Unregulated Certificates Warning and The Implications Under EU Law

Recently, the European Commission updated some of the guidance regarding the EMC, ATEX, and Low Voltage Directives (and others) to include a warning about unregulated certificates.

The warning explains that voluntary certificates issued by certification bodies not designated as notified bodies under EU law are misleadingly presented for products subject to EU harmonization legislation. A notified body is an organization designated with special credentials by one or more countries in the EU to assess the conformity of products before they are placed on the market. In most cases (almost all) you do not need a Notified Body.

These certificates are not recognized as proof of compliance. Only notified bodies can issue EU type-examination certificates for products and only for product types for which they are listed under NANDO (New Approach Notified and Designated Organizations). Harmonized standards demonstrate that products, services, or processes comply with EU legislation.

Some third-party certifications are misleadingly labeled with terms like “certification” or “certificate,” like the certificate example included below. They are labeled with a CE marking but in this context the CE marking is meaningless.

A device cannot carry a CE marking if it does not meet the requirements of the RoHS directive. RoHS is one of the legal directives a product must conform to bear the CE marking.

The guidance on the referenced European Commission sites indicates that the EU is cracking down on these. The certificate below holds no legal weight, every CE marking Directive requires, with no exceptions, an EU declaration of conformity to be available with the product if the product warrants a CE marking. No EU declaration of conformity, no CE marking. There is no half-measure.

Certificates like these can be deceptive. They look legitimate but are invalid as pertains any claim of CE marking compliance and could potentially stop your product in customs or by market surveillance authorities. The European Commission is clear about these documents; these “certificates” are not recognized as proof of compliance.

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, EMC Directive 2014/30/EU, Low Voltage Directive 2014/35/EU | Tagged , , , , , , | Comments Off on Unregulated Certificates Warning and The Implications Under EU Law

Is Machinery in Scope of the RoHS Directive?

My machine is industrial machinery, do I have to comply with RoHS for CE marking?” We are frequently asked this question. The answer is – yes, unless you fall into one of the exclusions available from the RoHS Directive 2011/65/EU. We will pull this apart in this following article.

Let’s take it from the top. The RoHS Directive 2011/65/EU is for the Restriction of Hazardous Substances… colloquially known as “RoHS”. Pronounced “Ross” or “ROH-hass”. The RoHS Directive applies to anything with any electric or electronic function.

First, let’s define what is in scope and then we will look at the exclusions. RoHS is applicable per Article 2, 1:

This Directive shall, subject to paragraph 2, apply to EEE falling within the categories set out in Annex I.

See the list from Annex I:

  1. Large household appliances.
  2. Small household appliances.
  3. IT and telecommunications equipment.
  4. Consumer equipment.
  5. Lighting equipment.
  6. Electrical and electronic tools.
  7. Toys, leisure and sports equipment.
  8. Medical devices.
  9. Monitoring and control instruments including industrial monitoring and control instruments.
  10. Automatic dispensers.
  11. Other EEE not covered by any of the categories above.

Then – let’s see what “EEE” means. See the definition in Article 3, (1):

‘electrical and electronic equipment’ or ‘EEE’ means equipment which is dependent on electric currents or electromagnetic fields in order to work properly and equipment for the generation, transfer and measurement of such currents and fields and designed for use with a voltage rating not exceeding 1 000 volts for alternating current and 1 500 volts for direct current;

Summary – if your equipment has any electric or electronic function and it matches any of the equipment listed in Annex I… you are in scope and must comply with the RoHS Directive. This means that every single part of your build must meet the substance level restrictions indicated in Annex II (Note: Annex II was updated by Commission Delegated Directive (EU) 2015/863):

ANNEX II
Restricted substances referred to in Article 4(1) and maximum concentration values tolerated by weight in homogeneous materials
Lead (0,1 %)
Mercury (0,1 %)
Cadmium (0,01 %)
Hexavalent chromium (0,1 %)
Polybrominated biphenyls (PBB) (0,1 %)
Polybrominated diphenyl ethers (PBDE) (0,1 %)
Bis(2-ethylhexyl) phthalate (DEHP) (0,1 %)
Butyl benzyl phthalate (BBP) (0,1 %)
Dibutyl phthalate (DBP) (0,1 %)
Diisobutyl phthalate (DIBP) (0,1 %)
…’

The machinery above is in scope of RoHS, unless we can fit it into an exclusion. For the purposes of this article, assume it is in scope. What this means for this build is that every single part and every single piece of every part must comply with the substance restrictions identified in Annex II above. This means the blue and orange plastic, the screws, the cutting blade, housing, tool head, and every piece inside the housing (the board and all of its components) must individually comply with the restriction levels for the above ten identified substances.

Next, we will look at the exclusions dealing with large equipment. Depending upon your equipment – you may or may not be able to exclude it as ‘large-scale”. It depends on a few factors, including how large your equipment is and how large the final installation to which it will be fitted is, and how ‘custom’ your build is.

See RoHS 2011/65/EU, Article 2, 4., (c), (d), and (E):

This Directive does not apply to:

(c) equipment which is specifically designed, and is to be installed, as part of another type of equipment that is excluded or does not fall within the scope of this Directive, which can fulfil its function only if it is part of that equipment, and which can be replaced only by the same specifically designed equipment;
(d) large-scale stationary industrial tools;
(e) large-scale fixed installations;

OK, first let’s key in on (d) and (e) and what they really mean. See the definitions in Article 3, (3) and (4):

3) ‘large-scale stationary industrial tools’ means a large-scale assembly of machines, equipment, and/or components, functioning together for a specific application, permanently installed and de-installed by professionals at a given place, and used and maintained by professionals in an industrial manufacturing facility or research and development facility;

(4) ‘large-scale fixed installation’ means a large-scale combination of several types of apparatus and, where applicable, other devices, which are assembled and installed by professionals, intended to be used permanently in a pre-defined and dedicated location, and de-installed by professionals;

Next we see consider the two above definitions against Article 2, 4., (c) – defined above and summarized as equipment specifically designed for and permanently mounted to an excluded category of equipment… like large-scale stationary industrial tools and large-scale fixed installations. This does not mean that you can exclude your small device if it can be fitted to any large scale equipment. It means it can be excluded if your small device is custom made for a specific application (one machine, meaning… one unit) that is also excluded. If you make a thermostat that can be fitted to different HVAC systems you are unable to use the Article 2, 4., (c) exclusion. But, if you custom design a thermostat for a very large HVAC system that is custom made for a building or factory… and it is only made for that particular installation then, yes, it can be excluded.

But, what about larger equipment? The European Commission published very specific guidance about this in 2012 and it is still the reference material. That guidance is available at the Euorpean Commission’s RoHS page, here.

Download the FAQ at the link. The document you want is on that web page as a direct download link indicated by the green arrow above. The entire document is worth reading but for this article we want to look at the specific guidance in Section 3. Scope – Large-scale Exclusions starting on page 9. Section 3 elaborates on criteria for large-scale exclusions on page 11, see below:

One possible way of introducing a direct size criterion relates to transportation. The following guidance metrics and qualitative criteria can be applied for installations. If the installation exceeds the minimum requirements for one of the following criteria, it can be considered large-scale:

  • If, when installing or de-installing the installation, it is too large to be moved in
    an ISO 20 foot container because the total sum of its parts as transported is
    larger than 5,71m x 2,35m x 2,39m, it can be considered large-scale.
  • The maximum weight of many road trucks is 44 tonnes. Thus if, when installing
    or de-installing the installation, it is too heavy to be moved by a 44 tonne road
    truck, because the total sum of its parts as transported weighs more than the
    truck’s load capacity, it can be considered large-scale.
  • If heavy-duty cranes are needed for installation or de-installation, the
    installation can be considered large-scale.
  • An installation that does not fit within a normal industrial environment, without
    the environment needing structural modification, can be considered large-scale.

    Examples for modifications are modified access areas, strengthened
    foundations etc.
  • If an installation has a rated power greater than 375 kW, it can be considered
    large-scale.

    This is only an indicative list.

If your equipment can fit in one tractor trailer load then it is in scope. If your equipment can fit in a 20-foot ISO container it also is in scope. See the truck below. Can your device fit in it when it is crated up? You are in scope and must comply if the answer is yes. In fact, just placing a CE marking on your machine is a claim of compliance to RoHS, if it is in scope. There are penalties for non-compliance. In the case of RoHS especially, compliance is much less expensive than the penalties. In almost all RoHS projects at F2 Labs we are able to get through the evaluation with a positive conclusion (compliant EN 63000:2018 report) and without testing.

Finally, see also Q6.3 from the linked RoHS guidance document below:

Q6.3 Does RoHS 2 apply to EEE for professional and industrial use?
Yes. RoHS 2, just as RoHS 1, does not distinguish between EEE for consumer use and EEE for professional and industrial use. In some cases however specific exclusions (Article 2(4)) or timelines (Article 4(3), 4(4) and 4(5)) may apply.

Our advice is that if you cannot exclude your equipment per the above, you are in scope.

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

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, International Testing, 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, Product Testing, Prop 65, Radio Equipment Directive 2014/53/EU, REACH, RoHS Directive 2011/65/EU | Comments Off on Is Machinery in Scope of the RoHS Directive?

Taming the EMC Beast: A Guide to Pre-Compliance Testing

Ah, the thrilling world of electromagnetic compatibility (EMC) testing! If you’ve ever dreamed of spending quality time with spectrum analyzers and line impedance stabilization networks (LISNs), you’re in for a treat. Let’s embark on a whimsical journey through the essentials of pre-compliance testing for your AC-powered gadgets or DC-powered gadgets that get that power from an AC/DC power supply, inspired by the wisdom of seasoned EMC professionals.

Setting the Stage: Your Test Setup

Picture this: your device under test (DUT) is lounging on a non-conductive table, probably contemplating its existence. Nearby, a spectrum analyzer eagerly awaits, ready to unveil the secrets of your device’s emissions. The LISN stands guard, ensuring that the power line impedance behaves itself. And let’s not forget the ground plane—whether it’s a fancy metallic sheet or a humble piece of heavy-duty aluminum foil, it’s there to catch any stray noise currents trying to escape.

The Usual Suspects: Common Mode and Differential Mode Noise

In the EMC detective story, two culprits often emerge: common mode (CM) and differential mode (DM) noise. CM noise is like that uninvited party guest who sneaks out through both the line and neutral wires, while DM noise is the bickering between the two wires themselves. Identifying which one is causing trouble is crucial for applying the right noise suppression tactics.

The Plot Thickens: Filtering Out the Noise

Without any filters, your DUT might be broadcasting its own radio station, much to the dismay of EMC standards. Introducing a filter board can act like a charm school, teaching those unruly emissions some manners. For instance, adding a filter designed for 150 kHz to 30 MHz can reduce noise by an average of 10 dB. But why stop there? Throwing in a pair of 100 µH inductors in series can further discipline those emissions, achieving reductions up to 30 dB. It’s like sending your emissions to a strict boarding school—they’ll come back transformed.

The Grand Finale: Why Bother with Pre-Compliance Testing?

Embarking on pre-compliance testing is like rehearsing before the big performance. It allows you to catch those off-key notes early, saving you from embarrassing failures during the official compliance test. Plus, it saves time and money—two things every engineer loves. So, embrace the process, and may your devices pass with flying colors (or at least within acceptable emission limits).

Remember, EMC testing doesn’t have to be a dry, monotonous task. With a bit of humor and the right approach, you can turn it into an electrifying adventure. Happy testing!

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

Would you like us to help you craft a pre-compliance plan for your new product?

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

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Prop 65 Alert: New Chemical Found in Plastics, Packaging and Paints

In January, a new chemical was added to the California Proposition 65 list. Vinyl Acetate was found to cause cancer and has been detected in food packaging, building materials, and contaminated air or soil.

Let’s break this down:

  • Vinyl acetate is found in polymers which are used in glues, paints, and coatings
  • It is a component of plastics and resins
  • Vinyl acetate is used in food packaging, product packaging, and acrylic fibers
  • It is also found in wire, cable compounds, and safety glass

The list goes on. The Office of Environmental Health Hazard Assessment has released a public notice that details the Evidence on the Carcinogenicity of Vinyl Acetate.

A Proposition 65 warning is only required for parts that can be touched by users and maintenance personnel. If Vinyl acetate is found, for example, in paint on the outside of a product, it can be touched.

At F2 Labs, we research every component of your build that can be touched. We then determine whether a Proposition 65 warning is required, and in most cases, it is. You don’t want to be fined thousands a day for not doing your due diligence.

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 Prop 65, REACH, RoHS Directive 2011/65/EU | Tagged , , | Comments Off on Prop 65 Alert: New Chemical Found in Plastics, Packaging and Paints

So You Need a Field Evaluation?

So, you’ve just had the pleasure of hearing from an Authority Having Jurisdiction (AHJ) or an electrical inspector, and their message was something along the lines of: “You’ve failed your inspection!” or “Your equipment needs a ‘UL or CSA Certification!’” Or maybe they dropped the “UL/CSA Certified” or “UL/CSA Labeled” bomb on you. Don’t panic! We’ve got you covered. Whether it’s a UL or CSA sticker, a fancy certification, or just a quick “You’re good to go!” stamp, we’re here to make sure you can flip that switch, fire up the equipment, and move on to the next project without breaking a sweat.

Now, let’s break down what those “UL” and “CSA” terms actually mean. When someone drops “UL or CSA Certification” into a conversation, what they’re really asking is that your equipment undergoes a little makeover to meet those lovely government guidelines for installation and use. The AHJ or inspector isn’t specifically demanding Underwriters Laboratories (UL) or CSA Group (CSA) to do the honors, but they do want your gear to get a golden ticket from an OSHA-approved NRTL (National Recognized Testing Laboratory). That means you can choose from a smorgasbord of labs to get your equipment certified to meet UL and CSA standards. So, no need to get married to just UL or CSA — you’ve got options, my friend!

If your equipment is currently going through a mid-life crisis and has no label (aka the dreaded “unlabeled equipment” status), leaving you stuck in production limbo and unable to hand over your shiny new machine to your customer, fear not! F2 Labs is here to save the day. We’ll whip up a quick quote and send out our skilled engineers faster than you can say “Field Labeled.” We have three handy U.S. locations ready to deploy our Safety Engineers at lightning speed. And, because we’re pros, we’ll gather all the info we need from you beforehand, so we don’t waste time (or your money) with unnecessary second visits.

Bottom line: You handle the work, we’ll handle the certification. Let’s get that gear labeled and let you get back to the important stuff — like counting all the cash you’re going to make now that your equipment is up to code.

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, Field Label, SPE-1000, US Field Label | Comments Off on So You Need a Field Evaluation?

How to Navigate California Proposition 65

Almost anything being sold in California may require a Proposition 65 warning. Proposition 65 is a California law titled the Safe Drinking Water and Toxic Enforcement Act. The law was put in place to protect consumers and notify them if the product contains hazardous chemicals.

The Prop 65 list identifies 900+ risk categories, and the manufacturer must identify parts listed for male and female reproductive harm, cancer, and mutagenic (birth defects) risks. Prop 65 is only required for parts that can be touched by users or maintenance personnel.

Prop 65 applies to products sold or distributed in California. It does not matter where the product is manufactured – if it ends up in California, Prop 65 applies. Law firms can and do send staff down aisles at stores and wipe parts of a product that can be touched. This is called a “wipe test.” If they wipe something in the store and it comes up with Prop 65 substances in it, and it has no corresponding warning for the substance detected, they will send it out for testing. The manufacturer can be fined up to thousands daily, per occurrence, until the product has been removed from the market, or a warning label is placed.

Companies must warn users if their products contain any of these 900+ substance risks. If your product does not contain any such substances, there is no need to include a warning, but you must be sure. The warning label must be placed on the product. A warning may be placed on the packaging if the product is too small to carry a label.

F2 Labs can assist with a Prop 65 evaluation and in almost all cases we get through it without testing.

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 Prop 65, REACH, RoHS Directive 2011/65/EU | Tagged , , | Comments Off on How to Navigate California Proposition 65

Breaking Down California’s New Proposition 65 Labeling Guidelines

The Office of Environmental Health Hazard Assessment published regulatory changes to the short-form warning label requirements in 2025. The changes will affect the short-form label requirements, including limitations on when they can be used, updates to the required language, and strict formatting guidelines.

Because of the stricter requirements, companies must investigate their supply chains to identify whether their products or components contain chemicals listed under Proposition 65.

Previously, short-form warning labels allowed a simplified format with a generic warning statement, “WARNING: Cancer, Developmental Toxicity, Male Reproductive Toxicity, & Female Reproductive Toxicity – www.P65Warnings.ca.gov.” The new short-form warning must include at least one chemical name associated with the risk being disclosed, “WARNING: This product can expose you to Lead, which is known to the State of California to cause Cancer, Developmental Toxicity, Male Reproductive Toxicity, & Female Reproductive Toxicity. For more information, visit www.P65Warnings.ca.gov.”

The new regulations became effective on January 1, 2025. There will be a three-year grace period, which ends on December 31, 2027. Products manufactured before January 1, 2025, may continue using the old warning labels if they meet the previous compliance standards. Businesses must demonstrate that the products were manufactured before January 1, 2025, and the warnings applied followed the prior regulations.

Starting January 1, 2028, full compliance with the new regulations will be mandatory, regardless of the manufacturing date. All products offered in California must display the updated short-form warnings and meet the revised content, format, and visibility standards.

Example below:

WARNING: Risk of developmental toxicity from exposure to Cycloheximide. See www.P65Warnings.ca.gov

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, Prop 65 | Tagged , , , | Comments Off on Breaking Down California’s New Proposition 65 Labeling Guidelines

The Wacky World of Exempted Devices: What You Don’t Need to Worry About

Ever wonder what kind of electronic devices the government just lets off the hook? No, it’s not your phone, though that would be nice, right? The Federal Communications Commission (FCC) has a special list of devices that don’t need to follow all the usual radio-frequency rules. Here’s the rundown on the exempted devices from Section 15.103:

  1. Vehicles and Aircraft: If you’re cruising around in a car or flying high in a plane, any digital device you use while doing that is exempt. That means your in-car entertainment system? Free to roam. However, if you can take that digital device out of the vehicle or aircraft and use it elsewhere – Part 15 applies.
  2. Utility Control Devices: Public utilities get a pass too! Their power systems, typically found in buildings or huge industrial spaces, don’t have to worry about specific tech standards.
  3. Test Equipment: Got some specialized test gear for your job? Whether it’s industrial, commercial, or medical, as long as it’s for testing, you’re off the hook for Part 15 – but may need to consider Part 18 instead.
  4. Appliance Devices: Your microwave, dishwasher, or clothes dryer? FCC Part 15, subpart B does not apply – unless they contain a wireless transmitter (i.e., Wi-Fi, Bluetooth, BLE, etc.).
  5. Medical Devices: Certain specialized medical devices (as long as they’re being used properly and under a doctor’s supervision) that don’t use wireless transmitters are good to go, however there may be requirements under 60601-1-2 that need to be considered.
  6. Low Power: Any device using less than 6 nanowatts of power is too tiny to bother with.
  7. Simple Input Devices: Joysticks and mice that don’t involve wireless transmission? They’re just chillin’ on the exempt list, too.
  8. Digital Devices Operating under 1.705MHz: Devices that do not operate from AC Power – but guess what – if your device pulls power from a wall outlet, or another device (computer, AC/DC adaptor, etc.) that plugs into a wall outlet to power the device or charge it – Part 15 applies.

Don’t mess with anything that causes interference, or you’ll be asked to stop until it’s fixed, and fines can be hefty. But hey, no pressure!

Contact F2 Labs if you’re confused about the FCC Part 15 requirements.  We’ll be happy to provide you with guidance so you can make an informed decision.

Posted in FCC | Comments Off on The Wacky World of Exempted Devices: What You Don’t Need to Worry About

Cracking the Code: How to Survive the FDA’s AI-Enabled Medical Device Guidance and Maintain Your Sanity

Buckle up, folks—our favorite regulatory sheriffs at the FDA have dropped another massive rulebook, this time titled “Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations.” If you’re still awake after reading that title, congratulations! This document is essentially a roadmap for manufacturers navigating the treacherous waters of AI-powered medical devices, ensuring these gadgets don’t turn into rogue robots making wild medical decisions.

The Big Idea: The Total Product Life Cycle (TPLC) Approach

The FDA is obsessed with this Total Product Life Cycle (TPLC) concept, which basically means manufacturers should keep an eye on their AI medical devices forever—from conception to post-market babysitting. This makes sense because AI has a mind of its own (almost), evolving over time like that one houseplant you keep forgetting to water. The guidance helps companies make sure their devices stay safe, effective, and don’t decide to randomly diagnose everyone with the plague.

The FDA’s Cheat Sheet for AI Device Manufacturers

Here’s what the FDA wants you to do (besides reading their 50-page document without crying):

Build a Quality Fortress 🏰

Document everything. No, seriously. The FDA wants meticulous records of your design, development, and maintenance phases so they can check if you’ve done your homework. Think of it as keeping receipts—because if something goes wrong, they will ask for them.

Describe Your Brainy Device 🤖

The FDA expects you to spell out exactly what your AI-powered marvel does, how it does it, and why. They’re not impressed with vague descriptions like “It just works.” So, be transparent about its purpose, the AI models it uses, and how it makes its life-changing (or mildly useful) decisions.

User-Friendly or Bust 🎛️

Ever used a product so confusing that you wanted to throw it out the window? The FDA doesn’t want that happening with life-saving devices. Clear labeling, intuitive design, and interfaces that don’t require a PhD to operate are a must.

Sniff Out the Risks 🚨

AI can be a bit of a wildcard, so manufacturers need to conduct risk assessments to ensure their devices aren’t accidentally introducing new hazards. Basically, figure out all the ways your AI could go rogue before it does.

Manage That Data Like a Pro 📊

AI feeds on data like a hungry teenager, but not all data is good data. The FDA insists on strong data management, ensuring that datasets are diverse, secure, and not riddled with errors that could make the device biased or ineffective.

Keep an Eye on It (Forever) 👀

Just because your device got FDA approval doesn’t mean you can ignore it. The agency wants manufacturers to set up post-market performance monitoring—because AI loves to learn and change, and sometimes, it learns the wrong things.

Bias Alert: AI’s Not-So-Secret Flaw

One of the biggest takeaways? AI can be super biased. If a device is trained on limited data, it might work great for some people and be completely useless (or even dangerous) for others. The FDA is nudging manufacturers to catch and fix these biases before their AI devices start playing favorites.

FDA’s Golden Advice: Talk to Us Early

Rather than surprising the FDA with an AI medical device they’ve never seen before (not recommended), manufacturers should chat with them early in the process. Think of it as showing your teacher a rough draft before turning in the final essay—this can help avoid unpleasant surprises later.

Final Verdict

The FDA’s latest guidance provides a structured game plan for AI-enabled medical devices, ensuring they’re safe, effective, and not just some high-tech gimmick. For manufacturers, following these rules is the key to getting their devices approved without unnecessary headaches.

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 Cracking the Code: How to Survive the FDA’s AI-Enabled Medical Device Guidance and Maintain Your Sanity

CE Marking: Your Electronic Product’s Passport to Europe

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