Are you developing smart, connected devices and want to ensure they meet global cybersecurity standards? Concerned about the rising expectations for digital security across international markets? Navigating the world of cybersecurity testing can feel overwhelming, especially with evolving regulations. At 360Compliance, we simplify the process, ensuring your products align with essential cybersecurity requirements for seamless global market access.
What Is Cybersecurity Testing?
Cybersecurity testing ensures that products with digital components, such as IoT devices, software applications, and connected solutions, comply with cybersecurity regulations and best practices. The testing evaluates your product’s security features to identify and address potential vulnerabilities, ensuring that your device or software is protected against unauthorized access, data breaches, and cyberattacks.
Cybersecurity testing not only ensures regulatory compliance but also strengthens consumer trust and protects your brand’s reputation in today’s highly interconnected world.
EN 303 645 Compliance | IoT Cybersecurity Testing
EN 303 645 is the leading European cybersecurity standard for consumer IoT devices, providing manufacturers with a clear framework to reduce cyber risks and meet regulatory requirements. For companies developing smart products, achieving EN 303 645 compliance not only ensures device security but also builds customer trust, supports CE/UKCA marking, and opens access to global markets. At 360Compliance, we help manufacturers navigate the testing and certification process so their IoT products are safe, compliant, and ready for worldwide distribution. What is ETSI EN 303 645? EN 303 645 is the European cybersecurity standard for consumer IoT devices, created by ETSI to set baseline security requirements. It tackles common risks such as weak passwords, insecure updates, and poor data protection. For manufacturers, EN 303 645 compliance shows that connected products follow recognized cybersecurity best practices, helping to protect users, build trust, and support CE/UKCA approvals. 👉 For the complete technical specification, see the official ETSI EN 303 645 standard (PDF). Key areas covered by EN 303 645 include: Removing universal default passwords Providing secure software and firmware updates Protecting personal and sensitive data Enforcing strong authentication and access control Establishing clear vulnerability disclosure policies Why Do You Need ETSI EN 303 645 Compliance? For manufacturers of connected products, ETSI EN 303 645 compliance is more than just a technical requirement—it’s a competitive advantage. This standard helps ensure your IoT devices are secure, trusted, and accepted in global markets. Meeting EN 303 645 shows regulators, partners, and customers that your products follow best-practice cybersecurity principles. It also supports related EU frameworks such as the Cyber Resilience Act (CRA) and complements CE RED cybersecurity testing solutions, making it a cornerstone of your compliance strategy. Which Products Need to Comply? This framework applies to a wide range of consumer IoT devices, including but not limited to: Smart home devices (thermostats, security cameras, door locks) Wearables (smart watches, fitness trackers) Connected appliances (refrigerators, washing machines) Home entertainment systems (smart TVs, speakers) IoT gateways and hubs As IoT technology advances, more devices are being integrated into homes and workplaces. Ensuring compliance with these standards not only secures these devices but also protects consumers from cyber threats. 👉 If you are developing smart or connected products, our cybersecurity testing services ensure your devices meet the latest requirements for global market access. Steps to Achieve IoT Device Compliance To achieve compliance, manufacturers need to follow several critical steps. Guidance from experts can help you through the process, providing consultation and project management: Assessment of IoT Device Security – Conduct a thorough review of your product’s cybersecurity features to identify any vulnerabilities. Implementation of Security Measures – Ensure your product meets all 13 baseline provisions. Security Testing – Perform rigorous testing to verify that your IoT devices are secure and resistant to attacks. Documentation and Reporting – Prepare all necessary documentation, including a vulnerability disclosure policy, to demonstrate compliance. Certification – Obtain certification, ensuring your IoT devices meet the required cybersecurity standards. Consequences of Non-Compliance Failure to comply can result in significant consequences, including: Product Vulnerabilities – Non-compliant devices are more susceptible to cyberattacks, which can lead to data breaches, device hijacking, or other malicious activities. Market Access – Non-compliance may limit your access to key markets, particularly in the European Union where cybersecurity regulations are stringent. Reputational Damage – A security breach can cause long-lasting harm to your brand's reputation, resulting in loss of consumer trust and market share. Frequently Asked Questions Is ETSI EN 303 645 mandatory for IoT devices in the EU? While the standard is not legally mandatory, it is considered the benchmark for cybersecurity in the IoT industry. Manufacturers who comply are better positioned in the EU market and face fewer risks from vulnerabilities. Which organizations need to comply with ETSI EN 303 645? Any company that manufactures, imports, or sells consumer IoT devices in Europe should follow these standards to ensure their products meet the latest security requirements. Does ETSI EN 303 645 apply to business IoT devices? The standard is primarily aimed at consumer IoT devices. However, manufacturers of enterprise IoT solutions may also benefit from implementing its provisions to enhance device security and reduce cyber risks. Why Choose 360Compliance for ETSI EN 303 645 Certification? Navigating the complexities of IoT cybersecurity can be challenging. At 360Compliance, we provide expert guidance and support to ensure your IoT devices meet ETSI EN 303 645 standards. Our services include: End-to-End Project Management – From initial assessment to final certification, we manage the entire process for you. Expert Security Testing – We conduct comprehensive testing to ensure your products meet all security requirements. Global Market Access – By complying with ETSI EN 303 645, your products will be ready for the European market and beyond. Fixed Pricing – We offer transparent pricing with no hidden fees, helping you stay within budget while achieving compliance. Secure your IoT devices and build consumer trust by partnering with 360Compliance for ETSI EN 303 645 certification. Contact us today to get started on the path to compliance and global market success.
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Cyber Resilience Act
As our world becomes increasingly digital, the cybersecurity of connected products is more crucial than ever. The Cyber Resilience Act (CRA) is an essential piece of legislation proposed by the European Union, designed to ensure that hardware and software products sold in the EU meet stringent cybersecurity requirements. In light of growing risks from cyberattacks, this act aims to protect both consumers and businesses by embedding security into the design, development, and lifecycle of digital products. Discover how compliance with the Cyber Resilience Act can safeguard your digital devices and open doors to the European market. What is the Cyber Resilience Act? The EU proposed the Cyber Resilience Act to enhance the cybersecurity of products with digital components. Specifically, It establishes essential cybersecurity standards that manufacturers, developers, and distributors must meet to ensure the security of their digital products across their entire lifecycle. The Act targets various aspects of cybersecurity, including: Security by design – Ensuring that cybersecurity is integrated from the earliest stages of product development. Continuous updates and vulnerability management – Requiring manufacturers to ensure regular software updates and vulnerability patching. Transparency and accountability – Mandating that companies disclose security risks and provide clear instructions for secure use. Complying with the act will not only protect users from cyber threats but also offer companies a competitive advantage in the security-conscious market. Why is Compliance Important for Digital Products? The CRA will revolutionize how manufacturers and developers approach the security of their digital products. By complying, you protect your products from cyberattacks, which in turn reduces the risk of costly data breaches, loss of consumer trust, and regulatory penalties. Additionally, aligning your products with the Cyber Resilience Act will help you gain entry to the EU market and demonstrate a commitment to high cybersecurity standards—key for companies looking to expand globally. Which Products Will be Impacted? The Cyber Resilience Act applies to a wide range of digital products, including: Connected devices (IoT products, smart appliances, wearables) Software applications (operating systems, mobile apps, desktop software) Hardware with digital elements (smart home devices, industrial IoT) Cloud services and related platforms The Cyber Resilience Act will impact any product with digital elements that connects to other devices or networks. As the digital landscape continues to grow, ensuring compliance with the CRA will become increasingly important for businesses. How to Achieve Compliance with Cybersecurity Standards To comply with the new rules, companies need to take several steps to ensure their digital products meet the latest cybersecurity requirements: Assess Cybersecurity Risks – Perform a thorough risk assessment to identify potential security vulnerabilities in your digital products. Implement Security by Design – Integrate robust security features into your product during the design phase. Continuous Security Monitoring – Establish mechanisms to monitor and patch vulnerabilities throughout the product lifecycle. Documentation and Reporting – Maintain comprehensive documentation to demonstrate compliance with the CRA’s requirements. Obtain Certification – Ensure your product complies with the necessary standards and obtain certification to access the European market. Consequences of Non-Compliance Failing to meet the cybersecurity standards can lead to serious consequences, such as: Market Access Limitations – Non-compliant products may be restricted from entering the EU market. Fines and Penalties – Companies that fail to meet the CRA's requirements may face financial penalties. Reputational Damage – A breach in cybersecurity due to non-compliance can lead to significant reputational harm, resulting in the loss of consumer trust and business opportunities. Frequently Asked Questions about the Cyber Resilience Act Is the Cyber Resilience Act mandatory for all digital products in the EU?Yes, the Cyber Resilience Act will require manufacturers, developers, and distributors of products with digital elements to comply with its cybersecurity standards to sell their products in the EU. Which industries will be most affected by the Cyber Resilience Act?The CRA will primarily impact industries producing IoT devices, consumer electronics, software, and industrial systems that rely on connected digital elements. How long will companies have to comply with the Cyber Resilience Act?After the Act takes effect, companies will likely have a transition period to align their products with the new cybersecurity regulations. Why Cybersecurity Matters Now More Than Ever With cyberattacks on the rise, the Cyber Resilience Act is a timely and necessary step toward ensuring that digital products are secure by design. The Act will significantly reduce vulnerabilities, create a safer digital ecosystem, and foster consumer trust in technology. By complying with the CRA, your business can secure its digital products and gain a competitive edge in the European and global markets. Why Choose 360Compliance for Cyber Resilience Act Certification? Navigating the complexities of the CRA can be challenging. 360Compliance provides expert guidance and support to help your company achieve full compliance with the CRA. Our services include: End-to-End Project Management – From risk assessments to certification, we handle the entire process for you. Expert Cybersecurity Consultation – Our team of specialists will help you implement security by design and meet CRA requirements. Global Market Access – Achieving compliance with the CRA ensures that your products are ready for the European market and beyond. By partnering with 360Compliance, you can streamline the certification process, secure your digital products, and maintain a competitive edge in the global market. Contact us today to get started on achieving Cyber Resilience Act compliance.
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UK PSTI Act
In today's increasingly connected world, ensuring the cybersecurity of smart devices is more critical than ever. The UK Product Security and Telecommunications Infrastructure (PSTI) Act aims to strengthen the security of consumer IoT devices by mandating strict cybersecurity standards. Introduced by the UK government, this legislation sets the bar for the safe production and distribution of connected devices, helping to protect consumers from cyber threats. Here’s what you need to know about the PSTI Act and how it impacts your business. What Is the UK PSTI Act? The UK PSTI law is a landmark regulation designed to secure smart devices sold in the UK. With the rise of the Internet of Things (IoT), the legislation addresses the vulnerabilities that connected devices can introduce. The act ensures that manufacturers follow best practices in device security, making products safer for consumers and preventing cyberattacks that exploit unsecured devices. Key security requirements include: Ban on default passwords: All devices must eliminate universal default passwords, which are a major cybersecurity risk. Vulnerability reporting: Manufacturers must provide a public point of contact to report security vulnerabilities, ensuring timely issue resolution. Clear labeling for consumers: Devices must inform users about the duration of security updates, helping them understand the product’s lifespan in terms of cybersecurity. Consequently, both manufacturers and consumers become fully aware of their security responsibilities related to connected devices. Why Is Compliance with the UK PSTI Act Important? The UK PSTI Act mandates compliance for all IoT devices sold in the UK, leaving no room for manufacturers and distributors to opt-out. By following these security standards, you protect your products from cyber threats and improve consumer trust. Additionally, failing to comply with the PSTI Act can result in fines, penalties, and restrictions on selling products in the UK. For that reason, failing to comply with the regulation can result in fines, penalties, and restrictions on selling products in the UK. Key benefits of compliance include: Enhanced security for connected devices Improved consumer trust and brand reputation Access to the UK market with fully compliant products As the use of connected devices continues to grow, maintaining high cybersecurity standards is crucial for the safety of consumers and the success of your business. Thus, staying compliant will secure your business operations in the long term. Which Products Are Covered by the UK PSTI Act? The PSTI Act applies to a broad range of connected devices, such as: Smartphones and tablets Smart home devices (thermostats, cameras, door locks) Wearables (smartwatches, fitness trackers) Gaming consoles and entertainment systems Smart appliances (refrigerators, washing machines, TVs) Routers and network infrastructure Any product that connects to the internet or another device must meet the security requirements outlined in the UK PSTI Act. How to Achieve Compliance with the UK PSTI Act Achieving compliance involves several key steps. Companies must ensure that the design, production, and marketing of their connected products meet these cybersecurity standards. Here’s how to comply with the PSTI Act: Eliminate Default Passwords: Ensure that your devices are not shipped with universal default passwords, which are often exploited by hackers. Create a Vulnerability Disclosure Policy: Establish a public point of contact for consumers to report vulnerabilities and address them in a timely manner. Maintain Security Updates: Inform consumers about the length of time that their device will receive security updates, ensuring transparency. Obtain Certification: Certify your product under UK regulations to demonstrate compliance and access the UK market. Following these steps will help ensure that your products are ready to meet the requirements, allowing you to confidently sell your devices in the UK. Consequences of Non-Compliance Non-compliance with the UK PSTI Act can lead to serious repercussions, including: Fines and Penalties: Companies that fail to meet standards may face financial penalties. Market Access Restrictions: Non-compliant products may be barred from sale in the UK, severely limiting your business opportunities. Reputational Damage: A cybersecurity breach can harm your brand's reputation, leading to loss of consumer trust and market share. Therefore, ensuring compliance not only helps avoid these risks but also positions your brand as a leader in cybersecurity and innovation. Frequently Asked Questions about the UK PSTI Is the UK PSTI Act mandatory for all IoT devices? Yes, the PSTI Act applies to all connected devices sold in the UK, including smartphones, wearables, smart appliances, and more. What are the penalties for non-compliance? Companies that fail to comply with the PSTI Act could face financial penalties and restrictions on selling their products in the UK. How long do companies have to comply with the PSTI Act? The act is already in place, so companies should ensure their products comply with the guidelines before entering the UK market. Why Choose 360Compliance for PSTI Certification? Navigating the requirements of the UK PSTI Act can be complex, but 360Compliance is here to help. We offer comprehensive services to ensure that your products meet the PSTI Act’s standards and are fully certified for sale in the UK. Our services include: Complete Project Management: From initial assessments to certification, we handle the entire compliance process, ensuring that your products are fully prepared for the UK market. Expert Consultation: Our team of specialists provides tailored advice on how to implement security measures that comply with the UK PSTI Act. Global Market Access: Beyond the UK, we help you achieve compliance with international standards, enabling you to access markets worldwide. Partner with 360Compliance to streamline your compliance process and secure your products for the UK market. Contact us today to get started on ensuring your products meet the UK PSTI Act requirements.
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CE RED Delegated Act
As technology advances, so do the risks associated with cybersecurity. The CE RED Delegated Act, a recent addition to the Radio Equipment Directive (RED), addresses the growing need for secure radio equipment by introducing strict cybersecurity requirements. This new regulation is vital for manufacturers aiming to sell radio equipment in the European Union, ensuring devices are protected from cyber threats. Learn how the new directive impacts your products and what you need to do to comply. What Is the CE RED Delegated Act? The CE RED Delegated Act is an extension of the Radio Equipment Directive that focuses on enhancing the cybersecurity of radio equipment sold within the European Union. Adopted by the European Commission, the act introduces additional cybersecurity requirements to ensure that devices are secure and that they protect users from unauthorized access, data breaches, and other cyber risks. The main purpose of this act is to: Ensure secure communication within radio devices Safeguard user privacy and personal data Prevent unauthorized access to devices and networks In light of increasing cyber threats, the CE RED Delegated Act is a critical regulation for ensuring that connected devices meet high security standards. Why Is the CE RED Delegated Act Important? The updated RED requirements have become essential in addressing cybersecurity issues in the growing Internet of Things (IoT) and connected device markets. With radio equipment playing a pivotal role in modern communication systems, any vulnerabilities could have serious consequences for users. Key benefits of compliance include: Enhanced security for devices, ensuring protection against unauthorized access and attacks Compliance with EU standards, allowing legal access to the European market Consumer trust in secure, safe products As a result, manufacturers must comply with these new requirements to ensure their products remain competitive and safe for consumers. Which Devices Must Comply with the New Requirements? The delegated regulation applies to a wide range of radio equipment, including: Mobile phones and smartphones Smart home devices Wearables such as smartwatches Wi-Fi routers Bluetooth devices IoT devices in general If your product uses radio frequencies to communicate, it must meet the new cybersecurity standards under the updated guidelines. Therefore, manufacturers should prioritize updating their products to meet these new regulations. Key Cybersecurity Requirements in the CE RED Delegated Act The new regulations introduce several key cybersecurity measures that manufacturers must adhere to. Specifically, these include: Secure Communication: Devices must ensure secure and encrypted communications to prevent interception and tampering. Protection of Personal Data: Devices must safeguard users' personal data and ensure that unauthorized access is prevented. Prevent Unauthorized Access: Measures must be in place to prevent unauthorized individuals from controlling or accessing devices. Regular Software Updates: Devices should be able to receive software updates to fix security vulnerabilities as they arise. By implementing these measures, manufacturers can ensure their devices comply with EU regulations and offer greater protection against cyber threats. Consequences of Non-Compliance with the CE RED Delegated Act Failing to comply with the new EU cybersecurity standards can lead to serious consequences, such as: Inability to sell products in the EU market Fines and penalties for non-compliance Reputational damage due to cybersecurity vulnerabilities Thus, manufacturers must prioritize compliance to avoid these risks and maintain market access in the EU. How to Achieve Compliance with the CE RED Delegated Act To comply with the new regulations, manufacturers must take the following steps: Conduct Risk Assessments: Evaluate potential cybersecurity risks in your devices and implement necessary security measures. Ensure Secure Communication: Integrate encrypted communication methods to protect data transmitted by your device. Implement Strong Data Protection: Ensure your device safeguards users' personal data and meets GDPR requirements. Provide Regular Software Updates: Establish a process for rolling out regular software updates to address vulnerabilities. Seek CE Marking Certification: Ensure your device is CE marked to verify compliance with the updated standards and gain access to the European market. Following these steps will help ensure your devices are compliant and ready for sale in the EU. Frequently Asked Questions What is the CE RED Delegated Act? The CE RED Delegated Act is a set of cybersecurity requirements added to the Radio Equipment Directive to ensure radio equipment sold in the EU is secure. Which products must comply with the new rules? All radio equipment, including smartphones, smart home devices, wearables, and IoT devices, must meet the cybersecurity standards under the CE RED Delegated Act. What happens if a company doesn’t comply with the new cybersecurity rules? Non-compliance can result in fines, penalties, and restrictions on selling products in the European Union. Why Choose 360Compliance for CE RED Delegated Act Certification? Navigating the complexities of the updated EU standards can be challenging, but 360Compliance offers expert guidance to ensure your products meet all necessary cybersecurity requirements. Our services include: Comprehensive Project Management: We handle the entire compliance process, from initial assessments to certification. Cybersecurity Expertise: Our team helps you implement the required security features to ensure compliance with the act. Global Market Access: With CE certification, your products can enter not only the EU market but also other international markets. Partner with 360Compliance to ensure your products meet the cybersecurity requirements of the updated regulations. Contact us today to get started.
Learn moreWhy Cybersecurity Testing Matters
As governments introduce new regulations to address emerging cyber threats, cybersecurity testing has become critical to ensure compliance and market access. Key regulations like the Cyber Resilience Act in the European Union aim to secure products by design throughout their entire lifecycle. Moreover, national frameworks such as the UK Product Security and Telecommunications Infrastructure (PSTI) Act ensure IoT devices meet specific security benchmarks to protect consumers.
Ensuring your products comply with cybersecurity standards like ETSI EN 303 645 is essential, especially for IoT devices entering European markets. Additionally, understanding the implications of directives such as the CE RED Delegated Act ensures your products meet all cybersecurity and radio-frequency safety requirements, keeping you ahead of regulatory challenges.
What Products Need Security Evaluations?
Cybersecurity testing is essential for a wide range of products, particularly those that connect to networks or store sensitive data. Some of the key product categories include:
- Internet of Things (IoT) devices: Smart home systems, wearables, industrial IoT sensors
- Mobile devices: Smartphones, tablets, and mobile terminals
- Software applications: Operating systems, cloud services, and mobile apps
- Telecommunications equipment: Gateways, routers, and connected communication hubs
- Consumer electronics: Smart TVs, connected appliances, and audio devices
Our Cybersecurity Testing Services
At 360Compliance, we understand the importance of cybersecurity and the complexity involved in meeting various regulations. Our cybersecurity testing services help you secure your products and ensure compliance with key regulations and frameworks. Here’s how we can assist:
1. Consultation and Gap Assessment
We analyze your product to identify potential security gaps and align it with relevant standards like ETSI EN 303 645 and UK PSTI requirements. Our expert consultants guide you through the necessary steps to strengthen your product’s cybersecurity.
2. Thorough Cybersecurity Testing
Using state-of-the-art testing methodologies, we perform security evaluations to identify potential vulnerabilities. We ensure that your product meets the standards set by regulations such as the Cyber Resilience Act and CE RED Delegated Act.
3. Regulatory Compliance Assistance
We help you navigate the complex landscape of cybersecurity regulations, ensuring your devices meet the necessary cybersecurity, radio-frequency, and operational safety requirements.
4. Custom Solutions for Market-Specific Needs
Whether your product targets the European, UK, or global market, we provide tailored solutions to meet regulatory demands. From ETSI EN 303 645 compliance to the CE RED Delegated Act, we ensure you’re ready for smooth market access.
The Benefits of Cybersecurity Testing with 360Compliance
- Expertise: Our specialists are well-versed in the latest cybersecurity regulations and testing methodologies.
- Efficiency: We streamline the certification process to save you time and resources while ensuring compliance.
- Market Access: Achieve certifications that open doors to global markets and reduce regulatory risks.
Ready to Secure Your Products?
Contact us today to ensure your products comply with the latest cybersecurity regulations and testing standards. Our experts will help you navigate the ever-changing regulatory landscape and secure your product’s future success.
Other Certifications
CE Certification
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 Marking? 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. What Products Need a CE Certification? 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 What Products Do Not Require a CE Marking? 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) 2011/65/EU Restriction of Hazardous Substances (RoHS) 2014/53/EU Radio Equipment 2014/34/EU Equipment and Protective Systems for Use in Explosive Atmospheres (ATEX) Regulation (EU) 2017/745 Medical Devices 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 90/385/EEC Active Implantable Medical Devices 98/79/EC In Vitro Diagnostic Medical Devices 2014/90/EU Marine Equipment Directive 2013/53/EU Recreational Craft 2014/33/EU Lifts 2014/68/EU Pressure Equipment Regulation (EU) 2016/424 Cableway Installations to Carry Persons 2014/32/EU Measuring Instruments 2013/29/EU Pyrotechnic Articles Full list of CE directives you can find here 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 conformity 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 Are the Benefits 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 EC 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 label is valid for 10 years or more. What are the Penalties for the Absence of a CE Compliance 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 label 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.
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EMC Directive 2014/30/EU
Do you manufacture or sell electrical or electronic equipment in the European Union (EU)? If so, you'll need to ensure your products comply with the Electromagnetic Compatibility (EMC) Directive 2014/30/EU. Wondering how you can streamline the compliance process to ensure your products meet the EU's stringent electromagnetic compatibility requirements? 360 Compliance is here to guide you through every step, ensuring your products not only comply but thrive in the European market. 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 Directive 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 Mark Medical Device
Do you manufacture or plan to sell medical devices in the European Union (EU)? If so, obtaining CE marking for medical devices is essential for legal market access. This signifies compliance with the Medical Devices Regulation (MDR) 2017/745. Looking for a partner to demystify the CE marking process and ensure your medical devices comply with EU regulations? At 360Compliance, we're here to provide guidance and support to address any questions you may have. 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 mark medical device? 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. Why Choose 360Compliance For CE Approval For Medical Devices? 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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