Self-Certification vs. Notified Body: Which Path Does Your Product Need?
Jonas Detlefsen
Director at EdgeComply
If you are a North American manufacturer looking at the European market, you are likely staring at your machine right now and feeling a knot of anxiety.
Maybe it’s a harvester with a spinning blade. Maybe it’s a heavy coil carrier that weighs ten tons. Maybe it’s a high-voltage engine test bench. Whatever it is, your "OSHA brain" is screaming one thing:
"This looks dangerous. I definitely need a government-approved auditor to sign off on this."
It’s a natural reaction. In the US and Canada, the "Gold Standard" is a third-party listing (UL, ETL, CSA). You pay a Nationally Recognized Testing Laboratory (NRTL) to test your machine, they slap a sticker on it, and you sleep well at night knowing you have a "shield" against liability.
But applying this US mindset to the EU market is a strategic error.
In Europe, safety compliance is based on process accountability, not just a third-party sticker. Unless your machine falls onto a very specific, short list of "High-Risk" equipment, hiring a Notified Body (the EU equivalent of an NRTL) isn't just unnecessary, it is a liability to your speed, your budget, and your engineering freedom.
Here is why the smartest manufacturers are choosing Self-Certification, and why "doing it yourself" doesn't mean what you think it does.
The "UL" Hangover: Why You Want a Chaperone
We see this constantly. You have a machine that could technically hurt someone if they climbed inside it (which is true of almost all machinery). You assume that because it has moving parts, high voltage, or blades, you are legally required to have an external auditor—a Notified Body—inspect and certify it.
You want the "stamp of approval" because it feels safe.
But in the European Union, under the Machinery Directive (2006/42/EC) and the incoming Machinery Regulation (EU) 2023/1230, the default path for 90% of machinery is Self-Certification (Internal Production Control).
Choosing to pay for a third-party certificate when you don’t need one isn’t "extra safety." It’s a strategic bottleneck. Here are four reasons why you should avoid it if you can.
4 Strategic Reasons to Avoid a Notified Body
1. The Liability Myth (The "Paper Shield")
This is the single biggest misconception we hear on consultation calls. Manufacturers think, "If the Notified Body approves my machine, and then it hurts someone in Germany, the Notified Body shares the blame."
The Reality: Under EU Law, you (the manufacturer) sign the Declaration of Conformity.
Even if you pay a Notified Body €20,000 to review your machine, they do not sign the final document. You do. You retain 100% of the legal liability. If an accident happens, the authorities will come for your Technical File. If that file is weak, the fact that a Notified Body looked at it won't save you.
You are paying tens of thousands of dollars for a shield made of paper. That budget is much better spent on building a defensible, bulletproof Risk Assessment—which is your actual legal defense.
2. The "Frozen Design" Problem
North American manufacturers are agile. You iterate. You move from Version 3 to Version 4. You add features based on customer feedback.
The Notified Body Trap: An EC Type Examination Certificate applies to the specific configuration you submitted.
Want to change the safety PLC logic? Resubmit.
Want to switch from a Sick light curtain to a Keyence scanner? Resubmit.
Want to add a new robotic arm module? Resubmit.
Using a Notified Body "freezes" your design. Every significant change requires a conversation with your auditor, potential new fees, and weeks of waiting.
The Self-Cert Advantage: You maintain Engineering Freedom. If you update the machine, you simply verify the safety change internally, update your Technical File, and keep shipping. You remain in control of your own roadmap.
3. Speed to Market (Don't Let Bureaucracy Kill Your POs)
We recently spoke to a lead who had "pending POs" for a solar cleaning robot but was terrified of the compliance timeline.
The Bottleneck: Notified Bodies in Europe are currently overwhelmed due to massive regulatory shifts (such as the new Machinery Regulation). If you submit a file for review today, you could be looking at a 3 to 9-month wait just to get your certificate.
The Risk: Your product sits in a warehouse collecting dust while your competitors—who chose self-certification—are delivering units.
With Self-Certification, you move at the speed of your own competence. The moment your Technical File is complete and compliant, you sign the Declaration, affix the CE mark, and ship.
4. Smart Allocation of Capital (It's Not About Being "Cheap")
Let’s be clear: We aren't suggesting you cut corners. We are suggesting you allocate capital intelligently.
An EC Type Examination from a Notified Body can cost €25,000 to €50,000+ in fees alone. That does not include the cost of the testing, the travel expenses for the auditor, or the consulting work needed to prepare the files for them.
The Argument: Take that €50k you were going to hand to a German testing lab for a stamp you don't need, and reallocate it.
Spend it on higher-quality safety components (better interlocks, redundant contactors).
Spend it on a third-party audit of your documentation (where the real legal risk lies).
Don’t pay for a "certificate." Pay for actual safety and robustness.
5. The "Turnkey" Myth
Many manufacturers assume that hiring a Notified Body is a "hands-off" solution. They think: "I just ship my machine to the lab, they test it, write the paperwork, give me a sticker, and I'm done."
The Reality: Notified Bodies are auditors, not consultants.
They will test your machine, but they will not write your Operator's Manual.
They will not compile your Technical File structure.
They will not draft your Declaration of Conformity.
Take the case of a recent client who had paid a major testing lab for certification services. They received comprehensive test results but were surprised to learn they still needed to develop all the accompanying documentation themselves. The lab provided the test data, but the client is responsible for creating the Technical File, manual, and Declaration of Conformity.
The "High-Risk" List: The Only Time You Must Call the Auditors
"But isn't my machine high risk?"
This is where the "vibe check" fails. In the US, "high risk" is a subjective feeling based on how dangerous the machine looks. In the EU, "High Risk" is a specific, rigid list.
This list is found in Annex IV of the Machinery Directive (or Annex I of the new Regulation). If your machine is on this list, and you are not strictly following Harmonized Standards, then you must use a Notified Body.
What’s on the list?
It is extremely specific:
Circular saws for working wood/meat.
Vehicle lifts.
Injection molding machines.
Man-lifts (devices for lifting people more than 3 meters).
What is usually NOT on the list (even though it looks scary)?
Industrial Robotic Cells: (Usually self-certifiable).
Harvesters: We spoke to a lead with a harvesting machine that used blades. He was convinced he needed an auditor. But because it wasn't a specific type of woodworking or meat saw, it qualified for Self-Certification.
Heavy Transport Vehicles: Large coil carriers or industrial AGVs are often self-certifiable.
Engine Test Benches: High voltage and moving parts? Yes. Annex IV? No.
The Rule of Thumb: If you aren't cutting wood, meat, or lifting people, you probably don't need a Notified Body.
The Reality of Self-Certification: Not a Free Pass
This is the second most dangerous misconception.
When manufacturers hear "Self-Certification," they often think: "Great! We just write a letter saying it's safe, sign it, and ship it."
Absolutely not.
"Self-Certification" means you take responsibility for the proof. It does not mean you don't need proof. You cannot just "eyeball" compliance. You still need hard data to back up your Technical File.
Regardless of whether a Notified Body is involved or not, you will need all of the following to legally use the CE mark on your product:
Technical File: Think of this as your "Audit Defense Folder." It must contain all your compliance proof (schematics, test reports, risk assessments) so it’s ready for inspection by regulators or customs.
Risk Assessment: This is a critical element of your Technical File, is necessary to understand applicable standards, and must often follow a certain predetermined format (e.g. ISO 12100).
Compliant Labels & User Manuals: Europe has various traceability and language requirements that form part of your CE compliance.
Declaration of Conformity: This is the critical legal document that you sign, declaring compliance with the relevant directives. Usually, this is the first document you'll be asked about.
When You Still Need a Lab
Even if you don't need a Notified Body to approve the machine, you likely lack the equipment to test it against Harmonized Standards. For example, you cannot prove compliance with a standard like EN 60204-1 using a standard multimeter from Home Depot. You need calibrated Hi-Pot testers and ground bond testers to prove the machine won't electrocute an operator.
The Distinction: In the Self-Certification path, you hire a lab to generate test data, which goes into your file as evidence, not to issue a certificate of approval. You own the process; the lab is just a vendor providing data points.
Checklist: Defining Your Strategy
Before you call a Notified Body and sign a check for €40,000, run through this checklist:
Classification: Check Annex IV of the Machinery Directive. Is your specific machine type listed? (If no -> Self-Certify).
Gap Analysis: Look at your North American compliance. Do you have UL/CSA test reports? Often, a "Gap Analysis" can show that your existing electrical testing covers 80% of the EU requirements, saving you from re-testing entirely.
Lab Strategy: Do you actually need to ship your machine to a lab? For large machinery (like the 10-ton coil carrier), we can often arrange for On-Site Testing, where the lab comes to your factory floor, saving thousands in logistics.
Conclusion: You Need a Partner, Not Just an Auditor
Using a Notified Body when not required is like wearing a life jacket to sit in a bathtub. It’s expensive, uncomfortable, restrictive, and everyone knows it’s unnecessary.
But you still need to swim.
The challenge of Self-Certification is that the burden of proof sits entirely on your shoulders. You cannot just "wing it" with a template you found online. If a regulator asks for your Technical File, it needs to be airtight.
This is where EdgeComply fits in.
We are not a Notified Body. We don't just audit you and charge a fee. We act as your Temporary Compliance Department.
We Identify Your Exact CE Gaps: Based on your product data and existing compliance paperwork, our experts compile a rock-solid CE compliance checklist containing all the regulations, standards, and requirements that truly apply to you.
We Build Your Documentation: Our team compiles your Technical File, your Risk Assessment, Declaration of Conformity (DoC), ready for signature.
We Manage the Labs: We know exactly which tests are legally required and which are "nice to have," preventing you from over-spending on unnecessary lab work.
We take you from where you are today to full CE compliance.
Want pragmatic CE support?
Book your free 30-minute CE consultation to discuss whether you can self-certify and how EdgeComply can support you.
