What Does CE Marking Cost for Your Product?

CE certification costs range from a few hundred dollars for simple electronics to $25,000 or more for medical devices—and the spread catches most teams off guard. The price depends on your product type, which EU directives apply, and whether a third-party organization has to sign off on your work.

This guide breaks down the real cost drivers, shows you where the money goes, and explains how to avoid the budget surprises that derail product launches.

How much does CE certification cost

CE certification typically costs anywhere from a few hundred dollars for simple battery-powered electronics to $25,000 or more for complex medical devices. The range is wide because the price depends on what you're selling, how risky it is, and whether a third-party organization has to review your work. Most hardware teams land somewhere between $1,000 and $15,000, though wireless products and regulated categories like machinery or personal protective equipment tend to push toward the higher end.

Here's a quick look at what different product types typically cost:

One thing worth clarifying upfront: CE marking is the EU's mandatory conformity marking. It signals that a product meets European health, safety, and environmental requirements. It's not a quality certification or an award—it's simply the legal prerequisite for selling in the European market.

What factors affect CE certification price

So why does one product cost $500 to certify while another costs $20,000? Five main variables drive the difference.

Product type and risk classification

Higher-risk products require more rigorous assessment. A simple LED lamp follows a straightforward path with minimal documentation. A Class IIa medical device, on the other hand, triggers mandatory third-party review, clinical evaluation, and ongoing surveillance. The more potential harm a product could cause, the more documentation and testing the EU requires—and the higher the cost.clinical evaluation costing €30,000-€100,000, and ongoing surveillance. The more potential harm a product could cause, the more documentation and testing the EU requires—and the higher the cost.

Applicable EU directives and standards

EU directives are the laws that set safety requirements for different product categories. Your product might fall under one directive or several, and each directive has its own testing requirements.

Common directives include:

• EMC Directive (2014/30/EU): Covers electromagnetic compatibility—making sure your product doesn't interfere with other electronics
• LVD (2014/35/EU): Safety requirements for electrical equipment operating between 50–1000V AC
• RED (2014/53/EU): Radio equipment including Wi-Fi, Bluetooth, and cellular
• Machinery Directive (2006/42/EC): Safety requirements for machines and mechanical equipment
• MDR (2017/745): Medical device regulation with strict clinical and documentation requirements

A product with wireless functionality, for example, triggers RED testing on top of EMC and LVD. That alone can add $1,000 or more to the project.

Self-certification vs Notified Body involvement

Most consumer electronics and general hardware can be self-certified. In this case, the manufacturer conducts testing, compiles documentation, and signs the Declaration of Conformity without any third-party involvement.

However, certain product categories require a Notified Body—an EU-designated organization that reviews your technical file and issues a certificate. Notified Body fees typically start around $5,000 and can exceed $15,000 for complex products. Annual surveillance fees often apply as well.According to industry analysis, the average application fee across 20+ EU Notified Bodies is €1,540, with average hourly rates for QMS Audits at €325 and Technical File review at €317. Annual surveillance fees often apply as well.

Testing scope and lab fees

Lab testing is often the largest single line item. EMC testing for a basic product might run $400–$800, while a wireless device with multiple radio technologies can cost $2,000–$4,000 in testing alone.

Several factors push lab fees higher:

• Multiple frequency bands: Wi-Fi, Bluetooth, and LTE each require separate testing
• Combined testing: Products requiring both EMC and safety testing (LVD) cost more than EMC-only
• Rush fees: Expedited testing slots typically add 25–50% to the base cost
• Re-testing: Failures mean additional rounds of testing at additional cost

Documentation and technical file preparation

The technical file is the core deliverable for CE marking. It includes design specifications, risk assessments, test reports, user manuals, and labeling. Preparing this documentation takes time—either internal engineering hours or consultant fees.

Incomplete or poorly organized documentation is one of the most common causes of project delays. When documentation gaps surface during testing or review, the rework adds both time and cost.

CE certification cost breakdown by component

Where does the money actually go? Here's how costs typically break down:

Consultant and compliance service fees

Compliance consultants provide regulatory guidance, gap assessments, and project management. Fees scale with product complexity and the number of applicable directives. Some teams handle this work internally, though that requires existing regulatory expertise and familiarity with the relevant standards.

Laboratory testing costs

Testing fees depend on which directives apply and how complex your product is. Labs charge for equipment time, engineer hours, and report generation.

Queue times vary significantly. Popular labs may have 4–8 week backlogs, and if you're in a hurry, rush fees can add 25–50% to the base cost. Planning ahead helps avoid this premium.

Notified Body fees

When required, Notified Body fees cover technical file review, facility audits (for some product types), and certificate issuance. Annual surveillance fees apply for as long as you sell the product. For regulated product categories, these fees are unavoidable.

Technical documentation costs

The technical file, user instructions, risk assessment, and Declaration of Conformity all require preparation. Teams with in-house expertise can handle this work directly. Others outsource to consultants or use documentation automation toolsto reduce manual effort and catch gaps early.

Do you need a Notified Body for CE marking

This question has the biggest impact on your budget. The answer depends entirely on your product category and risk classification.

When self-certification applies

Most products can be self-certified. The manufacturer takes full responsibility for compliance, conducts or commissions testing, and signs the Declaration of Conformity.

Self-certification typically applies to:

• Consumer electronics (phones, laptops, audio equipment)
• General electrical equipment
• Most machinery (with some exceptions)
• Low-risk radio equipment
• Toys and general consumer products

When a Notified Body is required

Certain product categories require third-party assessment. You cannot legally self-certify these products—a Notified Body has to review your technical file and issue a certificate.

Notified Body involvement is mandatory for:

• Medical devices (most risk classes under MDR)
• Certain PPE categories (respiratory protection, fall protection)
• Pressure equipment above certain thresholds
• Some radio equipment categories
• Certain machinery with specific hazards

If you're unsure whether your product requires a Notified Body, a gap assessment early in the process can clarify the path forward and prevent surprises later.

Steps to get CE certification

Understanding the process helps you see what you're paying for at each stage.

1. Identify applicable directives and harmonised standards

First, determine which EU directives apply to your product based on what it does and how it's powered. Then find the relevant EN standards—these are the technical specifications that provide a "presumption of conformity" when followed correctly.

2. Conduct a gap assessment

Compare your current product and documentation against the requirements. This step identifies what testing is missing, what documentation gaps exist, and what changes might be needed before testing begins.

3. Prepare technical documentation

Compile the technical file: design specifications, schematics, risk assessment, test reports, user manual, and labeling. This documentation forms the evidence base for your compliance claim and stays with the product for its entire market life.

4. Complete required testing

Submit product samples to accredited laboratories for EMC, safety, and any product-specific tests. If failures occur, address the issues and retest. Test reports become part of your technical file.

5. Draft Declaration of Conformity and affix CE mark

The manufacturer or Authorised Representative signs the Declaration of Conformity (DoC). Then apply the CE marking to the product, packaging, or accompanying documentation as the directive requires.

How to reduce CE marking costs

Smart planning can cut costs without cutting corners. ~~Here are four approaches that consistently help teams save money.~~With manufacturers spending an average of $20,000 per employee annually on compliance, these four approaches consistently help teams save money.

Prepare documentation before engaging labs

Complete your technical file and fix obvious issues before testing begins. Lab rework and re-testing are expensive—first-pass success saves both time and money. A thorough internal review before submitting samples can prevent costly surprises.

Consolidate testing across directives

When possible, test for multiple directives in a single lab visit. This reduces shipping costs, setup fees, and administrative overhead. Coordinating with your lab upfront helps identify opportunities to combine tests.

Use compliance automation tools

AI-powered documentation tools turn technical inputs—BOMs, datasheets, CAD files—into compliance-ready outputs faster than manual preparation. This reduces consultant hours and catches gaps before they become expensive problems during testing or review.

Work with an integrated compliance partner

A single partner handling documentation, lab coordination, and representation reduces fragmentation. You avoid the hidden costs of managing multiple vendors, miscommunication between parties, and duplicated effort across workstreams.

Book a free call to see how an integrated approach can streamline your CE marking project.

Get predictable CE certification pricing with EcoComply

CE marking doesn't have to mean unpredictable costs and fragmented workflows. EcoComply combines AI-driven documentation automation with expert oversight, priority lab access, and EU/UK Authorised Representation—all in one platform.

Upload your technical inputs. Get compliance-ready outputs. Move faster with fewer surprises.

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