CE Marking: Your Electronic Product’s Passport to Europe

Posted on February 5, 2025 by Keith Cooper

If electrical products had passports, the CE mark would be their golden ticket to travel freely across Europe. But unlike that dusty old passport you forgot to renew, CE marking isn’t just a stamp—it’s a declaration of compliance with essential EU regulations.

So, whether you’re a manufacturer, importer, or someone who just really enjoys reading about regulatory compliance (we see you), let’s break down CE marking in an amusing, yet totally informative, way.

What Is CE Marking, and Why Should You Care?

CE marking is like a VIP badge for electrical products, proving that they meet the safety, health, and environmental protection standards set by the European Economic Area (EEA). Without it, your product is basically a tourist without a visa—good luck getting past customs!

If your electrical product isn’t properly marked, it can be:

🚨 Banned from being sold in Europe
⚖️ Subject to fines and legal action
🧐 Forcibly removed from the market (probably by a very stern regulatory officer)
💸 A costly mistake that could have been avoided

So, yeah, it’s a pretty big deal.

How Do You Get CE Marking? (A.K.A. The Compliance Treasure Hunt)

Earning CE marking isn’t as easy as slapping a sticker on your product and calling it a day. There’s a process—because, of course, there is. Here’s how it works:

1. Identify the Relevant Directives

The EU has a whole encyclopedia of directives and regulations, but for electrical products, the key players are usually:
⚡ Low Voltage Directive (LVD) – 2014/35/EU (for electrical safety)
📡 Electromagnetic Compatibility (EMC) Directive – 2014/30/EU (to avoid radio interference)

Radio Equipment Directive (RED) – 2014/53/EU – (for electrical/electronic products that intentionally emit and/or receives radio waves for purpose of radio communication)

 Machinery Directive (MD) – 2006/42/EC (for electrical and mechanical safety of machinery and partly completed machinery)
🌍 RoHS Directive – 2011/65/EU (to prevent harmful substances like lead and mercury)

You don’t need to memorize these (unless you really want to impress your compliance officer). Just know that your product must comply with the applicable ones.

2. Test Your Product Like a Mad Scientist

Once you know which rules apply, you need to prove that your product won’t explode, electrocute anyone, or cause mass WiFi disruption. This usually involves:

🔬 Lab testing to ensure electrical safety and electromagnetic compatibility
📜 Technical documentation (because the EU loves paperwork)
🏷 Labeling requirements (to make sure your CE mark is legit and not drawn in crayon)

3. Create a Technical File (A.k.a. Your Compliance Bible)

Think of this as your product’s “receipts” folder—it holds all the proof that your electrical product meets EU standards. It should include:

  • Test reports
  • Risk assessments
  • Design specifications
  • The EU Declaration of Conformity (basically a signed statement saying, “We promise this product won’t cause chaos”)

Pro tip: Keep this file for at least 10 years. You never know when a regulatory official might come knocking.

4. Affix the CE Mark Like a Pro

If your product passes all the necessary tests and audits, congratulations—you’ve earned the right to place that glorious CE mark on it! But beware:

✅ It must be visible, legible, and permanent
✅ It should follow the official proportions (don’t get creative with the font, please)
🚫 Fake or misleading CE marks can land you in legal hot water

Common CE Marking Myths (Busted!)

🤔 “CE marking means my product is approved by the EU.”
Nope! The EU doesn’t “approve” products. CE marking means you, the manufacturer, are declaring compliance.

🤔 “I can just put a CE sticker on my product and be done with it.”
Nice try! Without proper testing and documentation, that’s CE fraud, and trust us—you don’t want to be caught in that mess.

🤔 “CE marking is only for European companies.”
Not at all! If you sell electrical products in Europe—no matter where your company is based—you need CE marking.

Final Thoughts: CE Marking = Peace of Mind

Sure, compliance can feel like a bureaucratic nightmare, but CE marking isn’t just about ticking boxes—it’s about making sure your electrical products are safe, reliable, and legally marketable.

So, before you ship off that next batch of gadgets to Europe, take the time to get CE marking right. Your customers (and the EU regulators) will thank you.

Need help navigating the process? F2 Labs specializes in compliance testing and certification—so you don’t have to lose sleep over it. Let’s get your products CE-ready!  Please contact us at sales@f2labs.com or by phone at 877-405-1580 to get started right away.

Posted in ATEX Directive 2014/34/EU, CE marking, EMC Directive 2014/30/EU, General Product Safety Regulation (EU) 2023/988, GPSR, GPSR (EU)2023/988, Low Voltage Directive 2014/35/EU, Machinery Directive 2006/42/EC, Machinery Regulation (EU)2023/1230, Medical Devices Regulation (EU)2017/745, PPE Regulation (EU) 2016/425, Pressure Equipment Directive 2014/68/EU, Radio Equipment Directive 2014/53/EU, REACH, RoHS Directive 2011/65/EU | Comments Off on CE Marking: Your Electronic Product’s Passport to Europe

ECHA Adds Five New Substances to SVHC List

Posted on January 21, 2025 by Peter Jolles

The European Chemical Agency, ECHA, added five new substances to the list of Substances of Very High Concern (SVHC) overnight.

The EU’s SVHC list expanded from 242 to 247 today. These are potentially dangerous substances that carry EU reporting responsibilities if any individual part (or any part of any part) of your product contains > 0.1% of any of these substances.

This was expected and is the regular winter (December/January) REACH update. 2024 was interesting for REACH because there were three ECHA SVHC Updates. It increased to 240 in January, 241 in July, and 242 in November. Usually there are only two: one in the winter and one in the summer. The amount of susbtances can vary each time.

What does this mean for you?

You must prepare new SCIP dossiers within six months, every time the list updates, if you are continuing to build and ship equipment to the EU. Any SVHC content > 0.1% in any part of the build will require a submission to the SCIP database. REACH, along with the Waste Framework Directive, aka “WFD,” require reporting of these substances. But, these substances are not restricted from use.

F2 Labs can help you with this. We can take your bill of materials and put this on auto-pilot for you. Our REACH (and RoHS and Prop 65) compliance work, CE Certification Testing, and deliverable(s) free you and your colleagues from looking for full material declarations and then scouring that against the list of 247 substances for every part in your build. We format and load your BoM into our system and then we look for the documentation and we contact your suppliers directly on your behalf.

We deliver a formatted and correct I6Z data file, ready for you to deliver with your product to your customer in the EU.

CONTACT F2 LABS FOR HELP, THIS IS WHAT WE DO.

Want to discuss your project with us?

You can contact us at this link. Our phone number is 877-405-1580 and we are here to help you.

Posted in CE marking, Consulting, REACH, RoHS Directive 2011/65/EU | Comments Off on ECHA Adds Five New Substances to SVHC List

Does Customs Really Check For RoHS in The EU?

Posted on January 10, 2025 by Peter Jolles

Yes.

I get an email every week from the European Commission’s Safety Gate that lists some of the most dangerous products that were recently pulled from the market. These alerts are for products stopped in customs before they enter the market as well as products that passed customs but were later found to be non-compliant with one or more EU regulations.

The email arrives at about 8 or 9 PM EST every Thursday evening. And this week’s list of alerts contains a few products stopped for RoHS non-compliance. Below are three examples.

First up is Alert no. SR/00202/25. This electric toothbrush was discovered to have DEHP phthalates (1.7%), lead (0.34%), SCCPs (1.6%), and lead in solder as high as 61%. These substances are restricted to 0.1% per homogeneuos material, so, every little piece, even the individual bristles must comply.

This product has now been removed from the market, see below.

Next is Alert no. SR/00191/25. This is for a 12 VDC power supply that was caught with too many substances for me to list. Below is a picture of the power supply and then the reasons they stopped it.

Third is Alert no. A12/03293/24. The product is a wireless Bluetooth speaker. It has an FCCID and they claim it can be used in a shower – so presumably it has had IP Testing as well. As a compliance professional, that tells me that this product probably had a lot of testing and evaluation. It is a shame that someone’s marketing plans are ruined because one of the least expensive parts of the compliance process was overlooked.

It is interesting to note that they stopped this product for having leaded solder. There are some exemptions for lead – namely 7(a) that allows for the use of 85% lead in high-temperature solders. This is information you can glean during the design phase of your project by working with a compliance lab, like F2 Labs.

This is the current page for that product on Amazon.

CONTACT F2 LABS FOR HELP, THIS IS WHAT WE DO.

Want to discuss Product Safety Testing Service with us?

You can contact us at this link. Our phone number is 877-405-1580 and we are here to help you.

Posted in ATEX Directive 2014/34/EU, CE marking, Consulting, EMC Directive 2014/30/EU, Low Voltage Directive 2014/35/EU, Machinery Directive 2006/42/EC, Machinery Regulation (EU)2023/1230, PPE Regulation (EU) 2016/425, Pressure Equipment Directive 2014/68/EU, Product Testing, Radio Equipment Directive 2014/53/EU, REACH, RoHS Directive 2011/65/EU | Comments Off on Does Customs Really Check For RoHS in The EU?

Embracing AI in Healthcare: The FDA’s Guidance on Good Machine Learning Practice

Posted on September 30, 2024 by Keith Cooper

Embracing the Future: The FDA’s Guidance on AI in Medical Devices

As we enter an exciting era of technological advancement, the role of artificial intelligence (AI) in medical devices stands out as particularly transformative. The FDA’s recent guidance on “Good Machine Learning Practice” is a crucial milestone in steering this innovation, ensuring that the benefits of AI are realized alongside necessary safeguards.

Innovation Meets Responsibility

The potential of AI in healthcare is vast. We’re envisioning systems that can analyze medical images with remarkable speed and precision or predictive tools that flag patients at risk before any symptoms emerge. However, with such capabilities comes the need for careful oversight. The FDA’s guidance highlights the importance of solid scientific foundations in the creation of AI-based medical devices.

This guidance is more than a regulatory checklist; it encourages developers to engage in thorough design and rigorous evaluation. It prompts a consideration of the complexities inherent in healthcare environments, urging creators to reflect on how their AI technologies will function in practice and respond to diverse data inputs. The focus on “Good Machine Learning Practice” is a commitment to ensuring transparency, reliability, and accountability in these innovations.

Essential Principles

A central theme of the FDA’s guidance is the necessity for high-quality, diverse datasets. The success of AI tools hinges on the data they are trained with, meaning developers must prioritize representativeness to prevent bias—an increasingly important topic in discussions about ethical AI.

Additionally, the guidance underscores the significance of ongoing monitoring and adaptive learning. In a field where medical knowledge is constantly evolving, the ability of AI systems to update and improve over time is vital. This aspect can revolutionize patient care, allowing devices to learn from new information and enhance their effectiveness.

The Power of Collaboration

What stands out in the FDA’s approach is the emphasis on collaboration among all stakeholders—developers, healthcare professionals, and regulatory agencies. By working together, we can cultivate an environment that encourages innovation while prioritizing patient safety. This teamwork is essential in navigating the complexities associated with AI in medicine, ensuring we maximize the advantages of these technologies while mitigating potential risks.

Looking Forward

The FDA’s guidance on AI is more than a set of rules; it serves as a roadmap for the future of healthcare. As we harness the capabilities of machine learning, we must remain attentive to ethical considerations and patient outcomes.

As we anticipate the integration of AI into routine medical practices, let’s seize this chance to create a future where technology and healthcare collaborate seamlessly. While challenges will arise, a commitment to thoughtful regulation, high standards, and the support of Medical Device Testing Labs can help us navigate this exciting landscape together.

CONTACT F2 LABS FOR HELP, THIS IS WHAT WE DO.

Want to discuss your project with us?

You can contact us at this link. Our phone number is 877-405-1580 and we are here to help you.

Posted in EN 60601-1, FDA, Medical Devices Regulation (EU)2017/745 | Comments Off on Embracing AI in Healthcare: The FDA’s Guidance on Good Machine Learning Practice

What is an NRTL Field Label and What do I Need to Know About Them?

Posted on September 12, 2024 by Keith Cooper

If an Authority Having Jurisdiction (AHJ) or electrical inspector has ever informed you that you have failed your inspection or that you require a “UL or CSA Certification” or that your equipment must be “UL/CSA Certified” or “UL/CSA Labeled” we can help you. F2 Labs can provide the evaluation, testing, and label you need to turn the equipment on and turn it over to your customer – and move on to the next project. 

When someone says, “UL or CSA Certification” or that your equipment be “UL/CSA Certified” or “UL/CSA Labeled”, that means your product must be evaluated to meet the government guidelines for installation and use of the equipment at that location.  In these instances, the AHJ or inspector is asking for you to have your equipment “Field Labeled” by an OSHA approved NRTL (National Recognized Testing Laboratory) and is not asking you to specifically have Underwriters Laboratories (UL) or CSA Group (CSA) perform the evaluation.  There are many different labs that can certify products to the UL and CSA standards.  You have the freedom to use a different laboratory in almost all cases.

If you have a piece of equipment that is unlabeled and it is preventing you from starting production on your line or turning the equipment over to your customer at their site, F2 Labs can quickly quote and schedule our engineers to get you exactly what you need to get moving. We have three locations in the in the US from which to dispatch our experienced Safety Engineers to perform the UL Certification & CSA International Certification testing quickly. Additionally, we collect information from you and review it prior to our visit to reduce inefficient and costly second visits.

CONTACT F2 LABS FOR HELP, THIS IS WHAT WE DO.

Want to discuss your project with us?

You can contact us at this link. Our phone number is 877-405-1580 and we are here to help you.

Posted in Field Label, Product Testing, SPE-1000, US Field Label | Comments Off on What is an NRTL Field Label and What do I Need to Know About Them?

The FDA and Common Electromagnetic (EM) Emitters – What You Need to Know

Posted on August 23, 2024 by Keith Cooper

The FDA, per their Guidance Document published June 6, 2022, requires that medical device manufacturers be able to show that their product is immune to common Electromagnetic (EM) Emitters, such as RFID Readers, Near-field Communication (NFC) systems, metal detectors, Electronic Article Surveillance (EAS), Wireless Power Transfer (WPT), 5G Cellular, electrocautery, MRI, diathermy and electrosurgical devices.  The technologies that these devices use are not covered under IEC 60601-1-2.

F2 Labs has developed EMI & EMC testing methods that are accepted by the FDA to demonstrate medical devices are safe in regard to Common Electromagnetic (EM) Emitters that are foreseeable in the intended use environment, and in some areas where you may not even realize that these technologies are present.

CONTACT F2 LABS FOR HELP, THIS IS WHAT WE DO.

Want to discuss your project with us?

You can contact us at this link. Our phone number is 877-405-1580 and we are here to help you.

Posted in FDA, Product Testing | Comments Off on The FDA and Common Electromagnetic (EM) Emitters – What You Need to Know

Easy Approach to Essential Performance in Medical Devices for FDA

Posted on August 15, 2024 by Cristina Akinwale

F2 Labs has many conversations every week with medical device manufacturers who are struggling to define Essential Performance for their device.

 
From our experience, the confusion around Essential Performance frequently stems from the fact that what a device manufacturer views as ‘essential performance’, does not align with the definition of ‘Essential Performance’ from IEC 60601-1.
 
They consider every function described by the product’s specification to be ‘essential’.  If the device does not work as intended – what is the point?  Who would want to buy or use it?   These specifications will need to be proven through bench testing typically performed by the manufacturer, on the manufacturer’s behalf by an accredited Medical Device Testing lab.  However – this is not the same as what 60601-1 intends when it defines Essential Performance.    
 
For the purposes of 60601 testing, the definition Essential Performance is this:

Essential Performance: those clinical functions which ‘if degraded or not present, could result in an unacceptable risk’.   

 Blending the two ideas of essential performance together muddies the waters, and often creates confusion in developing the correct Essential Performance for a device.


 Defining Essential Performance can be simplified by breaking it down into manageable pieces as follows:
 
1. Create a list of your device’s clinical functions (there could be one, none, or many).
2. Review each one individually and ask “If this function is not performing correctly (inaccurately or at all), could it result in an unacceptable risk?”


(a) If the answer is no, that particular function is not Essential Performance.
(b) If the answer is yes, that particular function is Essential Performance.


3. For each item that was answered ‘Yes’, define the exact requirement and define the method of monitoring.
 
That’s it – you could end up with one, none, or many. The rationale you use for making these decisions should be detailed in your Risk Management File.

Let’s follow the above steps using the simple example of a basic thermometer.
 
1. List of clinical functions:

(i) Measure temperature accurately.
(ii) Display that measurement on a cell phone app.

2. Review each clinical function individually, and ask the question – is this Essential Performance?

(i) Measure temperature accurately:

Yes – treatment decisions will be made based on this measurement (i.e. administer medication)    

(ii)  Display that measurement on a cell phone app:

No – if the result is ‘unavailable’, a different thermometer could be used, no treatment decisions would be made, etc.

3. For each item that was answered ‘Yes’, define the exact requirement and define the method of monitoring it.

(i) Measure temperature accurately.                     

(a) Define the exact requirement(s):  measure temperature within +/-  0.10 degrees                           
(b) Define the method of monitoring/measuring: use a calibrated thermometer or calibrated water bath to verify the measurement accuracy.

In this example, the Essential Performance and Method of Monitoring for this thermometer is:

 CONTACT F2 LABS FOR HELP, THIS IS WHAT WE DO.

Want to discuss your project with us?

You can contact us at this link. Our phone number is 877-405-1580 and we are here to help you.


                            

Posted in FDA | Comments Off on Easy Approach to Essential Performance in Medical Devices for FDA

IEC 60601-1-9 Environmentally Conscious Design – What is it?

Posted on August 14, 2024 by Keith Cooper

What exactly is the environmentally conscious design file?  You need documentation/policies that show how you are addressing the requirements of that standard.  You really should use the standard as guidance (IEC 60601-1-9).  Here is some good information on what this standard covers.  Note – you must have documentation – but it does not have to be fancy or complicated, it can be ‘simple’.

IEC 60601-1-9 addresses the environmental aspects of medical electrical equipment. Its primary purpose is to guide manufacturers in designing medical devices that are environmentally conscious throughout their lifecycle.

Key Purposes of IEC 60601-1-9:

  1. Environmental Impact Reduction:
  2. It focuses on reducing the environmental impact of medical devices, including energy consumption, resource use, and waste production, during the design, manufacturing, usage, and end-of-life phases.
  3. Life-Cycle Assessment:
  4. The standard encourages the consideration of the entire life cycle of the product, from raw material extraction to disposal, ensuring that environmental impacts are minimized at each stage.
  5. Sustainability:
  6. It promotes the use of materials and processes that are less harmful to the environment, such as reducing hazardous substances and increasing the recyclability of the equipment.
  7. Compliance and Certification:
  8. Compliance with IEC 60601-1-9 can, which can be facilitated by Medical Device Testing Labs, be necessary for regulatory approvals in certain markets, and it demonstrates a commitment to sustainable practices in medical device manufacturing.

Is this a mandatory requirement?  This is a mandatory requirement coming from Brazil.

For the RMF, can we substitute it with our existing risk management file?  Yes, these are the same thing.

Summary:

IEC 60601-1-9 is intended to ensure that medical electrical equipment is designed with environmental considerations in mind, promoting sustainability and reducing the ecological footprint of these devices.

CONTACT F2 LABS FOR HELP, THIS IS WHAT WE DO.

Want to discuss your project with us?

You can contact us at this link. Our phone number is 877-405-1580 and we are here to help you.

Posted in CE marking, EN 60601-1, IEC 60601-1-9, Medical Devices Regulation (EU)2017/745 | Comments Off on IEC 60601-1-9 Environmentally Conscious Design – What is it?

Navigating CE Certification for Entry Into the European Market

Posted on July 19, 2024 by outerboxseo

As both established and startup consumer electronics manufacturers look to expand their market reach, the European Union presents an enticing, lucrative growth opportunity. Entry into this market comes with its prerequisites, however, one of which is CE certification testing. This certification is a regulatory mark that signifies a product’s compliance with EU legislation, primarily focusing on health, EMC, safety, and environmental protection. Products ranging from electrical equipment to toys to medical devices all require CE certification to be sold within the European market.

CE certification is more than just a sticker on your product; it’s a passport for your products’ arrival into the European Union. It applies to a broad range of goods, including consumer electronics, machinery, and medical devices. CE certification upholds basic principles of health, safety, and environmental protection, ensuring that products sold within the EU do not compromise the well-being of its users or the environment.

Understanding the CE marking process and ensuring compliance is pivotal for manufacturers aiming for market entry, as it not only facilitates smoother customs clearance but also boosts consumer confidence in product safety and standards.

The EU flag waving atop a European building

The CE Certification Process: A Step-by-Step Guide

Navigating the CE certification process requires meticulous attention to detail and a thorough understanding of the European Union’s regulatory environment. Before a product can proudly display the CE mark, manufacturers must embark on a multi-faceted journey that begins with identifying the specific legal frameworks applicable to their product. This initial stage lays the groundwork for the entire certification process, underscoring the necessity for precision and expertise in regulatory compliance.

1. Identifying Relevant EU Directives and Standards: The first step in obtaining CE certification is to identify which specific EU directives and harmonized standards apply to your product. This involves a detailed analysis of your product’s features and functionalities to match them with the relevant legal requirements.

2. Assessing Product Compliance: Once the applicable directives are identified, manufacturers must assess whether their product complies with these requirements. This can be done through self-assessment or by engaging third-party CE certification services, which can provide an unbiased evaluation of your product’s conformity.

3. Technical Documentation: Compiling comprehensive technical documentation is a critical step in the CE certification process. This documentation should provide evidence of compliance with the relevant directives and standards, including design, manufacture, and operation details. It serves as a dossier that demonstrates your product’s eligibility for the CE mark.

4. CE Marking and Declaration of Conformity: After ensuring compliance and compiling the necessary documentation, manufacturers can then affix the CE mark on their products. Alongside this, a Declaration of Conformity must be drafted, declaring that the product meets all the relevant requirements. This declaration must be available to the European authorities upon request.

Challenges and Solutions in Obtaining CE Certification

Manufacturers often face challenges such as navigating the complex landscape of EU directives, ensuring accurate product classification, and managing the comprehensive documentation required for compliance. A practical solution is to leverage the expertise of CE certification services, which can guide you through the intricacies of the process, from initial assessment to the final declaration. Engaging with these services early in the product development phase can mitigate risks and streamline the path to compliance.

CE certification is a crucial milestone for manufacturers aiming to enter the European market. It not only ensures that products adhere to high safety, EMC, health, and environmental standards but also opens the door to a vast and diverse marketplace. By integrating compliance into the early stages of product development and utilizing the expertise of CE certification services, manufacturers can navigate the certification process more efficiently, avoiding common pitfalls and accelerating market entry.

Let F2 Labs be your guide to success in the European market, ensuring that your products are welcomed by consumers and regulators alike.

CONTACT F2 LABS FOR HELP, THIS IS WHAT WE DO.

Want to discuss your project with us?

You can contact us at this link. Our phone number is 877-405-1580 and we are here to help you.

Posted in ATEX Directive 2014/34/EU, CE marking, Consulting, EMC Directive 2014/30/EU, Low Voltage Directive 2014/35/EU, Machinery Directive 2006/42/EC, Machinery Regulation (EU)2023/1230, Medical Devices Regulation (EU)2017/745, Pressure Equipment Directive 2014/68/EU, Radio Equipment Directive 2014/53/EU, RoHS Directive 2011/65/EU | Comments Off on Navigating CE Certification for Entry Into the European Market

Reese’s Law – What You Need To Know

Posted on July 3, 2024 by Keith Cooper

Reese’s Law was signed by President Biden on August 16, 2022 and as of March 19, 2024 all products that incorporate button batteries or coin cell batteries must comply with UL certification 4200A as the safety standard for performance and labeling per 16 CFR 1263.  The intent of this law is to reduce the risk of injury from the ingestion of button cell or coin cell batteries by children six years or younger. 

Per UL 4200A products that contain these battery types or are designed to use these battery types must:

  • Have compartments that hold such batteries be secured such that they require a tool or at least two independent hand movements to open
  • These compartments cannot be accessed or the batteries contained therein accessed as a result of repeated use and abuse
  • The packaging must contain a warning label
  • The product itself must contain a warning label
  • Manuals and instructions must include all applicable warnings.

F2 Labs can assist in the required testing necessary to comply with Reese’s Law.  Reach out to us today to begin a discussion with one of our technical sales staff to guide you through the process.

CONTACT F2 LABS FOR HELP, THIS IS WHAT WE DO.

Want to discuss your project with us?

You can contact us at this link. Our phone number is 877-405-1580 and we are here to help you.

Posted in Listing, Product Testing, UL 4200A | Comments Off on Reese’s Law – What You Need To Know