Category: CE Marking

Notified Body

When entering the European market with your product, obtaining CE marking is a crucial step. This marking shows that your product complies with EU safety, health and environmental protection legislation. But whether you need a Notified Body depends on several factors, such as the product category and associated risks. A Notified Body is an organization designated by the European Commission within Europe authorized to perform conformity assessments according to the relevant directives.

Self CE certification

For some products, self-certification is sufficient. This means that as a manufacturer, you can self-declare that your product meets the required standards, after going through the necessary tests and compiling the technical documentation. Products such as simple household appliances and toys can often obtain CE marking without the intervention of a Notified Body, provided the risks are low and the standards are clearly defined. In such cases, you save not only time but also the costs associated with external review.

When do you need a notified body?

However, for products with higher risks, the role of a Notified Body is indispensable. Consider medical devices, explosion-proof equipment, and certain machinery. These products require a more thorough and independent assessment to ensure that they meet strict safety standards. The Notified Body conducts inspections, tests and audits, and issues the necessary certificates. This process provides additional assurance to both the manufacturer and the end user that the product meets all legal requirements.

What notified bodies are there?

Some well-known Notified Bodies are TÜV Rheinland, BSI Group, SGS, Dekra, and UL. These organizations have the expertise and authority to conduct detailed inspections, tests and audits to ensure that products meet strict EU standards.

The 4-digit code assigned to a Notified Body is a unique identifier used to identify the specific organization that performed the conformity assessment. This code is often displayed next to the CE mark on a product, indicating that an approved Notified Body was involved in the assessment and certification. For example, if you see a product with the CE mark and the code “0123,” it means that the Notified Body with the code 0123, in this case TÜV SÜD, approved the product. This system ensures transparency and traceability in the conformity assessment process.

For more information on Notified Bodies and their specific roles, please visit the NANDO website. Here you will find a complete list of recognized Notified Bodies and their respective 4-digit codes, as well as detailed information on their competencies and certification areas.

Conclusion

In short, engaging a Notified Body is not always mandatory, but essential for products with higher risks or complex regulations. It is important to know and understand the specific requirements for your product category. By determining early whether a Notified Body is needed, you can take the right steps to ensure that your product enters the European market safely and legally. Whether you choose self-certification or external assessment, complying with CE regulations is a fundamental part of building trust and success in the European marketplace.

Within Instrux, we have years of experience when it comes to working with Notified Bodies. Looking for someone to handle the contact for you? Or do you want to make sure you need one? If so, please contact us.

What is CE marking?

CE marking stands for “Conformité Européenne” and shows that a product complies with EU legislation. The marking is required for several product categories and is a manufacturer’s declaration that the product meets EU safety standards. It is important to note that the CE mark is not a quality mark, but rather a compliance marker, meaning that the product was evaluated before it was put on the market.

When is CE marking Mandatory?

CE marking is required for several product categories, including toys, electrical equipment, medical devices, machinery, personal protective equipment, construction products and more. Each of these categories has its own specific guidelines and standards that must be met before a product can bear the CE mark. Depending on the category, the process for obtaining CE marking can vary, from self-certification to mandatory independent assessment by designated bodies. A good way to see if CE is mandatory is to use the RFO website. Because of their easy system, that’s how you know if you are required to have CE. This system can be found here.

Briefly, it applies to the following products, among others:

• Machinery
• Medical devices
• Construction Products
• Toys
• Personal protective equipment
• Electrical, electronic and energy related products
• Medical devices
• Measuring and weighing equipment
• Transportation Equipment

The Consequences of Noncompliance

Failure to meet CE marking requirements can lead to significant consequences. This can range from fines and recalls to an outright ban on the sale of the product in the EEA. These consequences can not only cause financial damage, but also severely damage a company’s reputation. CE marking, then, is not something to be taken lightly; it is a crucial aspect of product compliance that requires serious attention.

The importance of compliance

Compliance with CE marking requirements is not only a legal necessity, but also an essential part of ensuring the safety and reliability of products within the EEA. Instrux provides expertise and support in navigating the complex world of product compliance, from interpreting legislation to supporting the certification process. By ensuring your products are compliant, you are investing in the safety of your customers and the integrity of your brand.

Let’s get specific

Instrux is all about products, and that means we look at things in detail, especially when it comes to insurance. One specific component we cannot overlook is product liability.

In our world, where we deal exclusively with products, it is crucial to understand how product liability fits into the bigger picture of business insurance. Therefore, product liability insurance is often part of the many business liability insurance policies that can be purchased.

What exactly is product liability?

Let’s face it: in the world of production and sales, something can always go wrong. Product liability places responsibility on manufacturers and sellers when their products cause damage. Whether it is a faulty coffee maker or a mischievous toy robot, the legal implications are real. The idea is simple: if your product gets someone into trouble, you as the producer or seller are liable. This forces companies to think seriously about the safety and quality of what they put on the market.

What do you need the insurance for?

Imagine: someone uses your product and things go completely wrong, from injury to damage, and suddenly you have a fat claim on your hands. As a company, you are obviously not waiting for this, but according to article 6:185 of the Civil Code in the Netherlands, a manufacturer is liable for damage caused by a defective product. So what now, you have to start paying immer by law.

Fortunately, there is then insurance that can assist. They will take on this claim and ensure that you as a company remain indemnified. Of course, they are not doing this out of the goodness of their hearts, as you have to pay a premium that is usually based on your turnover and industry.

But beware, there are snags

As with any insurance, there are points of interest. These show up in the fine print found in your insurer’s terms and conditions. As a result, you may think you are covered for damages when in reality you are not. So always carefully read terms and conditions of your insurance. Also, it is always advisable to hire an advisor for tricky insurance policies. At Instrux we always recommend Zuiderhuis, they can give expert advice the different insurance policies that may be useful for a business.

Without CE, no insurance

In addition to the fine print that sometimes makes you wonder, there is also a big letter that should be clear: no CE, no insurance. And by this we do not mean that you have to have CE on every product, as this is not allowed. No, we would like to emphasize the need for valid CE documentation. In fact, before they decide to pay out, the insurance company will ask you if they can review your documentation. If they subsequently discover that this documentation was incomplete or invalid at the time of the claim, you will still have to pay for everything out of pocket.

Betrap jij nu jezelf erop dat je al enige tijd premie betaalt, maar niet zeker weet of je wel echt dekking hebt bij schade omdat je CE documenten nooit gecontroleerd zijn? Neem dan vrijblijvend contact met ons op, dan helpt Instrux jou met het zorgen van een dekkende verzekering.

Enter the new year safely

With the approaching New Year’s Eve, many are looking forward to an evening of celebration, drinking and fireworks. Unfortunately, however, we are seeing a worrisome increase in injuries during these festivities. Of the 1253 cases during the turn of the year 2022-2023, as many as 25% resulted in (permanent) eye damage. In this blog post, we take a critical look at the CE marking of fireworks glasses, a seemingly simple accessory that is crucial to protecting our eyes.

Requirements for Fireworks Glasses

Fireworks glasses must meet strict requirements to be considered safe. The EU Type Examination Procedure is essential here. This means that a Notified Body, a notified body, has reviewed the documentation before fireworks glasses with a CE mark can be placed on the market. However, these agencies are located only within the EU, resulting in significant costs.

In addition, fireworks glasses must meet specific standards, including EN 166 and EN 167. Without this approval, these glasses may not be sold as protective against fireworks. Unfortunately, despite these clear guidelines, we see several festival glasses, including those with lights, being sold as “fireworks glasses” without adequate compliance documents. A critical note is in order here, especially with regard to popular platforms such as globe, which sometimes fail to ensure the security of their customers.

So as a consumer, you need to make sure you inquire about the certifications of the glasses. Before you know it, you put a regular piece of plastic on your face, potentially putting you at even greater risk.

List of Safe Products

To give you and your loved ones peace of mind during the New Year, we at Instrux have compiled a list of fireworks glasses that we have determined meet safety requirements. With these, you can go into the New Year with confidence, knowing that your eyes are well protected.

• Outlook fireworks goggles
• Climax Fireworks Goggles
• Uvex Fireworks Goggles

𝐕𝐞𝐫𝐤𝐨𝐨𝐩 𝐣𝐢𝐣 “𝐯𝐮𝐮𝐫𝐰𝐞𝐫𝐤𝐛𝐫𝐢𝐥𝐥𝐞𝐧” 𝐞𝐧 𝐛𝐞𝐧 𝐣𝐞 𝐯𝐚𝐧 𝐦𝐞𝐧𝐢𝐧𝐠 𝐝𝐚𝐭 𝐣𝐞 𝐨𝐨𝐤 𝐨𝐩 𝐝𝐞 𝐯𝐞𝐢𝐥𝐢𝐠𝐞 𝐥𝐢𝐣𝐬𝐭 𝐡𝐨𝐨𝐫𝐭? 𝐒𝐭𝐮𝐮𝐫 𝐨𝐧𝐬 𝐝𝐚𝐧 𝐞𝐞𝐧 𝐦𝐚𝐢𝐥 𝐨𝐩 𝐢𝐧𝐟𝐨@𝐢𝐧𝐬𝐭𝐫𝐮𝐱.𝐧𝐥 𝐞𝐧 𝐧𝐚 𝐛𝐞𝐯𝐞𝐬𝐭𝐢𝐠𝐢𝐧𝐠 𝐯𝐨𝐞𝐠𝐞𝐧 𝐰𝐞 𝐣𝐞 𝐭𝐨𝐞.

Would you like Instrux to support you in certifying your “fireworks goggles,” safety glasses or other Personal Protective Equipment? If so, please contact us.

What is a Technical File?

The technical file: it may sound like a bundle of papers and documents, but it is the most important document when it comes to obtaining CE marking for your products. In this article, we take a closer look at what all must be in a technical file, according to various CE directives and regulations.

What should be in the technical file for consumer electronics/items?

Each guideline may differ on exactly what should be in a file. In general, though, the following points are always required by EU law:

(a) a general description of the electrical equipment;
(b) design and manufacturing drawings as well as diagrams of components, parts, circuits, etc;
(c) adequate risk analysis and assessment.
(d) descriptions and explanations necessary for understanding those drawings and diagrams and the operation of the electrical equipment;
(e) a list of the harmonized standards applied in whole or in part
(f) the results of design calculations, investigations, etc., performed; and
(g) test reports.
(h) declaration of conformity

Compilation of the technical file is a crucial step in the CE marking process, namely step 5. This brings together all the information needed to demonstrate regulatory compliance. Should you need help with step 5, Instrux can provide excellent assistance with that. You can request assistance through our intuitive order page, or through our contact page.

Access to Technical File: Important for Market Supervision

When there are doubts about the safety of a product or compliance with directives, the technical file should be immediately available to market surveillance authorities. If the product is actually found to be unsafe or non-compliant, authorities may even demand that the product be removed from the market through a product recall.

Keeping the technical file is serious business. Generally, the manufacturer or importer must retain it for 10 years. Market regulators within the European Union can demand a copy of the technical dossier even many years after the product is launched. However, clients do not necessarily have to have access to this file; it is not required to be disclosed.

Do I need a declaration of conformity?

A declaration of conformity is required to show that the product complies with European safety standards and legislation, specifically CE legislation. This is important because otherwise the product may not be sold in the European market. It is also a way to build trust with customers because they can be confident that the product is safe and compliant with regulations.

Many products we use in our daily lives require an EC declaration. Consider small electrical devices such as, cell phone chargers, headphones, shavers and other portable electronics. But don’t forget that toys for children and babies are also subject to this. For example: soft toys, puzzles, blocks and other educational toys.

Important points in a declaration of conformity

A declaration of conformity contains essential information about the product, manufacturer and applicable standards. Key components to be included in the statement include:

• The name and address of the manufacturer
• The description of the product
• The European guidelines used
• The standards and/or technical specifications used to assess the product’s compliance with safety standards
• Information on the testing procedures performed to determine whether the product is safe
• Date and signature of authorized person within the organization

What are the dangers of not having this statement?

The dangers of not having a declaration of conformity or having an incorrect declaration of conformity are great. First of all, it is illegal to sell products without having a declaration of conformity. In addition, having an incorrect declaration of conformity can lead to unsafe products and thus risks to users’ health.

Another important factor that can affect not having a declaration of conformity is the risk of liability for the manufacturer or seller. If a product does not comply with applicable regulations and an accident or incident occurs with the product, the manufacturer or seller may be held liable for any damages or injuries. This can lead to financial losses and reputational damage for the company.

Therefore, it is critical for companies marketing products to have a declaration of conformity indicating that the product complies with applicable regulations and is safe for use. This can help reduce liability and increase consumer confidence in the product. Therefore, pay close attention to which party you choose to prepare your declaration of conformity. It seems like a simple document that can do little harm, but in reality, this is a very different case.

Do you now feel that you would like an expert to prepare the compliance statement for you? Then simply apply here for a declaration of conformity prepared by experts at Instrux.

What is a model number?

A model number is a unique code assigned to a product that distinguishes it from other products. Think of it as your product’s ID card: unique, distinctive and informative. This number is often used by manufacturers and distributors to catalog and track their products.

Model numbers are essential for multiple aspects of product management and compliance:

1. Identification and Tracking: Model numbers help quickly identify products, especially in cases where titles or descriptions may overlap.
2. Quality assurance: In case of recalls or quality checks, specific batches can be easily traced.
3. Market confidence: Customers and regulators see model numbers as a sign of professionalism and legitimacy. This increases trust and credibility.
4. Compliance: For products covered by certain standards (such as CE marked items), a model number is part of the mandatory information to meet compliance requirements.

Is a Model Number Required?

For certain product categories, especially those subject to strict safety standards, the use of a model number is not only recommended, but required by law. This is especially true for products that require CE marking. The CE mark, which stands for “Conformité Européenne,” is a declaration that the product complies with EU regulations. Having a unique model number is part of this compliance because it shows that each product is traceable and identifiable.

As an e-commerce business owner, it is important to understand when and why a model number is needed. For products covered by specific regulations, such as electronic equipment, toys, or medical devices, it is not just a matter of best practice, but a legal requirement.

How to Invent Your Own Model Number

Creating an effective model number is an important part of product management and compliance. Here is a simple step-by-step guide to help you come up with your own model numbers.

Step-by-Step Guide

1. Start with a Unique Base: Choose a unique set of letters and/or numbers that represent your company or product line. This forms the basis of your model number.
2. Add Product Specific Details: Consider adding numbers or letters that indicate specific product features, such as size, color, or version.
3. Keep it Simple and Clear: Avoid overly long or complicated codes. A model number should be easy to read and remember.
4. Consistency is Key: Ensure a uniform structure in all your model numbers. This facilitates identification and tracking.

Importance of a Model Number Register

Keeping a record of your model numbers is essential. This not only helps organize your products, but also provides an easy reference in case of compliance checks or customer inquiries.

Tips and Best Practices

• Be Unique: Make sure each model number is unique to each product.
• Plan Ahead: Think about how your model numbering system can grow with your product line.
• Check for Duplicates: Before assigning a model number, check that it is not already in use.

Now that you know how to come up with your own model number, it is important to understand that self-conceived model numbers can sometimes lead to non-valid documentation. In the next section, we will explore this risk and possible solutions.

Proprietary Model Number and Use of External Reports and Certificates

Designing your own model numbers for your products may seem practical, but it presents significant challenges, especially when it comes to linking them to existing reports and certificates.

Non-Compliance Risks.

One of the biggest problems with not being able to link your unique model number to official documentation is the risk of non-compliance. This is because your product is no longer traceable to the matching documentation. This can cause your documentation to be considered noncompliant. After all, an inspector cannot verify that you really have the same product as on the reports. Indeed, counterfeiting in appearance is very common in these times.

A simple document provides the solution

For e-commerce entrepreneurs navigating the complexities of model number management and compliance, Instrux offers an effective and easy-to-use solution with their Declaration of Equivalence template.

The Role of the Declaration of Equivalence.

The Declaration of Equivalence is an important document that, although unofficial, is widely accepted by inspectors and regulatory authorities. It serves as proof that a product meets the relevant standards, even if the model number differs from the original documentation.

Use is really very simple, you only need to receive the data and a signature from the owner of the documentation. Indeed, in this statement, the owner states that even though the model numbers are different, the products are identical to each other. This statement allows you to use the documentation with the other model number.

How did you get this template?

Again, very simple: just send us an email with a request to share this template. In no time we will have these sent to you so that you too can use your own model numbers while complying with legislation.