If my product has CE marking, does it automatically come with a Certificate of Conformity?

Seeing a CE mark and assuming you're compliant? This common oversight can cause serious import delays. Let's clarify what you truly need for smooth market access.

No, a CE marking does not automatically come with a Certificate of Conformity (CofC). The CofC, or Declaration of Conformity, is a separate legal document. The manufacturer must create it to formally declare that the product meets all EU requirements.

For 18 years, we've helped clients navigate global trade regulations. A frequent point of confusion is the relationship between the CE mark¹ and its supporting paperwork. It's easy to think the mark on the product is the final step, but it's really just the tip of the iceberg. The real proof is in the documentation. Without the right papers, a product with a CE mark can still be stopped at the border, disrupting your entire supply chain². Let’s break down exactly what you need to ask for and why it’s so important.

Who is responsible for issuing the Certificate of Conformity: the manufacturer or the seller?

Are you unsure who to ask for the Declaration of Conformity? Chasing the wrong party wastes valuable time and can easily delay your projects. Let's clear up the chain of responsibility.

The manufacturer or their authorized EU-based representative is solely responsible for creating and signing the Declaration of Conformity. Sellers, such as importers or distributors, must verify that the certificate exists, but they do not issue it themselves.

At Weigherps, this is a core part of our production process. We see it as our fundamental duty. The responsibility is clearly defined in EU legislation to ensure accountability. It's not a task that can be passed down the line. Here’s a deeper look at the specific roles.

The Manufacturer's Duty

The manufacturer is at the heart of the compliance process. Before we even affix a CE mark to one of our industrial scales, we have to complete several crucial steps. First, we conduct a conformity assessment³. This involves testing the product against all relevant EU directives, such as the Low Voltage Directive or the Machinery Directive. Second, we compile a detailed Technical File. This file contains all the evidence, like design blueprints, risk assessments, and test reports. Only after all this is done do we, the manufacturer, draw up and sign the Declaration of Conformity. It's our legal statement, on which our name and reputation rest.

The Seller's Obligation

A seller, whether an importer bringing goods into the EU or a distributor selling them, has a different but equally important role. They are the gatekeepers. They don't create the CofC, but they must perform due diligence. This means they are obligated to check that the manufacturer has correctly applied the CE marking and issued a valid Declaration of Conformity. They should have a copy of the CofC and be able to provide it to national authorities upon request. If they can't, they could be held liable. As a buyer, you should expect your supplier to facilitate this and provide the manufacturer's document.

Certificate of Conformity vs. Calibration: What's the Real Difference?

Confusing legal compliance with operational accuracy? This common mix-up can lead to you accepting a product that is legal but inaccurate, or worse, facing unexpected legal issues.

A Certificate of Conformity (CofC) proves a product meets legal safety and health standards for market entry. In contrast, a Calibration Certificate verifies that a measuring instrument, like a scale, provides accurate readings against a known standard.

Think of it this way: one document gets you in the door, and the other ensures you do your job correctly once you're inside. At our facility, every scale undergoes both processes, but for very different reasons. The CofC is about legal permission to sell, while calibration is about performance and reliability. Let's break down the key differences to make it crystal clear.

Different Goals and Scopes

The primary goal of a Declaration of Conformity is to declare that a product is safe and complies with all relevant EU laws. It covers aspects like electrical safety, electromagnetic compatibility⁴, and environmental protection. It applies to a huge range of products. A Calibration Certificate⁵, however, has a much narrower and more specific goal: to prove measurement accuracy. It is only relevant for testing and measurement equipment, like our industrial scales. It tells you how far off the instrument's reading is from the true value.

A Tale of Two Authorities

The bodies responsible for these documents are completely different.

• Declaration of Conformity: Issued and signed only by the manufacturer or their authorized representative. It is a self-declaration.
• Calibration Certificate: Issued by an accredited calibration laboratory. This can be the manufacturer's internal lab (if accredited) or, more commonly, a third-party lab. This process involves comparing the device to traceable standards.

Validity Period

Their lifespans are also distinct. A CofC is generally valid for the life of the product model, as long as the product and relevant standards don't change. A Calibration Certificate has a limited validity, typically one year. Your scale's accuracy can drift over time due to use, environmental changes, or wear and tear, so periodic re-calibration is essential for quality assurance.

What are the 5 key documents for your industrial scale?

Are you feeling overwhelmed by the paperwork for your new equipment? Missing just one critical document can halt your production line or cause you to fail an important audit.

For any industrial scale, you need five key documents: the Declaration of Conformity, a Calibration Certificate, a full Test Report, the product's Technical File, and a general Statement of Conformity. These ensure both legal compliance and operational quality.

As a manufacturer, we prepare these documents as part of our comprehensive quality assurance process. We know that for our clients, especially those in software and tech integration, having the right documentation is non-negotiable. It’s the foundation of a reliable and verifiable system. Here is the complete checklist you should have when purchasing any industrial scale.

1. Declaration of Conformity (CofC)

This is your golden ticket for market access in the EU. As discussed, it’s the manufacturer's legal declaration that the scale meets all relevant health and safety laws. Always ask for this document by name and ensure it is signed and dated.

2. Calibration Certificate

This document is your proof of accuracy. It shows that the scale was tested against certified, traceable weights and lists its performance. For any process where weight is a critical parameter, this certificate is essential for your internal Quality Management System (like ISO 9001⁶).

3. Test Report

The test report provides the raw data and results from the various tests performed on the scale. This could include weight tests, battery life tests, and software validation. It's the detailed evidence that supports the claims made in the other certificates. It's particularly useful for technical directors who need to verify performance specifics.

4. Technical File

While you may not receive the entire technical file, you should know it exists and that your supplier can access information from it. This massive file, held by the manufacturer, contains everything about the scale’s design, development, and testing. Its existence is a sign of a diligent and professional manufacturer.

5. Statement of Conformity (or Certificate of Conformance)

This is a more general document, often confused with the CofC. A Statement of Conformity is a broader declaration from a supplier that a product meets a required specification, which could be a customer's specific purchase order or a particular industry standard. It's a statement of quality assurance between buyer and seller.

How do you use quality documentation like CofC, CofA, and Calibration Certificates?

You've collected all the documents, but what's next? Simply filing them away in a drawer won't protect you during a vendor audit or a regulatory inspection.

Use the Declaration of Conformity (CofC) to prove legal compliance for market entry. Use a Calibration Certificate for internal quality control. And use a Certificate of Analysis (CofA) to verify a product's specific material composition and test results.

These documents are not just bureaucratic hurdles; they are active tools for your business. As a software provider integrating with hardware, this paperwork is your link between the physical world of measurement and the digital world of data. It ensures the data your software processes is from a reliable and compliant source. Here’s how to put them to work.

Using Documents for Audits

When a regulator or a major client's quality team comes knocking, these documents are your first line of defense. The Declaration of Conformity proves your equipment is legal. The Calibration Certificate proves your processes are accurate. For ISO 9001 audits, these documents are mandatory evidence that you are controlling your measurement resources. We always advise our clients to keep these documents stored digitally and linked to the specific asset's ID in their system for instant retrieval. This shows an auditor you have a mature and organized quality system.

Using Documents for System Integration

For you as a software vendor, this documentation is critical. When you integrate our scale with your system, the Calibration Certificate provides the baseline for the data's integrity. You can build software features that alert users when a scale is due for re-calibration, adding value to your service. The CofC, in turn, assures your end-users that the entire integrated system, hardware and software, is built on a foundation of legal compliance. This is a powerful selling point.

What about a Certificate of Analysis (CofA)?

While less common for a finished product like a scale, a CofA is crucial in component manufacturing. It certifies that a specific batch of raw material (like a grade of steel or a chemical) meets the required purity and property specifications. If your scale is used in a GxP-regulated environment (pharma or food), you might require a CofA for materials that come in contact with the product, like a stainless steel platform. It provides traceability right down to the material level.

Conclusion

A CE mark is just the start. Always get a separate Certificate of Conformity from your manufacturer. And for quality assurance, maintain a regular calibration schedule to ensure accuracy and compliance.