IA Search

Accessing the North American market FCC / ISED certification and NRTL trademarks Why certify your products for the North American market? The marketing of electrical and electronic equipment in North America (USA and Canada) requires compliance with strict regulations on electromagnetic compatibility (EMC), electrical safety and use of the radio frequency spectrum. These regulations are defined by bodies such as the Federal Communications Commission (FCC) in the United States and Innovation, Science and Economic Development Canada (ISED, formerly Industry Canada). Special requirements apply to medical devices (MDs).In addition, safety certifications are required by Nationally Recognized Testing Laboratories (NRTL) to guarantee the protection of users and infrastructures. Ask for a quote Our services for regulatory compliance in the United States and Canada We support manufacturers and exporters in their certification procedures with specialised services:FCC and/or ISED testing and certification for radio and digital equipment.Access to NRTL marks for electrical safety (UL, CSA, ETL...).Electromagnetic compatibility (EMC) and interference immunity testing.Compliance management for access to the North American market.Assistance in obtaining local and international certifications. FCC certification for the USA: A requirement for radio and electronic equipment Determining the applicable FCC rules Identification of technical and administrative requirements according to product type.Application of FCC Part 15, Part 18 and other relevant regulations. Selecting the approval procedure FCC Certification: Required for radio transmitting equipment (Wi-Fi, Bluetooth, cellular, etc.).Supplier's Declaration of Conformity (SDoC): Applicable to digital equipment without a radio module. Carrying out FCC compliance tests Tests in one of our FCC-accredited laboratories to verify RF and EMC emission levels.Verification of RF exposure limits for portable devices. FCC approval obtained Submission of the file to a Telecommunication Certification Body (TCB) for certification.Award of an FCC ID allowing the product to be marketed in the United States.FCC marking applied to the product and mandatory information included in the user documentation. Talk to our experts in CE marking, UKCA and UKNI Contact us ISED requirements for the Canadian market ISED certification and radio approval Allocation of an IC certification number for RF equipment.Application of Canadian standards equivalent to FCC requirements. EMC and ICES compliance Compliance with ICES standards for electromagnetic compatibility.Compulsory marking and instructions in English and French. Harmonisation between FCC and ISED Mutual recognition of tests between the two authorities.Requirements specific to each market (labelling, bilingual documentation, etc.). Electrical equipment safety: NRTL certifications Unlike Europe (CE marking), there is no single government mark for electrical safety in North America. Instead, independent laboratories (called NRTL, recognised by OSHA) certify that a product is safe according to the applicable UL/CSA standards. The product will then bear a safety mark such as UL, CSA or ETL, recognised by the American and Canadian authorities.This certification is essential for installing equipment in many contexts (commercial buildings, factories) and is highly recommended for all electrical products sold to the general public, as it engages the manufacturer's liability in the event of a safety defect. Why choose the expertise of the Emitech Group? Our experts can help you simplify and optimise your certification process:Identification of regulatory requirements specific to your product.Planning and carrying out FCC, ISED and NRTL tests.Optimising certification processes to reduce lead times and costs.Documentary support and marking in compliance with North American regulations.We offer you support from the very start of your projects. We work with you to identify the requirements for your different markets. In response, we draw up a marketing strategy with you, recommending the steps to be taken, the documentary analyses to be carried out and the envelope of tests to be carried out in order to optimise your costs and timescales. Contact us for a quote Do you need fast, efficient certification for your products in the United States and Canada? Contact our experts for a tailored solution. Request a quote now

CB SCHEME: INTERNATIONAL CERTIFICATION FOR YOUR ELECTRICAL AND ELECTRONIC PRODUCTS The international passport for your electrical equipment Why use the CB scheme? The IECEE CB Scheme is an international system that gives manufacturers of electrical and electronic equipment easier access to world markets by simplifying the procedures for obtaining national marks.The scheme offers : Mutual recognition of conformity tests in over 50 countries, reducing certification times and costs.Simplification of regulatory procedures, avoiding duplication of tests for each target market.Guaranteed compliance with IEC and CISPR standards, while taking account of specific national requirements.Rapid access to local certification marks, using recognised laboratories and certification bodies.Reduce costs and optimise resources, by reducing the number of tests required and improving the efficiency of the time-to-market process. Ask for a quote Our CB Scheme certification services We support manufacturers and exporters in managing their international certification processes through our specialist services:Identification of applicable IEC and CISPR standards and required national deviations.Carrying out tests in approved laboratories (CBTL).Issuance of CB Test Certificates via a National Certification Body (NCB).Assistance in obtaining additional local certification.Document management and regulatory monitoring to ensure ongoing compliance. How the CB scheme works The CB Scheme is based on a structured process allowing international recognition of the tests performed: 1 - Definition of the regulatory framework Check for any national deviations.Carrying out tests 2 - Identification of the normative requirements of the target market. Tests carried out by an accredited CBTL testing laboratory.Verification of electrical performance, electromagnetic compatibility (EMC) and safety. 3- Issuing the CB certificate If the tests are conclusive, the National Certification Body (NCB) issues a CB Test Certificate.This certificate is recognised by all countries belonging to the CB scheme. 4 - Registration and recognition If the tests are conclusive, the National Certification Body (NCB) issues a CB Test Certificate.This certificate is recognised by all countries belonging to the CB scheme. 5 - Using the certificate Use of the CB certificate to avoid repeating tests in other countries.Easy access to local certification marks. Emitech is a National Certification Body (NCB) under the CB Scheme Find out more Talk to our experts about bringing products to market Contact us Advantages of the CB scheme Using the CB Scheme offers many advantages to manufacturers and exporters:Reduced time to market thanks to mutual acceptance of test results.Reduced costs by avoiding duplication of tests in several laboratories.Simplification of certification procedures, with a single testing campaign for several markets.Better management of resources by limiting the effort involved in administrative procedures.Reliability and regulatory compliance thanks to tests carried out in accredited laboratories. Member countries of the CB scheme The CB Scheme is recognised in over 50 countries, opening up international markets to you:Europe: France, Germany, United Kingdom, Spain, Italy, Sweden, etcNorth America: United States, Canada, Mexico.Asia-Pacific: China, Japan, South Korea, Australia, India, etcSouth America: Argentina, Chile.Middle East and Africa: Saudi Arabia, United Arab Emirates, etc Standards and certifications covered Our CB Scheme certification services cover a wide range of electrical and electronic equipment and IECEE international standards, including:Category OFF : IEC 60950-1 : Information Technology EquipmentCategory TRON : IEC 60065 : Audio, video and similar electronic apparatusCategory ITAV : IEC 62368-1 : Audio/video, information and communication technology equipmentCategory MEAS: IEC 61010-1 and parts 2: Electrical equipment for measurement, control and laboratory useCategory MED: IEC 60601-1 and parts 2: Medical electrical equipmentCategory EMC : IEC 61000-6-X, IEC 61326-X-X, CISPR 14, 32, 35... : Electromagnetic compatibilityView the official list of IECEE National Certification Bodies - Emitech Integrating the CB scheme into your export strategy Our experts can help you make the most of the advantages of the CB Scheme and optimise your regulatory procedures. We can help you to :Identify the necessary certifications for each target market.Implement an optimised certification strategy to reduce costs and lead times.Anticipate regulatory changes and ensure ongoing compliance.Centralise certification procedures for simplified management. Contact us for a quote Need fast, efficient international certification? Contact our experts for a tailored solution. Request a quote now

CE marking Optimise the procedures involved in placing your products on the European market The Emitech Group assists manufacturers, importers and distributors of electrical and electronic products in achieving the regulatory compliance required for marketing their products in the European Union. Thanks to our expertise in testing and certification in Electromagnetic Compatibility (EMC), electrical safety and radio testing, we secure access to the European market via CE marking. Ask for a quote Why choose the Emitech Group to help you with CE marking? CE marking and free movement of goods. We facilitate the CE marking process, which is essential for ensuring that equipment can be placed on the market and move freely within Europe.Accredited testing laboratories for tests required by the main directives (EMC, RED, Low Voltage).Our specialised laboratories carry out EMC, electrical safety and radio tests required by the RED (Radio Equipment Directive), EMC and Low Voltage (electrical safety) directives.Notified Body (NB 0536). Emitech Certification is a notified body (NB 0536) for the RED and EMC directives, enabling you to obtain CE marking when your equipment and its environment of use do not comply with the harmonised standards in force, thanks to conformity assessment procedures. It also ensures reliable regulatory validation as part of a voluntary approach.  Services to optimise your regulatory compliance demonstrations We offer comprehensive support to ensure your equipment complies with regulations:Identification of applicable standards and directivesRight from the design stage, we analyse your product to determine the essential requirements in terms of safety, electromagnetic compatibility and radio regulations.Laboratory evaluation and testingWe carry out technical tests to demonstrate compliance with harmonised standards and applicable regulations.Compilation of technical documentationWe assist you in compiling your technical documentation and mandatory documents (risk analysis, plans, diagrams, test reports).Drafting and validation of the EU declaration of conformityWe assist you in drafting your EU declaration of conformity, certifying compliance with regulatory requirements.Affixing the CE markingWe guide you through the final stages of placing your product on the market and affixing the CE marking. Our areas of expertise in CE marking: Directives and Regulations EMC Directive 2014/30/EU: Electromagnetic compatibility Control of electromagnetic emissions and immunity to interference.Laboratory tests in accordance with EN 61000, EN 55032, EN 55035, etc.Assistance with constitution of technical file, risk analysis and CE declaration.Involvement of a Notified Body if necessary. Low Voltage Directive 2014/35/EU: Electrical safety Verification of protection against electrical and thermal risks.Tests in accordance with standards EN 60335, EN 62368, EN 60601, etc.Validation of technical file and risk analyses. RED Directive 2014/53/EU: Radio equipment Testing for radio spectrum management and EMC compliance.Certification of Wi-Fi, Bluetooth, IoT, 5G, RFID equipment.Validation of RF performance and cybersecurity.Support from our notified body NB 0536. Machinery Directive 2006/42/EC (and Regulation 2023/1230) Validation of the Essential Health and Safety Requirements (EHSR). Mechanical, electrical and EMC tests on industrial machines. Assistance in obtaining CE marking. Preparation for the transition to the Machinery Regulation 2023/1230 (applicable in 2027). Medical Device Regulations (MDR 2017/745 & IVDR 2017/746) Assistance with constitution of the technical file (construction engineering in electrical safety) and risk analyses (Electrical Safety, EMC and Radio).Verification of the safety and performance of medical devices.Validation of biocompatibility procedures and EMC tests.Requirements management ISO 13485, ISO 14971, IEC 60601, IEC 62304. Emitech is a Notified Body for the purposes of CE marking Find out more Talk to our experts about bringing products to market Contact us Emitech - Notified Body (NB 0536) for CE certification Certification under the RED Directive (2014/53/EU) and the EMC Directive (2014/30/EU)Our Notified Body can issue : EU Type Examination Certificate (RED Directive 2014/53/EU)EU Type Examination Certificate (EMC Directive 2014/30/EU)Certification proceduresReceipt of applicationReview and drafting of quotationDocumentary analysis and technical assessmentCertification decision & issue of certificateEU Type Examination Certificate - Directive RED 2014/53/EUConformity of radio equipment (Wi-Fi, Bluetooth, IoT, 5G, GNSS, RFID...).EU Type Examination Certificate - EMC Directive 2014/30/EUValidation of electrical and electronic equipment against electromagnetic interference.Certification for UAVs - Directive 2019/945/EUConformity assessment of UAVs for CE marking. Comprehensive FAQ on CE marking What is CE marking? The CE marking indicates that the product complies with the essential requirements of the applicable European legislation, allowing it to circulate freely within the European market. Which products must carry the CE marking? CE marking is compulsory for all products covered by one or more European directives, such as electrical, electronic, radio or medical equipment. Where should the CE marking be affixed? The CE marking must be affixed directly to the product or to its identification plate. If this is technically impossible, it may be affixed to the packaging or accompanying documents. Which laboratories carry out the tests required for CE marking? The Emitech Group carries out accredited laboratory tests in Electromagnetic Compatibility (EMC), Radio and Electrical Safety to meet the requirements of the three corresponding directives. What exactly does CE marking mean on a product? By affixing the CE marking, the manufacturer declares under its sole responsibility that the product is in conformity with the essential requirements of the applicable European legislation, and that the relevant conformity assessment procedures have been followed. Is a product bearing the CE marking necessarily manufactured in the European Union? No, the CE marking only indicates that the product meets the essential requirements, but does not specify the geographical origin of the product. Do all CE-marked products require the intervention of a Notified Body? No. Only certain high-risk products (e.g. radio equipment, lifts, certain industrial equipment) require conformity assessment by a Notified Body. Who is responsible for affixing the CE marking? The manufacturer or his authorised representative established in the European Union is responsible for affixing the CE marking. However, if a distributor or importer markets a product under its own name, it assumes the manufacturer's responsibilities. What is the legal size of the CE marking? The minimum height of the CE marking is 5mm. However, exceptions are possible for very small products. Can a product with CE marking bear other markings? Yes, provided that these additional markings do not cause confusion with the CE marking, do not reduce its visibility and meet other specific requirements (e.g. energy labelling). What are the penalties for incorrect CE marking? Penalties vary according to the national legislation of the Member States. They may combine administrative penalties (withdrawal of the product from the market, consignment of the goods to the company's warehouse) and criminal penalties (fines and imprisonment). Where can I get more information? Further information on CE marking is available on the European Commission's official website: CE Marking. Why choose Emitech to make your products compliant? Complete expertise in EMC, electrical safety, radio frequency and mechanical testing.Accredited laboratories for reliable, standards-compliant testing.Notified Body (NB 0536) for rapid regulatory validation.End-to-end support: from design to market launch.Secure compliance and proactive regulatory monitoring.Possibility of integrating your regulatory procedures for your export markets. Contact us for a quote Need to undertake CE marking procedures for one of your products? Contact our experts for a tailored solution. Request a quote now

EMC Directive 2014/30/EU Essential electromagnetic compatibility requirements for your CE marking Why is the EMC Directive essential? Directive 2014/30/EU defines the essential electromagnetic compatibility (EMC) requirements for electrical and electronic equipment before it is placed on the European Union market. Its aim is to ensure that such equipment operates without causing or suffering harmful interference.Our services enable manufacturers, importers and distributors to :Ensure that equipment complies with electromagnetic compatibility requirements.Carry out EMC laboratory tests to verify compliance.Draw up the technical file and the EC declaration of conformity.Use harmonised standards to simplify compliance.Affix the CE marking and ensure that products are legally placed on the market.Working with a Notified Body where necessary. Ask for a quote Scope and obligations of manufacturers The directive covers a wide range of electrical and electronic equipment, with the exception of certain specific equipment such as non-marketed amateur radio equipment, radiocommunication and radio-determination equipment, electromedical equipment (subject to specific regulations), and certain aeronautical and automotive equipment:Household appliances and multimediaIndustrial and medical equipmentTelecom products and RF equipmentAutomotive, railway and aeronautical equipmentManufacturers must :Design equipment that complies with electromagnetic compatibility requirements.Carry out EMC tests and draw up technical documentation.Affix the CE marking after conformity assessment.Draw up an EU declaration of conformity and provide instructions.Call in a Notified Body for certain product categories. Key elements of the EMC Directive Essential requirements for electromagnetic compatibility The essential requirements of the directive cover :Electromagnetic emissions: limiting the disturbance produced by equipment.Electromagnetic immunity: resistance to external interference. Harmonised standards and certification The use of harmonised standards makes it easier to demonstrate compliance with the essential requirements.Here are some key standards:Generic standards :EN 61000-6-1: Immunity for residential, commercial and light industrial environments.EN 61000-6-2: Immunity for industrial environments.EN 61000-6-3 : Electromagnetic emissions for residential, commercial and light industrial environments.EN 61000-6-4 : Electromagnetic emissions for industrial environments.Product standards :EN 55032: Electromagnetic compatibility of multimedia equipment.EN 55035: Immunity of multimedia equipment.EN 50121: Electromagnetic compatibility for railway applications.EN 55011: Electromagnetic emissions of industrial, scientific and medical equipment.EN 60601-1-2: Electromagnetic compatibility of medical devices.EN 55014: Electromagnetic compatibility of household appliances and power tools....The list of harmonised standards is published and regularly updated in the Official Journal of the European Union Talk to our CE marking experts Contact us Conformity assessment procedures Equipment must follow one of the following procedures:Internal manufacturing control: internal assessment and technical file.EU type-examination: required for certain specific equipment.Assessment by a Notified Body in certain cases. Technical file and EMC tests We can help you put together the technical file, which includes :Description of the product and how it works.Technical drawings and diagrams.EMC test results and compliance certificates.Risk analysis and solutions implemented.Our laboratories carry out compliance tests:Measurement of electromagnetic emissions.Electromagnetic interference immunity tests.Specific tests depending on the environment of use. Why choose the expertise of the Emitech Group? Our services cover the entire compliance process:An open approach to all directives applicable to your productsRegulatory support: analysis of applicable requirements.Risk assessment and compilation of technical file.Laboratory tests and trials to guarantee compliance.Assistance in obtaining CE marking and certification.Involvement of a Notified Body if necessary. Contact us for a quote Do you need help to ensure that your equipment complies with the EMC directive? Contact our experts for a tailored solution. Request a quote now

Low Voltage Directive 2014/35/EU The safety of people and their property in the context of CE marking Why is the Low Voltage Directive essential? Directive 2014/35/EU, known as the Low Voltage Directive (LVD), defines the electrical safety requirements for equipment intended for use at a nominal voltage of between 50V and 1000V for alternating current and between 75V and 1500V for direct current. Its aim is to guarantee user safety and ensure the free movement of compliant equipment within the European Union.Our services enable manufacturers, importers and distributors to :Ensure that equipment complies with electrical safety requirements.Carry out laboratory tests to verify product safety.Draw up the technical file and the EC declaration of conformity.Use harmonised standards to simplify compliance.Affix the CE marking and guarantee that products are legally placed on the market. Ask for a quote Scope and obligations of manufacturers The directive covers a wide range of electrical equipment:Household appliancesIT and multimedia equipmentIndustrial and professional equipmentConsumer equipmentLighting equipmentManufacturers must :Design equipment that complies with electrical safety requirements.Carry out safety tests and draw up technical documentation.Affix the CE marking after conformity assessment.Draw up an EU declaration of conformity and provide instructions. The key elements of the Low Voltage Directive (LVD) Essential electrical safety requirements The essential requirements of the directive cover :Protection against hazards arising inside equipment to prevent :injury or other damage through direct or indirect contactdangerous temperatures, arcs or radiationnon-electrical hazards known from experienceinsulation adapted to the expected stresses...Protection against hazards arising from external action on the equipment:compliance with mechanical requirementsresistance to non-mechanical influences in the intended environmentabsence of danger under the anticipated overload conditions Harmonised standards and certification The use of harmonised standards makes it easier to demonstrate compliance with the essential requirements.Here are some key standards:EN 60335-1: Safety of household and similar electrical appliances.EN 62368-1: Safety of audio/video, information and communication technology equipment.EN 60204-1 : Safety of electrical equipment of machines.EN 61010-1 : Safety of electrical equipment for measurement, control and laboratory use...The Low Voltage Directive also makes use of EMF standards (human exposure to electromagnetic fields): EN 62311, EN 62233, EN 50364, etc.The list of harmonised standards is published and regularly updated in the Official Journal of the European Union Talk to our CE marking experts Contact us Technical file and safety tests We can help you put together the technical file, which includes :Description of the product and how it works.Technical drawings and diagrams, parts listLabel plan, user/installer manualResults of safety tests and compliance certificates.Risk analysis and solutions implemented. Our laboratories carry out the documentary and construction analysis, as well as the safety tests required by the applicable standards:Dielectric strength testEarth continuity measurementMechanical resistance tests (constant force, steel ball impact, drop)Temperature rise measurements... Why choose the expertise of the Emitech Group? Our services cover the entire compliance process:An open approach to all directives applicable to your productsRegulatory support: analysis of applicable requirements.Risk assessment and compilation of technical file.Laboratory testing to guarantee compliance.Assistance in obtaining CE marking and certification.Involvement of a Notified Body if necessary. Contact us for a quote Do you need help to ensure that your equipment complies with the Low Voltage Directive (LVD)? Contact our experts for a tailored solution. Request a quote now

Machinery Directive 2006/42/EC Compliance and marketing Why is the Machinery Directive essential? Directive 2006/42/EC, known as the Machinery Directive, defines the essential health and safety requirements (EHSRs) applicable to industrial equipment before it is placed on the European Union market. Its aim is to ensure the safety of operators and users, while facilitating the free movement of compliant machinery within the EU. Our services enable manufacturers, importers and distributors to :Ensure that machinery complies with safety requirements.Obtain CE marking and guarantee that machinery is placed on the market legally.Draw up the technical file and carry out the risk analysis.Use harmonised standards to facilitate compliance.Collaborate with Notified Bodies if necessary. Ask for a quote Scope and obligations of manufacturers The directive covers a wide range of equipment, including :Machinery: any assembly of linked parts, equipped with a drive system, intended for a specific application.Safety components: elements providing a protective function.Interchangeable equipment: devices which modify the main function of a machine.Lifting accessories and quasi-machines (incomplete machines to be integrated into a final assembly).Certain categories, such as road vehicles and machinery for military or nuclear use, are excluded because they are covered by other regulations.Manufacturers must :Design machines that comply with the essential safety requirements (EESS).Carry out a risk analysis and compile a technical file.Affix the CE marking after following the appropriate assessment procedure.Draw up an EC declaration of conformity and provide instructions.Use a Notified Body for certain high-risk machines. The key elements of the Machinery Directive Essential health and safety requirements (EHSR) EHSR covers many aspects of machine safety, including :Mechanical safety (protection against cuts, crushing, falling parts, etc.).User safety for protection against electric shock and electromagnetic compatibility (EMC).Thermal and fire risk.Protection against hazardous substances and radiation.Ergonomic measures and noise and vibration reduction. Harmonised standards and certification Applying harmonised standards makes it easier to demonstrate compliance with the essential requirements. Some key standards :EN ISO 12100: General principles for design, risk assessment and risk reduction.EN 60204-1: Safety of machinery - Electrical equipment of machinesEN ISO 13849-1: Reliability of safety-related control systems.ISO 13857: Safety distances to prevent access to hazardous areas.EtcMachinery designed in compliance with harmonised standards is presumed to comply with the directive. Conformity assessment procedures Machines must undergo one of the following assessment procedures:Internal manufacturing control : The manufacturer carries out the assessment himself and compiles the technical file (except if annex 4, otherwise annex x ok).EC type-examination: For high-risk machinery (annex IV of the directive), the intervention of a Notified Body is required.Full quality assurance: Assessment of a quality system covering design and manufacture. The CE marking is then affixed, attesting to the machine's conformity. Note that a declaration of incorporation replaces a quasi-machine. Talk to our CE marking experts Contact us Technical file and risk analysis We can help you compile your technical file, which must include :Description of the machine and how it works.Drawings and technical diagrams.List of harmonised standards applied.Test results and certificates of conformity.Risk analysis and solutions implemented.The risk assessment includes the following elements:The risk assessment process is a documented physical examination and machine inspection carried out in accordance with the recommendations of national standards.Risk assessments must be dynamic, risks must be re-assessed in the event of changes;The risk assessment must cover all phases of its life cycle (transport, use, disposal, etc.).The risk assessment must also cover all persons interacting with the machine.The risk assessment must take account of normal use and reasonably foreseeable misuse.The risk analysis is based on the following approach:Define the intended use and reasonably foreseeable misuseIdentify the hazardous phenomenaAnalyse the risks associated with the hazardous phenomenaEstimate the risksIf the risk is not tolerable, reduce the riskRisk reduction** is based on three principles:Elimination / substitution of the hazard.Implementation of protective measures (isolation from the hazard).Informing users of risks (manuals, training and PPE). Testing and validation of compliance Our laboratories carry out compliance tests covering :Mechanical safety: strength, stability and fatigue tests.Electrical safety: checking circuits, insulation, earthing.EMC testing: electromagnetic compatibility to ensure interference-free operation.Thermal and fire protection testing. Regulation 2023/1230: Transition and development of the directive From 20 January 2027, Directive 2006/42/EC will be replaced by Regulation (EU) 2023/1230, which introduces :Uniform application without national transposition, avoiding regulatory divergences.Incorporation of new cybersecurity and artificial intelligence requirements.Extended definitions of machinery and related products.Digitisation of technical documentation and instruction manuals.Clarification of the obligations of manufacturers, importers and distributors.Our experts are here to help you anticipate these changes and ensure seamless compliance. Multi-regulatory compliance for CE marking The Machinery Directive 2006/42/EC and the Machinery Regulation 2023/1230 constitute the principal basis for CE marking of machinery, but depending on the nature of the machinery and the environment in which it is used, other directives and regulations may also apply.It is necessary to determine all the associated CE requirements:Identify specific risks (electrical, ATEX, EMC, etc.).Check if other directives are applicable in addition to the Machinery Regulations.Apply the relevant harmonised standards for each regulation.Carry out the necessary tests and assessments (often with Notified Bodies in certain cases).Compile a complete technical file of conformity.Draw up an EU Declaration of Conformity mentioning all applicable directives.Affix the CE marking only once all the requirements have been met. Why choose the expertise of the Emitech Group? Our services cover the entire compliance process:Regulatory support: analysis of applicable requirements.Risk assessment and compilation of technical file.Laboratory tests and trials to guarantee compliance.Assistance in obtaining CE marking and certification.Involvement of a Notified Body if necessary. Contact us for a quote Do you need help to ensure the compliance of your industrial machinery? Contact our experts for a tailored solution. Request a quote now

RED Directive 2014/53/EU Optimised management of the frequency spectrum for CE marking purposes Why is the RED directive essential? Directive 2014/53/EU, known as the RED (Radio Equipment Directive), establishes a uniform regulatory framework for the placing on the market of radio equipment in the European Union. It aims to guarantee user safety, electromagnetic compatibility and the efficient use of the radio spectrum, while facilitating the free movement of compliant equipment.Our services enable manufacturers, importers and distributors to :Ensure that radio equipment complies with the essential requirements.Obtain the CE marking and guarantee that equipment is legally placed on the market.Compile a complete technical file and carry out the necessary tests.Use harmonised standards to facilitate compliance.Working with Emitech Certification, Notified Body for the RED Directive. Ask for a quote Scope and obligations of manufacturers The RED Directive applies to any equipment which intentionally emits or receives radio waves, including :Smartphones, tablets, connected objects (IoT), 5G equipment.RFID devices, LoRa/Sigfox networks, GNSS navigation equipment.Radar, radiodetermination devices and broadcast receivers (radio, TV).Manufacturers must :Design equipment that complies with the essential requirements (electrical safety, EMC, radio spectrum, cybersecurity and human exposure to electromagnetic fields).Carry out a risk analysis and compile a technical file.Affix the CE marking after following the appropriate assessment procedure.Provide an EU declaration of conformity and instructions for use.Collaborate with a Notified Body for certain categories of equipment. Key elements of the RED directive Essential compliance requirements The essential requirements cover :Electrical and thermal safety (protection against shock, fire, etc.).Electromagnetic compatibility (EMC) (absence of harmful interference).Efficient use of the radio spectrum (compliance with transmission standards).Cybersecurity and data protection (for certain connected equipment, mandatory from August 2025).Interoperability and accessibility to emergency services (for smartphones, regulation 2019/320). Harmonised standards and certification Applying harmonised standards gives a presumption of conformity with the essential requirements. Key standards include :EN 300 328: Standard for 2.4 GHz Bluetooth/Wi-Fi equipment.EN 301 489-x: Electromagnetic compatibility of radio equipment.EN 62368-1: Electrical safety of ICT and radio equipment.EN 18031-x: Cybersecurity requirements for connected objects.An assessment by a Notified Body is necessary when the harmonised radio spectrum and cybersecurity standards are not fully applied in accordance with Article 14 of the RED Directive 2014/53/EU. Conformity assessment procedures Manufacturers can follow one of the following procedures:Internal production control (Module A) : Self-declaration on the basis of harmonised standards.EU Type Examination (Modules B+C): Involvement of Emitech Certification for product validation.Total Quality Assurance (Module H): assessment and certification of a complete quality system. Talk to our CE marking experts Contact us Notified Body (NB) and EU Type Examination Why use a Notified Body? A Notified Body (NB) is an organisation designated by an EU Member State to assess the conformity of certain products before they are placed on the market. Where no harmonised standard is yet available, or where the manufacturer does not wish to apply all or part of a harmonised standard, he must seek the opinion of a NB to validate the conformity of his radio equipment.Its role:Examine the technical design of the equipment and the risk analysis carried out by the manufacturer.Certify product quality through inspection of the manufacturer's quality system and surveillance audits.Issue an EU type-examination certificate under the RED Directive 2014/53/EU.Communicate with market surveillance authorities and other Notified Bodies.Guarantee an independent, transparent and impartial assessment. EU type examination EU type-examination is an assessment procedure whereby a Notified Body certifies that a product model meets the essential requirements of the RED directive. This examination involves :In-depth analysis of the technical documentation supplied by the manufacturer.Validation of the tests carried out to prove conformity.Issuing an EU type-examination certificate, which is required before the product can be placed on the market.The benefits of an EU type-examination:Provide the authorities with all the necessary proof of conformity.Secure marketing with independent validation.Benefit from regulatory and technical monitoring by a specialist body.Protect against compliance problems (market withdrawals, litigation, competitive risks).Easier access to new markets thanks to the international recognition of certificates. Emitech Certification : Notified Body RED Emitech Certification is a Notified Body (NB 0536) for the RED directive. We carry out :The EU type examination for equipment not fully applying the harmonised standards.The audit and certification of manufacturers' quality systems under module H.Regulatory and technical monitoring** to ensure ongoing product compliance.Our expertise enables us to speed up the process of obtaining the necessary certificates and ensure that products are placed on the market in complete safety. Why choose the expertise of the Emitech Group? Our services cover the entire compliance process:An open approach to all directives applicable to your productsRegulatory support: analysis of applicable requirements.Risk assessment and compilation of technical file.Laboratory testing to guarantee compliance.Assistance in obtaining CE marking and certification.Involvement of a Notified Body if necessary. Contact us for a quote Need help to ensure your equipment complies with the RED directive? Contact our experts for a tailored solution. Request a quote now

Medical Device (MD) and IVDD regulations Make a success of your CE marking Why ensure regulatory compliance for medical devices? European Regulations (EU) 2017/745 (MDR on Medical Devices) and (EU) 2017/746 (IVDR on In Vitro Diagnostic Medical Devices) aim to enhance patient safety, device performance and market surveillance. They impose strict requirements on manufacturers to ensure a high level of quality and traceability.Our services enable manufacturers to:Define the applicable regulatory scopeSecure the design through pre-qualification analysesOptimise qualification and production costsEnsure compliance with MDR and IVDM regulations.Obtain CE marking and access European and international markets.Validate critical manufacturing processes (transport, packaging, tropicalisation, harsh environments).Train teams in regulatory and standard requirements.Implement recurring series testing during manufacturingPrepare clinical evaluations Ask for a quote Main requirements of RDM and RDM DIV regulations. Device classification MDD: Devices are classified into classes I, IIa, IIb and III according to their intended use and level of risk.iVDD: Four classes A, B, C and D, depending on the intended use, with a significant increase in controls (90% of IVDDs require assessment by a Notified Body, compared with 15% previously). General Safety and Performance Requirements (GSPR) Compliance with current standards in terms of :Risk management according to ISO 14971.Basic safety and essential performance.Electromagnetic compatibility/RadioJustification of hazardous substances and consideration of cybersecurity. Clinical and performance evaluation MD: Obligation to provide solid clinical data (studies, literature, etc.).IVDD: Validation of analytical and clinical performance. Quality management system (ISO 13485) Implementation of a compliant quality system covering design, production and post-market surveillance.Appointment of a Person Responsible for Regulatory Compliance (PRRC). Technical documentation and declaration of conformity RDM and RDM DIV technical file** with a description of the device, design, risk analysis, test reports, labelling and user documentation.EU Declaration of Conformity attesting to compliance with regulatory requirements. Registration and traceability (EUDAMED, UDI) Registration of devices and economic operators in EUDAMED.Allocation of a Unique Identifier (UDI) for each device. Post-market surveillance and vigilance Implementation of a post-marketing surveillance plan (PMS).Periodic safety reports (PSUR) and reinforced vigilance. Tests required for compliance The conformity assessment stage is essential for manufacturers. The choice of laboratory to assess the conformity of medical devices requires technical and normative skills in many fields. Basic safety and performance Verification of electrical, mechanical, fluid and performance risksCompliance with IEC 60601-1 (DM) and IEC 61010-2-101 (IVDD) standards. Electromagnetic compatibility (EMC) Emission and immunity tests to guarantee reliability.Applicable standards: IEC 60601-1-2 (DM) and IEC 61326-2-6 (IVDD). Performance testing Verification of measurement accuracy and reproducibility.In vitro and in vivo tests for diagnostic performance. Environmental and reliability testing Climatic (temperature, humidity) and mechanical (vibration, shock) tests.Checking the robustness and lifespan of the device. Talk to our experts in CE marking for your DM and IVD DM Contact us Biocompatibility and biological safety (ISO 10993) Cytotoxicity, irritation and systemic toxicology tests to assess the biocompatibility of materials in contact with the human body. Cybersecurity and embedded software Validation of medical software according to IEC 62304, IEC 82304Cybersecurity risk assessment (IEC 81001-5-1). Access to international markets In addition to European conformity, we make it easier to export devices thanks to :CB Schemes: International recognition of tests.FDA clearance (510(k)) for the US market.Specific certifications for over 50 countries Training and regulatory support We offer specialised training courses to help you master regulatory and standards requirements:IEC 60601: General safety requirementsIEC 60601-1-2: EMC construction rulesISO 14971: Risk management applied to medical devices.IEC 62366-1 : Fitness for use and ergonomics of devices.IEC 62304: DM softwareRequirements according to RDM and RDM DIV Why choose the expertise of the Emitech Group? Our services cover the entire life cycle of medical devices:Regulatory support and compliance matrix.Carrying out laboratory and in situ testsHelping to optimise the cost of qualification and productionOur recognised technical expertise in all areas of medical devices and IVDs (from implants to machines)Accelerated access to international markets. Contact us for a quote Do you need support to ensure the compliance of your medical devices? Contact our experts for a tailored solution. Request a quote now

UKCA marking & UKNI marking Access to the UK market and post-Brexit regulation Why is UKCA marking essential for marketing in the UK? Since the United Kingdom left the European Union, the regulatory compliance requirements for placing products on the market have changed. The UKCA marking (UK Conformity Assessed) has become the UK equivalent of the CE marking and is mandatory for selling certain products in Great Britain (England, Wales and Scotland). It co-exists with the UKNI mark for the Northern Ireland market.Our services enable manufacturers, importers and distributors to :Understand and apply the requirements of UKCA marking and UKNI.Ensure product compliance with UK regulations.Identify the Notified Bodies responsible for conformity assessment.Ensure the transition from CE marking to UKCA and UKNI.Facilitate access to markets in Great Britain and Northern Ireland. Ask for a quote Post-Brexit regulatory context On 1 January 2021, the UK introduced the UKCA marking to gradually replace the CE marking. However, the UK Government announced on 1 August 2023 that the CE marking will remain valid indefinitely for many products sold in the UK.This decision provides manufacturers with increased flexibility, allowing them to continue to use either the CE marking or the UKCA marking after December 2024, except for certain specific product categories. Which products are covered by UKCA marking? The UKCA marking applies to electrical and electronic products, household appliances, industrial equipment, information technology and medical devices, among others.The products that must carry the UKCA marking after December 2024 are those requiring assessment by a UK Notified Body. What are the differences between CE marking, UKCA marking and UKNI marking? MarkingZones concernedRecognitionEuropean Union, Northern Ireland Valid in the United Kingdom until further noticeUKCAGreat Britain (England, Wales, Scotland)Not valid in the EUValid only with CE marking How to obtain UKCA marking Conformity assessment procedure Determine whether the product falls under a regulation requiring UKCA certification.Check whether self-certification is possible or whether a third-party body is required. Testing and certification Tests carried out by a UK Approved Body.Verification of essential requirements equivalent to European standards. Documentation and marking Drawing up of the UKCA Declaration of Conformity, indicating the standards applied and the manufacturer's responsibilities.Permanent affixing of the UKCA marking from January 2025.Retention of technical documents for 10 years after the product is placed on the market. UKNI marking for Northern Ireland Northern Ireland remains aligned with EU regulations, which means that :CE marking is still required** to sell products in Northern Ireland.If a product is certified by a UK Notified Body, it must carry UKNI marking in addition to the CE marking.A product bearing the CE + UKNI marking cannot be sold in the EU. Talk to our experts in CE marking, UKCA and UKNI Contact us Specific requirements and exceptions The UKCA marking does not apply to the following products, which remain governed by other regulations:Medical devicesConstruction productsRailway productsMarine equipmentUnmanned aircraft systemsSpecific rules for these categories will be clarified by the UK government. The special case of medical devices As with other equipment, UKCA marking has been in force since 1 January 2021 for Great Britain, and CE marking (with the possible addition of UKNI) remains in force for Northern Ireland. The UK medical device market is regulated by the MHRA (Medicines and Healthcare products Regulatory Agency).Following Brexit, UK regulations are gradually moving away from European standards, which has led to the introduction of UKCA marking for medical devices (MDs). The July 2024 deadline marked a key milestone in the replacement of CE marking with UKCA marking in Great Britain (England, Scotland, Wales). Manufacturers had to start adapting to this change to avoid any market disruption. However, in 2023, the UK government decided to extend the transition periods for the use of CE marking in Great Britain to give businesses more time to adapt. This extension varies depending on the type of product, and for MDs, the transition period can last until 30 June 2026. MDs that already bear the CE marking can therefore continue to be marketed in Great Britain until that date.  Why choose the expertise of the Emitech Group? Our experts will work with you to facilitate your access to the UK market by helping you to :Understanding applicable regulations and certification requirements.Setting up an appropriate compliance process to avoid administrative bottlenecks.Manage the transition to UKCA marking or UKNI to ensure continuity of sales in the UK.Optimise technical documentation and declarations of conformity Contact us for a quote Need help with UKCA and UKNI compliance? Contact our experts for a tailored solution. Request a quote now