturers must undergo a conformity assessment, which involves demonstrating that the medical device complies with the relevant essential requirements and standards. Particularly the IEC 60601 series, which specifically addresses the safety and essential performance of medical electrical equipment. Classification of Devices Classifying devices involves categorizing medical devices into different classes based on their risk level. The classification determines the conformity assessment procedure that the manufacturer must follow. Technical Documentation Manufacturers must create and maintain technical documentation supporting the conformity of the medical device. This documentation should cover aspects such as design, manufacturing, risk assessment, and labeling. Notified Bodies In many cases, a Notified Body, an independent third-party organization, is involved in the conformity assessment process. The Notified Body assesses the technical documentation and issues a certificate if the requirements are met. Post-Market Surveillance CE marking is not a one-time event. Manufacturers must continue to monitor their products after they enter the market. Post-market surveillance involves tracking the device's performance, addressing any safety concerns, and updating documentation as needed. Unique Device Identification (UDI) The EU MDR and IVDR require the use of a Unique Device Identification system, allowing for traceability and improved post-market surveillance. The timeframe for issuing the certificate varies depending on the niche and the application of the device. The average time for a Class A device is 4 to 8 weeks. Clinical testing of Class B and C devices can take several months. Benefits of CE Certification for Medical Devices Market Access Achieving CE certification opens the doors to the vast European market, allowing manufacturers to distribute and sell their medical devices within the EU. Compliance with Regulations CE certification ensures that your medical device complies with the stringent regulations and standards set by the European authorities, fostering trust among healthcare professionals and end-users. Enhanced Reputation Displaying the CE mark on your medical devices demonstrates a commitment to quality and safety, enhancing your brand's reputation in the competitive healthcare industry. Risk Mitigation Compliance with CE mark medical device requirements helps mitigate legal and financial risks associated with non-compliance, ensuring that your products meet the highest safety and performance standards. Quick CE MD Certification with 360Compliance We provide a full range of CE certification services for medical devices. Our employees provide assistance with all the stages of this procedure from evaluating the legal environment and determining the class of equipment to the paperwork and cooperation with authorized bodies. We guarantee transparent prices, clear deadlines, and convenient technical support. Get your certificate quickly and with a minimum of effort by leaving an application on our website to learn more about our services!

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    CE RED Certification

    What is CE RED Certification? CE RED Certification is a crucial element within the European Union's regulatory landscape, intimately tied to the Radio Equipment Directive (RED) adopted on June 13, 2016. Its objectives include standardizing devices, ensuring efficient use of radio frequencies (rf), prioritizing user safety, and guarding against data theft and fraud. The RED directive serves as the foundation for additional standards covering various aspects: emergency services calling; equipment compatibility; privacy protection; corporate secrecy; crime prevention; ensuring confidential communications of intelligence services. The Importance of the Radio Equipment Directive RED certification opens the door to selling equipment in all 27 countries of the European Union, the third-largest electronics market by revenue globally. Additionally, many countries, including Australia and those in the Middle East and North Africa (MENA), have adopted the CE RED standard as their national regulation. What Products Need the RED Mark? All radio frequency emitting sources sold in the EU undergo RED testing. Unlike the previous R&TTE standard, the new directive does not impose any limits on device frequency range or supply voltage. Commonly certified equipment includes: smartphones and cell phones; radio frequency identifiers (RFID); common band transmitters (CB); stationary and mobile satellite systems; wireless networking equipment; stationary wireless telephones; industrial, scientific, and medical standard (ISM) transmitters; avionics; navigation systems; telemetry for remote control of equipment; wireless headphones and microphones, etc. What Products Can Be Sold Without the RED Mark? The RED directive does not apply to amateur communication devices like pre-tuned Walkie-Talkies for short-distance communication. Exceptions also include equipment used by the military, police, and national security services. For example, aircraft communications and navigation systems follow a separate standard (EC216/2008), and shipboard radio equipment adheres to EN 60945. How to Apply for RED Certification? Manufacturers can bring a product to market through certification for conformity to harmonized EU standards, CE RED testing under authorized bodies, or notification of a certified quality system. The certification process involves preparing technical documentation, conducting tests, and issuing a Declaration of Conformity. How to Get RED Certification? RED testing confirms product compliance with EU regulations for the effective and safe use of radio frequencies. Manufacturers must provide : technical documentation, including a description of the appearance, functions, interface, and software of the device; a copy of the Declaration of Conformity; if possible, a copy of the Certificate of Conformity to EU standards; instructions for use, including accessories and software. The certification procedure typically takes 4 to 8 weeks. For complex products, which must conform to a large number of regulations, the time frame extends to 8 to 12 weeks.  Manufacturer's Responsibility Companies seeking RED certification must certify their product for use in at least one EU country and submit technical documentation. Responsibilities include applying CE marking, publishing geographical limitations, maintaining complaint registers, and recalling non-compliant products. Distributor Responsibility Authorized companies selling equipment in the EU must ensure products meet RED standards. Altering technical characteristics is forbidden, and doubts about CE RED compliance require suspension of sales and withdrawal of supplied equipment. Differences Between RED and FCC Certificates CE RED and FCC Certificates are regulatory approvals for electronic devices in the EU and the United States, respectively. CE RED emphasizes safety without frequency limits, addressing intentional emitters with a comprehensive assessment. In contrast, FCC certification is mandatory for United States radio equipment and has less stringent overall requirements but enforces rigorous testing exclusively by accredited laboratories. Manufacturers need to grasp these distinctions for compliance in their target markets. Easy CE RED Certification with 360Compliance 360Compliance facilitates bringing electronic products to the European Union, Australia, and other markets. Offering a full range of services related to CE RED certification, including drawing up work plans and obtaining documents, the company ensures transparent prices, clear service timelines, and full technical support at all stages of the procedure. Apply online to learn more about RED certification.

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