#eu ce marking

[mariacarey544]

Guide to the CE Marking Process 

Introduction  

The CE mark is an obligatory symbol found on numerous products across Europe, indicating conformity with essential safety, health, and environmental standards set by the European Union (EU). It is a prerequisite for manufacturers to apply the EU CE marking to their products for them to be sold in Europe. Understanding the CE marking process is vital for efficiently navigating product placement within the European Economic Area (EEA). 

What is CE?  

CE stands for "Conformité Européenne," the French term for European conformance. It is mandatory for products sold in all 27 EU member states, as well as Iceland, Norway, and Liechtenstein. While many products in Turkey must bear the EU CE Marking, Switzerland only accepts it for specific products. 

CE Marking Requirements in the EU  

CE marking is compulsory for products meeting EU criteria and mandated by regulatory authorities. Some products must comply with multiple EU regulations simultaneously. Before affixing the CE mark to a product, ensuring compliance with all applicable regulations is essential. 

 Fig: Objective of EU in mandating CE marking 

 Steps to Obtain CE Marking  

Here's a detailed breakdown of the key steps involved in the CE marking process: 

Identifying Applicable Directives: Determine which EU directives apply to your specific product, outlining essential safety, health, and environmental requirements. Utilize resources like the EU's "NANDO" database to identify relevant directives. 

Understanding Essential Requirements: Delve into the specific essential requirements outlined for your product category, forming the benchmark for compliance. 

Selecting the Conformity Assessment Route: Explore various 'modules' available under each directive to determine the appropriate conformity assessment route for your product. 

Assessing Product Conformity: Evaluate your product against essential requirements through internal assessments, external testing, or a combination, depending on the chosen conformity assessment module. 

Creating Technical Documentation: Compile a comprehensive technical file documenting processes, design choices, and test results, serving as evidence of conformity assessment. 

Drafting and Signing the Declaration of Conformity: Issue a formal Declaration of Conformity (DoC) affirming compliance with relevant directives and essential requirements, including crucial information about your organization and the product. 

Affixing the CE Marking: Once all steps are completed and conformity is declared with the applicable directives, affix the CE marking symbol to the product and packaging, indicating readiness for the European market. 

Cost Considerations  

Manufacturers conducting their own conformity assessment won't incur fees. However, if independent assessment by a notified body is required, fees will apply, varying depending on the certification procedure and product complexity. 

Additional Considerations  

Maintain clear records and seek guidance from relevant authorities or professionals, especially for complex products or first-time navigation of the process. Remember, CE marking is an ongoing responsibility, requiring continued compliance with relevant directives even after placing the product on the market. 

Conclusion  

The EU CE marking demonstrates compliance with essential EU Medical Device Consulting standards, facilitating product placement in the European Economic Area (EEA). Following these steps provides a comprehensive understanding of the CE marking process, enabling confidence in bringing products to the European market. 

[cert3global]

Regulatory and Market Intelligence

Regulatory and Market Intelligence refers to the process of gathering, analyzing, and utilizing information related to government regulations and market trends. It involves monitoring changes in laws, policies, and industry dynamics to help businesses make informed decisions, stay compliant with regulations, and seize opportunities in the marketplace.

[certivo]

Mastering RoHS Compliance: Essential Certification Requirements & Best Practices | Certivo

Ensure your products meet RoHS Compliance with our comprehensive guide. Dive into the RoHS Directive and understand the critical RoHS Requirements for restricting hazardous substances in electronic equipment. Learn the process for achieving RoHS Certification, from identifying banned materials to conducting testing methods like XRF and GC-MS. We also cover implementation best practices, including documentation, periodic reviews, and supply-chain transparency, to help you maintain ongoing conformity. Whether you’re updating existing products or launching new ones, this guide equips you with actionable insights for effective Hazardous Substances Compliance.

[freyrsolutions]

Ensure legal and safety compliance in the EU for cosmetics; consumer goods. Learn about PIF, CE marking, labeling, RP, & CPNP portal in this step-by-step guide.

[nexortesttechnologies]

EU MDR: Comprehensive Breakdown of Its Rules & How It Effects The Manufacturers

The European Union Medical Device Regulation (EU MDR) (2017/745) sets out an extensive framework that regulates the manufacture and sale of medical devices in the EU. Enacted in 2017, the EU MDR superseded the erstwhile Medical Devices Directive (MDD) (93/42/EEC) and the Active Implantable Medical Devices Directive (AIMDD) (90/385/EEC). The main goal of the EU MDR is to increase patient safety by enforcing rigorous standards upon the manufacturers of medical devices.

Key Changes Introduced by EU MDR

The MDR came into force on 26th May 2017 and became applicable on 26th May 2021 in all EU member states. The EU MDR brought some major changes to the regulatory framework:

Increased Scope: The regulation now covers a wider scope of products, including those that do not have a medical intent but share similar features with medical devices, like cosmetic implants and contact lenses.

Redesignation of Devices:A large number of devices have been redesignated into higher-risk classes, which require more stringent assessment processes.

Unique Device Identification (UDI): Each device is to be assigned a UDI by manufacturers, which facilitates better traceability in the supply chain.

Clinical Evaluation: Greater emphasis on clinical data, under which manufacturers have to supply solid clinical evidence for the safety and performance of the devices.

Post-Market Surveillance: Manufacturers need to establish good post-market surveillance systems to keep track of the performance of devices and report any adverse events.

CE Marking Under MDR

Acquiring the CE marking is a matter of law for placing medical devices on the EU market. The process of obtaining CE marking has become more rigorous under the EU MDR. Manufacturers are required to verify that their products conform to the General Safety and Performance Requirements (GSPR) of the regulation.

This entails a careful conformity assessment, possibly involving the services of a Notified Body, particularly for higher-risk devices. CE marking shall be attached visibly, legibly, and permanently to the device or on its packaging before it is made available for sale on the market.

Effects on Manufacturers

The adoption of the EU MDR has fundamental effects on the manufacturers of medical devices: Added Compliance Costs: Compliance with the new legislation entails heavy investment in quality management systems, clinical trials, and personnel training. Additional requirements translate to higher operating expenses.

Regulatory Uncertainty: The switch from the MDD to the EU MDR has created uncertainties, mainly related to how to interpret some of the provisions and the availability of Notified Bodies. Such uncertainty may lead to increased time to introduce products onto the market.

Market Entry Barriers: Small and medium-sized companies, and also manufacturers, will find it hard to comply with the strict standards, and they might be restrained from competing within the EU market.

Supply Chain Changes: UDIs and enhanced traceability compel manufacturers to shift their supply chain activities in such a way that all economic players are compliant with the regulation.

Compliance Measures

Manufacturers can navigate the challenges of the EU MDR by following the below steps:

Device Classification: Categorize the medical device based on its intended use and inherent hazards.

Quality Management System (QMS): Develop a QMS based on ISO 13485 guidelines to control processes efficiently.

Clinical Evaluation: Perform rigorous clinical evaluations to collect evidence of safety and performance of the device.

Technical Documentation: Prepare technical documentation with details of design, manufacturing procedures, and compliance with GSPR.

Work with Notified Bodies: Engage with notified Notified Bodies for conformity assessments, particularly for high-risk devices.

Post-Market Surveillance: Establish systems to follow up on the performance of devices after market placement and create reporting procedures for adverse events.

Role of Nexortest Technologies

Nexortest Technologies is one of the biggest solution partners to companies involved in maintaining compliance with the EU MDR. Possessing extensive experience in the field of regulatory consulting and compliance services Nexortest Technologies provides a list of services specialized in addressing the specific needs of the EU MDR.

Regulatory Consulting: EU MDR offers professional consultancy for the interpretation and enforcement of the requirements and facilitates better understanding and enablement of the manufacturers to meet them.

Quality Management Systems: Installing and implementing strong QMS according to ISO 13485 standards and maintaining consistent quality and compliance.

Clinical Evaluation Support: Providing consultancy services in the establishment and administration of clinical evaluation, helping in the procurement of required clinical evidence.

Technical Documentation Preparation: Facilitating preparation of in-depth technical documentation, a primary requirement for CE marking under MDR.

Training and Education: To train manufacturers through the use of workshops and training modules so that they are well aware of the new regulatory developments and best practices.

Factory Inspection (Where Necessary)

BIS officers, in the case of specific groups, carry out an inspection at the production premises to check against necessary standards.

Review and Issue of Certificate

BIS evaluates the application form, test reports, and findings of inspection.

If the terms are satisfactory, the BIS certificate is given.

Through the use of services offered by Nexortest Technologies, companies will better be able to handle the intricacy of the EU MDR so that their medical devices will be optimally suited to pass the rigorous CE marking in compliance with MDR.

Conclusion

EU MDR is a paradigm shift in the regulatory regime of medical devices in the European Union. Even though its central purpose is patient safety and performance improvement of the device, it also presents great challenges to industry manufacturers.

Compliance is achieved through a thorough knowledge of the regulations, a lot of resources, and, in most instances, partnerships with experienced companies such as Nexortest Technologies. Foreseeing and careful preparation are the key to manufacturers surviving this complicated regulation environment and sustaining access to the EU market.

[mercoglianotrueblog]

Trump bilateralism and Putin multipolarism

#Putin:#EU leaders stand at master feet (Trump),gently wag tails

if #Kyev rest of #Kursk garrison don't cede by #tomorrow morning 6 a.m. they'll be destroyed

EU #CEMark,#Reach, #RoHS,#VAT barriers to entry:#Trump is right

US #default when can't sell debt

https://salvatoremercogliano.blogspot.com/2025/03/trump

[huaktesting]

Understanding EU Directives And CE Mark Compliance For Electronics

Shenzhen HUAK provides comprehensive certification services Ensure compliance and quality with our expert solutions for various industries

[toopeanutcrown]

CE Marking Authority

At CE Marking Authority, we our compliance specialist who set the bar high. We combine our entrepreneurial spirit with original thinking and practical know-how to provide outstanding services and solutions for our customers regulatory needs.

[joyousjoyfuljoyness]

Just learned about the new GPSR Compliance rules coming into effect in a week...

It's requiring anything sold and shipped to the EU to have the following:

Product Compliance

Ensure your products meet applicable EU safety standards (e.g., EN71 for toys or REACH for textiles).

They must also be safe under normal and foreseeable use, including proper testing and risk assessments.

Labeling Compliance

The following information must be included on the product or its packaging:

Your company name, address, and contact information.

Your EU Responsible Person's (EU RP) name, address, and contact information.

A product identifier (e.g., serial, model, or batch number).

Any applicable symbols, such as the CE Mark for toys.Safety warnings or instructions must be in the official language(s) of the EU country where the product is sold. For example, in France, all labelling must be in French. I've included more information regarding safety warnings/instructions and exemptions.

Self-Explanatory Products: Translations/Warnings Required?

Under the GPSR, self-explanatory products like books or candle holders may not require additional instructions or translations.

The key is whether the product's use and safety considerations are transparent to the average consumer without further explanation.

If so, the GPSR does not mandate additional instructions or translations.

Assessing each product individually to ensure compliance is essential. When in doubt, providing clear instructions in the appropriate language(s) is always a safe approach.

Appoint an EU Responsible Person (EU RP)

The EU RP acts as your legal representative in the EU. They are responsible for:

Holding compliance documentation (e.g., testing reports, technical files, declarations of conformity).

Ensuring labelling and documentation meet EU requirements.

Acting as the first point of contact for EU authorities if any compliance issues arise.

Yeah..... I can't comply with this, especially the appointing an EU Responsible Person. Really burdensome on most small businesses!

So I unfortunately had to turn off all shipment to the EU. Sigh.

[cindylouwho-2]

The European Union's General Product Safety Regulations (GPSR): A Huge Mess For Some Small & Micro Businesses

Above is an email Amazon sent to sellers many months ago that covers the basics. Not all marketplaces were as forthcoming - or early - with info.

UPDATED: February 25, 2025

As many of you know, new laws coming into effect Friday December 13, 2024 affect businesses' ability to sell products into the European Union and Northern Ireland (EU and NI). The General Product Safety Regulations (GPSR) impose various requirements on most goods being sold to the EU and NI, and some of those new rules will be very onerous for some small businesses. Furthermore, there are still some unanswered questions that the relevant government bodies hadn't covered until the European Commission did release some more details and an FAQ page very recently [pdf for download at the end of the first section on that page], and until public Q & A sessions were held.

This post contains a brief summary of the GPSR and of the key questions for common small business types, with the best answers I can find at this time. There is a section discussing problems on Etsy (which hasn't yet adapted their platform to the new regulations). I also compiled a list of helpful links including government and marketplace information pages, and places to obtain an "EU Responsible Person" to represent your business.

If anything gets clarified in the near future, this post will be updated.

What Does GPSR Require?

The Amazon summary in the screenshot at the top of this post is one of the easiest to understand, but a shorter overview may work better for some, so here is what eBay has to say:

To comply with the GPSR and related regulations, all business sellers listing items for sale in the EU and NI must include the following information: 1. The product manufacturer's name and contact information 2. If the manufacturer isn’t located in the EU or NI, you’ll have to indicate an EU-based Responsible Person or entity, along with their name and contact details 3. Any relevant product information like model number, pictures, and type 4. Product safety and compliance information like warnings and safety information (which can be included in labels and product manuals) in the local language 5. The CE marking when required by the related regulations applicable to your product

And yes, all of this applies to merchants of all stripes, including small and microbusinesses. Per the EU, “...the GPSR obligations apply to businesses of all sizes. Consumers are entitled to only safe products and therefore exceptions cannot be made based on the size of a business.”

Clearly there are significant hurdles for small and micro businesses: the cost of hiring a responsible person, and the cost of producing the required safety and use instructions and of translating them into local languages. Some may choose to stop sales to the EU and NI instead of complying.

Are There Any Exceptions?

Yes, several types of products are excluded, but most of those already subject to equally strict or even stricter regulations, e.g., medicine, foods, animals etc.

The two main known exceptions of interest to most of my readership are:

Antiques, which seem to be limited to items that are old (but no age is given, as far as I can tell) and generally to art or other collectible items.

Items already available for sale before December 13 of this year.

That second point is good news for many businesses, but please note it only seems to apply to stock made before December 13, not just listings made before that date. Once you run out and need to order or make more products, they then become subject to the GPSR.

Does The GPSR Apply To Digital Products?

It now appears that the new regulations cover items such as digital downloads. The FAQ pdf put out by the European Union very recently states "[t]he GPSR applies to all types of products (physical or digital products too, including software) that are placed or made available on the EU Single Market". At least some analysts agree this can include pretty much everything digital:

I can understand why some folks think that a knitting pattern or a simple art downloadable file should not be covered, and in the future once there is more discussion of and action taken under the GPSR, those products might be excluded. But note that the pdf of FAQs also states "[t]he GPSR is about avoiding and preventing “risks to both physical health and mental health”. Including image files and similar downloads therefore makes some sense.

How Do I Find A "Responsible Person" To Represent My Digital Download Business In The EU?

That's a good question, because I haven't found any verified sources saying they will cover digital items, or any digital sellers mentioning they have found coverage. Many have been denied by the companies they have contacted. [UPDATE: A company called EAS has agreed to represent at least one digital seller.]

If you are aware of any other firms or individuals offering "Responsible Person" services for digital products, please let me know!

(Remember, If you are in the EU/NI, you are the Responsible Person. If your products are manufactured in the EU/NI, the manufacturer is the Responsible Person.)

Does the GPSR Apply To Free Products?

Yes. From the FAQ pdf: "an item provided free of charge falls within the scope of the GPSR.”

In addition to complimentary physical items ("free gifts") sent out with orders, this would seem to include free downloads provided on blogs and social media, on a Patreon site, in YouTube descriptions etc. I’ve not seen much discussion on this aspect of the law for some reason.

Items Offered For Sale Before December 13 Are Exempt, But How Would The Government Know When I First Offered The Product Or When It Was Made?

If you had 100 widgets in stock before December 13 and had them listed on a marketplace or website, by law you can continue to sell those widgets to the EU and NI until all 100 are gone. And if you created a digital file and offered it online before December 13, it should be exempt forever, as long as you do not edit the file after December 13.

But proving you had 100 widgets already made, or that you listed a specific product before the law took effect could be difficult, especially for anyone handmaking their own items. If you are going to continue to sell to the EU and NI after December 13, keep careful records of which stock needs labelling, safety information and translations of use instructions.

Online marketplaces could also create problems if they don't display the date an item was first offered for sale, as happens on Etsy, for example. Every time an item renews, the visible date is reset, and it can be difficult to go through spreadsheets looking for the original listing date, and csv files may not be adequate proof under this law (since they can easily be changed after downloading).

Unfortunately, we won't truly know what evidence will be accepted in these circumstances until the authorities start enforcing these regulations, but this will only be a concern for anyone continuing to sell "old stock" into the EU and NI after December 13, so it is far from the largest concern.

The Case of Etsy - Failure To Comply With The GPSR

Unlike some other marketplaces, Etsy was fairly late in warning its sellers that the GPSR affected them, and how Etsy will approach the law. The blog post included the line "[s]hould Etsy receive a notification from an authority that your product is non-compliant, we will take appropriate action, which may include removing your listing and/or suspending your account." So, the stakes are high here - you could lose your Etsy shop if accused of not complying with the GPSR.

There are currently 2 problems for sellers who decide they can't/won't comply with the GPSR and therefore do not want to offer their items to the EU and NI any more:

Shipping to the UK on Etsy includes Northern Ireland, and sellers anywhere within the UK cannot remove the UK from their shipping profiles. That means they are forced to offer their goods to NI even if they don't want to.

Digital products on Etsy are sold to the whole world by default; there is no way to exclude any countries that Etsy allows sales to. That means every digital listing on Etsy is currently offered in the GPSR jurisdictions, regardless of the seller's wishes or compliance.

The GPSR was published on May 10, 2023. That gave everyone 19 months to get their ducks in a row. However, Etsy has so far done nothing to allow UK and digital sellers to remove their listings from being available in the EU and NI. Nothing.

Support has told some sellers that the corporation is working on it, and that UK sellers could just cancel any sales to NI:

However, it is not good enough to refuse to complete orders to the EU and NI. Any item offered for sale in the EU and NI is automatically subject to the GPSR; just allowing someone to check out is a violation, if the listing and product does not meet the law's requirements.

As of December 13, there is still no way to stop selling to Northern Ireland on Etsy if you are a seller in the United Kingdom, and there is no way for a digital product to be excluded from offer in either the EU or NI. Sadly, this means the only way shops can follow the law is to close for the time being, and some are planning on doing that.

Etsy has failed its sellers, and there is no excuse.

UPDATE (February 25, 2025): Etsy has finally Etsy has updated settings for excluding GPSR countries from those you sell to. Change it here under "Choose how you sell to GPSR states".

More changes to come here under the February updates, including fields for safety information and your responsible person.

And probably the biggest news: Etsy is working on vetting companies that will act as a "responsible person" for its sellers - you know, like eBay already did months ago. Still no word on why Etsy was caught unprepared by legislation that was released almost 2 years ago.

UPDATE (April 15, 2025): Etsy has added fields for safety compliance and an EU responsible person, and now warns shops that "If a product is subject to the GPSR but does not meet the requirements, it may be classified as a “dangerous product” by EEA or NI authorities. This may result in enforcement actions, including fines, product bans, or the removal of your products from the marketplace.

Should Etsy receive notification from an authority that your product is non-compliant, we’ll take appropriate action, which may include removing your listing and/or suspending your account."

Resources and Responsible Person Offerings

I've compiled a separate post on my Patreon, listing some of the official legal and government resources on GPSR, as well as rules and Help pages from some major marketplaces and Print on Demand companies, and a short list of places you can hire a "Responsible Person" for your products:

https://www.patreon.com/posts/sources-and-for-117871846

Please let me know if you find any broken links there, or have other resources to add!

This post will be updated as required.

UPDATED: April 15, 2025

[mariacarey544]

Exploring the CE Marking Procedure

The CE mark serves as a vital indicator of compliance for numerous products marketed within the European Economic Area (EEA). It represents adherence to essential safety, health, environmental, and consumer protection standards established by the European Union (EU). Securing the EU CE marking underscores a manufacturer’s dedication to product safety and facilitates seamless market access throughout the EEA. However, navigating the CE Marking Process can be intricate. This article elucidates the steps involved in achieving CE marking compliance.

Understanding CE

CE, derived from the French term Conformité Européenne, translates to “European Conformity.” It denotes that a product meets diverse safety, health, and environmental protection criteria stipulated by the EU. Simply encountering the EU CE marking on a product signifies its assessment and approval for sale and utilization within the European Economic Area (EEA), encompassing EU member states, Iceland, Liechtenstein, and Norway.

Breaking Down the Significance of CE Marking

Safety: The CE marking signifies that products have undergone rigorous assessment and comply with stringent safety regulations mandated by the EU. This ensures they pose minimal risk of injury or harm to consumers.

Health: Additionally, products bearing the CE marking are free from health hazards, adhering to regulations concerning harmful substances, noise levels, and other potential health risks.

Environmental Protection: The CE marking indicates adherence to environmental protection standards established by the EU, encompassing factors such as resource efficiency, waste generation, and potential environmental impact.

Objectives of CE Marking Implementation by the EU

Ensure Consumer Protection: By enabling consumers to identify products meeting essential safety, health, and environmental standards, the CE marking enhances consumer protection.

Facilitate Fair Competition: The CE marking mandates all businesses, irrespective of their origin, to adhere to uniform regulations when marketing products within the EEA, ensuring fair competition.

Simplify the Free Movement of Goods: By establishing a unified set of standards, the CE marking facilitates the seamless movement of products within the EEA, eliminating additional technical barriers encountered in individual member states.

Procedure for Obtaining CE Marking

Navigating the process of obtaining CE marking for your product involves several key steps:

Identifying the Applicable Directive: Begin by identifying the relevant EU Directive(s) that pertain to your product. Each Directive specifies essential requirements for different product categories, such as machinery or Medical Devices Registration EU. Utilize resources like the NANDO database and official EU websites to determine the applicable Directive.

Understanding Essential Requirements: Once you’ve identified the relevant Directive, carefully review the specific requirements outlined within it. These requirements address aspects of product safety, health, and environmental protection. Assess your product against these requirements to ensure compliance.

Determining Conformity Assessment Route: The CE marking process typically involves self-declaration of conformity by the manufacturer. However, depending on the product category and associated risks, involvement of a Notified Body may be mandatory. Consult the Directive to determine the applicable conformity assessment modules and whether independent assessment is required.

Assessing Product Conformity: Conduct thorough assessments to ensure your product meets the essential requirements outlined in the Directive. This may involve various measures, including internal production controls, risk assessments, testing by notified bodies or accredited laboratories, and technical inspections. Document these assessments meticulously for future reference.

Preparing Technical Documentation: Compile comprehensive technical documentation that serves as evidence of your product’s compliance with the essential requirements. This documentation typically includes product descriptions, design and manufacturing specifications, risk assessments, test reports, and technical drawings.

Drafting and Signing the Declaration of Conformity: Create a formal EU Declaration of Conformity (DoC) wherein you declare your product’s compliance with relevant legislation and assume responsibility for its safety. The DoC must be signed by an authorized representative of your company and readily available to authorities.

Affixing the CE Marking: Once you’ve completed the previous steps and are confident in your product’s compliance, affix the CE marking to your product. Ensure the marking is visible, legible, and indelible, signifying your commitment to ongoing product safety throughout its lifecycle.

Is There Any Fee?

Conducting the conformity assessment yourself does not incur any fees. However, if independent assessment by a notified body is required, fees may apply depending on the certification procedure and product complexity.

Additional Considerations

Seeking guidance from notified bodies or specialized consultants can be advantageous, particularly for complex products or if you’re unfamiliar with the CE marking process. Stay updated on regulatory changes, as Directives and standards are periodically revised.

Conclusion

Understanding the CE marking process empowers manufacturers to ensure their products meet necessary safety and regulatory standards for successful market access within the EEA. While this article provides a general overview, always refer to specific Directives and consult relevant resources for comprehensive and up-to-date information.

[cert3global]

Regulatory and Market Intelligence

Regulatory and market intelligence involves gathering, analyzing, and utilizing information related to government regulations and market trends. Monitoring laws, policies, and industry dynamics can help businesses make informed decisions, stay compliant with regulations, and take advantage of market opportunities. Call us at +44 2080790706

[certivo]

Making CE Product Compliance Easy: How Manufacturers Can Streamline EU Certification with Alex Volf

In this episode of Supply Chain Certified by Certivo, host Kunal Chopra talks with Alex Volf—founder of CE EASY and a leading expert in CE product compliance. With over 20 years at Bosch, Parker, and Hendrickson, Alex reveals how manufacturers can simplify CE marking, avoid compliance delays, and speed up time-to-market. Discover the role of AI in transforming certification processes and fixing supplier bottlenecks.

[freyrsolutions]

Ensure legal and safety compliance in the EU for cosmetics; consumer goods. Learn about PIF, CE marking, labeling, RP, & CPNP portal in this step-by-step guide.

[nexortesttechnologies]

CE Marking: Guide for Manufacturers Seeking EU Market Access

CE marking, short for "Conformité Européenne" (French for "European Conformity"), is a mandatory symbol that indicates a product complies with the European Union's health, safety, and environmental protection standards. This marking is essential for products sold within the European Economic Area (EEA). By affixing the CE mark, manufacturers declare that their products meet all applicable EU directives and regulations, allowing for the free movement of goods across EEA countries. It's important to note that the CE mark is not a quality indicator or certification mark; rather, it signifies legal compliance with EU legislation.

The CE marking process involves several key steps to ensure that a product complies with European Union (EU) regulations and can be legally sold within the European Economic Area (EEA). Here's a step-by-step breakdown:

1. Identify Applicable Directives and Regulations:

Determine which EU directives or regulations apply to your product. Each directive outlines specific requirements related to safety, health, and environmental protection. For example, medical devices are governed by the Medical Devices Directive (MDR 2017/745).

2. Assess Specific Requirements:

Understand the essential requirements stated in the applicable directives. This may involve conducting a risk analysis and ensuring your product meets performance and safety standards.

3. Determine the Conformity Assessment Procedure:

Decide whether your product requires assessment by a Notified Body—a third-party organization authorized by the EU to evaluate product conformity. Not all products need this; some can be self-assessed by the manufacturer.

4. Conduct Product Testing:

Perform necessary tests to verify that your product meets EU requirements. Depending on the product and applicable standards, this testing can be done by an ISO 17025 accredited laboratory.

5. Compile Technical Documentation:

Gather comprehensive documentation detailing your product's design, manufacturing process, and compliance with relevant standards. This technical file should include:

Product description

Design and manufacturing drawings

Risk assessments

Test reports

User manuals

Declarations of conformity

6. Draft and Sign the EU Declaration of Conformity:

Prepare a document in which you, as the manufacturer or authorized representative, declare that the product complies with all relevant EU directives. This declaration must include:

Manufacturer's name and address

Product details (e.g., model, type)

List of applicable EU directives

Standards used to verify compliance

Date and place of issuance

Name and signature of the responsible person

7. Affix the CE Marking:

Once all the above steps are satisfactorily completed, affix the CE marking to your product. Ensure the marking is:

Visible, legible, and indelible

At least 5 mm in height (unless specified otherwise)

Proportional if resized If a Notified Body was involved, include their identification number alongside the CE mark.

By following these steps diligently, manufacturers can ensure their products meet EU standards and are eligible for sale within the EEA.

Why Choose NexorTest Technologies for CE Marking Certification?

We simplify the CE marking process with step-by-step guidance.

Our experts identify the right EU directives and standards for your product.

Save costs with our in-house accredited testing lab.

Tailored solutions ensure your product meets all CE requirements.

From compliance checks to affixing the CE mark, we manage it all.

Our streamlined process saves time and eliminates complexity.

Ensure EU regulatory compliance with precision and confidence.

Seamless market access and enhanced product credibility guaranteed.

Gain a competitive edge with our reliable support.

Contact NexorTest Technologies today to achieve hassle-free CE certification!

[calimera62]

Meme de 2024

Je suis en retard mais c'est comme pour les vœux de l'année ! On peut le faire jusqu'au 31 janvier !

Habituellement, je remplis ce meme sur LiveJournal mais ce site est de plus en plus déserté, et j'avoue moi-même ne plus trop y aller, donc j'ai décidé de le faire sur tumblr !

Voici donc mon année 2024 en fandoms et découvertes !

1. Votre fandom de l'année

Je ne sais pas s’il y a eu un fandom qui s’est démarqué mais parmi mes fandoms de l’année, ceux où je suis restée longtemps sont de vieux fandoms comme Naruto, Makai Ouji, Black Butler, Star Wars, Phineas et Ferb. J’ai aussi été pas mal dans le fandom Percy Jackson, grâce à la série Disney, mais aussi Détective Conan mais aussi Interview with the Vampire avec la saison 2 de la série. Aussi grosse surprise, et grâce à Anders, Allenkune et Bass, j’ai eu une longue période Salem’s Lot où j’ai été très productive en matière de fics et de drabbles haha.

2. Votre film préféré vu cette année

Je n’ai pas vu beaucoup de films en 2024, mais je dirais Le Menu avec Ralph Fiennes et Anna Taylor-Joy.

3. Votre livre préféré lu cette année

En roman, j’ai eu plusieurs coups de cœur mais je retiendrai surtout Le cœur de Neverland d’Isabelle Lesteplume et Trahison sanglante : Le dossier Dracula, de Mark A. Latham (un mélange Dracula et Sherlock Holmes... ça ne pouvait que me plaire !)

En manga, j’ai eu un coup de cœur pour Les carnets de l’apothicaire, mais j’ai bien aimé Deep sea aquarium Magmell

En bande-dessinée, c’est À l’école des lettres de PoPésie et Maïté Robert, mais j’ai bien aimé aussi Lore Olympus.

4. Votre album/chanson préféré écouté cette année

Majoritairement Epic the Musical qui s’est achevé le 25 décembre !

5. Votre série télé préférée vue cette année

Je n’ai pas vu de nouvelle série tv cette année, je retiendrais surtout la saison 2 d'Interview with the vampire et la saison 1 de Percy Jackson. J'ai aussi revisionné toute la série Malcolm ainsi que Desperate Housewives.

6. Votre communauté LJ préférée de l'année

7. Votre découverte de l'année en fandom

Les carnets de l’apothicaire et Lore Olympus principalement.

8. Votre plus grosse déception de l'année en fandom

Ouch, entre la révélation dans le dernier film de Détective Conan qui sort complètement de nulle part et qui change à jamais la perception d’un ship que j’adore, Our Flag Means Death qui n’est pas renouvelé pour une saison trois, Good Omens qui voit sa dernière saison transformée pour quelque chose de beaucoup plus court suite aux révélations sur Neil Gaiman (ce qui est tout à fait compréhensif, mais ça n'empêche pas la déception concernant la série)

9. Votre petit ami de fiction de l'année

Jinshi des Carnets de l'Apothicaire ou le Père Callahan :P

10. Votre petite amie de fiction de l'année

Maomao des Carnets de l’Apothicaire. Je l'adore ! Elle est tellement passionnée, délurée, intelligente, voire même cinglée, elle est formidable cette fille !

11. Votre grand moment de squee de l'année

Quelques passages dans Epic the Musical (je ne peux pas les citer, par crainte de spoiler et puis il y en a tellement ^⁾, les moments entre Percy et Poséidon dans la série Percy Jackson (je suis si faible pour les moments père-fils)

12. Le vieux fandom qui vous manque le plus

Peut-être Harry Potter/Fantastic Beasts, surtout le couple Grindeldore, peut-être aussi le fandom Kaamelott que j'ai tendance à déserter car l'omniprésence d'un ship a fini par me donner l'indigestion (pourtant, j'aimais bien ce ship).

Sinon, je ne saurais dire si ça me manque mais il faudrait vraiment que je me remette à la série What we do in the shadows, voire la reprendre depuis le début car j'ai pratiquement tout oublié !

13. Le fandom que vous n'avez pas encore essayé, mais vous en avez l'intention

Le Grand Maître de la Cultivation Démoniaque (ou Mo dao zu shi), depuis le temps que j'en entends parler ! Ça ou Heaven Official's Blessing, je vous avoue qu'entre les deux, de visu, je suis incapable de faire la différence et je ne sais pas avec lequel je vais commencer ^^;

Sinon, commencer la saga Le Seigneur des Anneaux. Depuis le temps que je dis que je vais commencer à la lire et que je ne le fais toujours pas...

14. Vos plus grandes espérances de fan pour la nouvelles année

J’ai pas mal d’attente pour le tome 41 d’Astérix mais aussi et surtout la série animée de Chabat. J’espère être conquise !!

J’aimerais des bonnes nouvelles pour la franchise Fantastic Beasts, bien que je pense que Warner Bros se penchera davantage sur la série Harry Potter.

Sinon, j'espère que le second volet du film Kaamelott me plaira (je crois qu'il sort en 2025 ?)

J'espère aussi des bonnes nouvelles pour Our Flag Means Death, que la dernière saison promise verra le jour... On croise des doigts !

Memes des autres années : 2023 - 2022 - 2021 - 2020 - 2019 - 2018 - 2017 - 2016 - 2015 - 2014 - 2013 - 2012 - 2011