CE Marking & CE Certification Support
CE marking is a manufacturer’s declaration of conformity, not a certificate issued by an external authority. InTechHouse supports the CE marking process by defining the applicable EU requirements, preparing products for testing, coordinating conformity assessment, and building the technical documentation needed for the EU Declaration of Conformity.
Measured impact on EU market access
CE marking connects product design, testing, documentation, and manufacturer responsibility into one conformity process.
How we take an electronic product through CE conformity
CE conformity starts by identifying the legal requirements that apply to the particular product. Testing comes after the regulatory scope, intended use, product architecture, and applicable standards have been defined.
Defining the applicable requirements
- Identify the EU directives and regulations covering the product.
- Determine which essential requirements apply to its intended use and product model.
- Select relevant harmonised standards and check their current status.
- Determine whether manufacturer self-assessment is permitted or a notified body must participate.
- Define EMC testing, safety testing, radio, material, mechanical, or other testing requirements.
- Review whether multiple legal acts apply to the same product.
Building the conformity evidence
- Perform risk assessment and identify design changes needed for compliance.
- Run pre-compliance EMC and safety testing before formal product testing.
- Coordinate accredited laboratory testing where required.
- Collect calculations, drawings, specifications, test reports, and product compliance evidence.
- Prepare the technical documentation around the applicable directives and regulations.
- Draft the EU Declaration of Conformity for manufacturer approval and signature.
- Verify product marking, labels, instructions, and traceability information before market release.
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What defines a CE-ready product file
A CE-ready product combines a compliant design with traceable evidence that explains how each applicable legal requirement has been addressed.
Test reports, design calculations, risk assessment, drawings, specifications, and standards references demonstrate how the product meets the essential requirements relevant to its intended use.
EMC testing, electrical safety checks, radio assessment, and other high-risk tests are performed early enough to correct the hardware before the formal testing process begins.
The product model, BOM, firmware, enclosure, labeling, instructions, and manufacturing controls remain consistent with the configuration represented by the technical documentation and Declaration of Conformity.
In-house scope vs. accredited laboratory
CE marking can involve engineering consultancy, laboratory testing, conformity assessment, and sometimes a notified body. These roles are different.
What InTechHouse does in-house
Engineering work can address PCB design, shielding, filtering, grounding, power supplies, insulation, enclosure construction, connectors, radio integration, hazardous substances documentation, and product labeling.
What an accredited laboratory does
An accredited laboratory is not automatically an EU notified body. A notified body is a conformity assessment body formally notified for specific EU legislation and conformity assessment tasks. Some products can use manufacturer self-assessment, while others require notified body involvement.
CE directives, regulations and harmonised standards
The applicable CE marking requirements depend on product function, voltage, radio capability, intended use, materials, and sector. One electronic product can fall under several EU directives or regulations at the same time.
The EMC Directive requires apparatus to control electromagnetic emissions and maintain adequate immunity to electromagnetic disturbances.
For electronic equipment, this typically drives conducted and radiated emissions testing, immunity testing, PCB layout, filtering, shielding, grounding, cabling, and enclosure design. The manufacturer prepares technical documentation, conducts the relevant conformity assessment, issues the EU Declaration of Conformity, and affixes the CE marking.
The LVD addresses safety objectives for electrical equipment within its scope. Compliance work can include protection against electric shock, insulation, temperatures, mechanical hazards, abnormal operation, fire risks, and other electrical safety requirements.
Its conformity assessment uses internal production control, with the manufacturer responsible for the technical documentation, risk analysis, Declaration of Conformity, and CE marking.
The RED applies to radio equipment and combines safety, EMC, and efficient use of radio spectrum requirements, plus other essential requirements where applicable.
A pre-certified radio module can reduce part of the engineering workload, but integration into the final product still requires assessment of the finished equipment. Depending on the conformity route and use of harmonised standards, notified body involvement can also be required.
RoHS restricts specified hazardous substances in electrical and electronic equipment within its scope. Manufacturers must establish technical documentation, conduct the applicable conformity assessment, issue an EU Declaration of Conformity, and affix CE marking.
RoHS compliance therefore belongs in the same product conformity file rather than being treated only as a supplier declaration exercise.
Medical devices follow the MDR conformity assessment framework. The route depends strongly on device classification and characteristics.
Some Class I medical devices can use manufacturer declaration, while higher-risk devices and certain Class I variants require notified body involvement. Technical documentation, risk management, clinical evidence, post-market obligations, and applicable product safety standards all form part of the broader MDR compliance case.
As of September 2026, machinery is still governed by Directive 2006/42/EC where applicable. Regulation (EU) 2023/1230 will apply on 20 January 2027, replacing the Machinery Directive (EU, 2023).
Projects reaching the European market around that transition should therefore establish early which legal framework will apply when the machinery is placed on the market.
Typical failure modes and the design fixes that prevent them
CE testing failures often reveal decisions made much earlier in the design process. Pre-compliance helps isolate these problems while schematic, PCB, enclosure, or component changes remain practical.
Symptom: conducted or radiated emissions exceed the applicable EMC limits.
Mechanism: switching converters, clocks, cables, enclosure openings, or poor PCB return paths create uncontrolled electromagnetic energy.
Fix: revise filtering, PCB layout, return paths, cable shielding, enclosure bonding, connector termination, and switching behavior.
Symptom: ESD, RF, EFT, or surge testing causes resets, corrupted measurements, communication loss, or permanent damage.
Mechanism: external disturbances couple into sensitive circuits through interfaces, power leads, enclosure apertures, or inadequate grounding.
Fix: improve transient protection, filtering, grounding, shielding, isolation, connector design, and firmware recovery behavior.
Symptom: insulation, leakage current, temperature, dielectric strength, or protective earth tests fail.
Mechanism: creepage and clearance, insulation systems, component ratings, grounding, or thermal design do not meet the applicable safety requirements.
Fix: revise insulation architecture, PCB spacing, protective components, earth connections, materials, enclosure construction, and thermal management.
Symptom: the test results are acceptable, but the product file does not demonstrate conformity.
Mechanism: applicable legislation, risk assessment, standards, test reports, drawings, product variants, or traceability records are missing or inconsistent.
Fix: build a requirements matrix and align the technical documentation, test evidence, product configuration, labeling, and Declaration of Conformity.
Use Cases
We design and develop embedded systems for UAV platforms, integrating sensors, communication modules, and control logic for real-time operation. Our solutions are engineered for mission-critical environments, ensuring reliable performance, low latency, and seamless system integration. Each design supports stable operation under dynamic conditions while maintaining data integrity and operational efficiency.
We design and develop firmware for industrial equipment, enabling reliable communication, data acquisition, and system control under real operating conditions. We focus on robustness, real-time performance, and seamless integration with hardware and higher-level systems. Each implementation provides stability, scalability, and long-term maintainability in demanding industrial environments. We als optimize for resource efficiency and compliance with industry protocols.
We design and develop firmware for subsea systems focusing on predictable real-time operation, fault tolerance, and robust communication in harsh underwater environments. Each implementation allows consistent performance under pressure, limited accessibility, and long-term deployment conditions. We also support integration with monitoring and diagnostic systems to enable remote operation and maintenance.
We design and implement advanced embedded software for imaging systems, including real-time processing, camera control, and data integration. Our solutions are optimized for high performance, low latency, and seamless interaction with hardware components. Each implementation ensures stable operation, high data throughput, and reliable system behavior. We also support integration with higher-level systems and data pipelines for end-to-end functionality.
Industries We Serve
Our engineering capabilities are deployed across regulated, mission-critical and industrial sectors.
Subsea electronics, downhole systems and harsh-environment hardware for offshore and onshore operations.
Mission-critical embedded systems and real-time firmware for UAV platforms and defence electronics.
Real-time embedded firmware for gas detection, environmental sensing and worker alert systems.
Embedded systems and real-time firmware for industrial automation,
machine control and IoT data acquisition.
Technologies we use
CE conformity work combines EMC diagnostics, electrical safety measurement, radio testing, environmental testing, and design verification tools selected around the applicable product requirements.
FAQs
If you have additional questions or would like to discuss your requirements, feel free to get in touch with our team.
“CE certification” is commonly used as a search term, but CE marking is usually not a certificate issued by the EU or a testing company. By affixing the CE mark, the manufacturer declares that the product complies with the applicable EU legislation and takes responsibility for that conformity.
A notified body becomes involved only when the applicable legislation and conformity assessment procedure require it.
For many products, yes. EU legislation often allows manufacturers to perform the applicable conformity assessment, prepare technical documentation, issue the Declaration of Conformity, and legally apply the CE marking without obtaining a generic CE certificate.
Other products require an EU notified body. The correct route depends on the particular product, applicable directive or regulation, risk classification, and conformity assessment procedure.
CE marking is mandatory only for products covered by EU legislation that specifically requires it. It must not be placed on products outside the scope of such legislation.
For products covered by CE marking requirements, conformity must be established before they are placed on the relevant European market.
There is no fixed CE marking cost. It depends on the applicable directives or regulations, number of standards, product complexity, testing requirements, design maturity, laboratory work, documentation gaps, and whether a notified body is required.
A simple product using manufacturer conformity assessment can require much less external work than medical devices, radio equipment with complex testing needs, or products requiring third-party conformity assessment.
Start by identifying the applicable EU directives or regulations and their essential requirements. Then select relevant standards, assess risks, design and test the product, compile technical documentation, complete the required conformity assessment, issue the EU Declaration of Conformity, and affix the CE marking.
The European Commission describes this as a six-step manufacturer process.
A product that requires CE marking but does not meet the applicable compliance requirements can be subject to corrective action, sales restrictions, withdrawal, or recall. Market surveillance authorities can also require missing or incomplete technical documentation and declarations to be corrected.
Penalties depend on the applicable legislation and national enforcement rules.
No. CE marking is part of the EU and EEA product regulatory framework. UL certification is a third-party product safety certification associated primarily with North American markets, while FCC requirements address radio-frequency and electromagnetic emissions for relevant products in the United States.
CE marking therefore does not replace FCC certification, UL assessment, or local regulations required for global market access in markets such as North America, South America, or the Middle East.
The CE symbol alone is not proof that a product is compliant. A manufacturer should be able to identify the applicable legislation and provide the required EU Declaration of Conformity, while technical documentation and test reports support the conformity claim.
Where a notified body is involved in the applicable production conformity procedure, its identification number may appear with the CE marking as required by the relevant legislation.
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