CE Certification, Marking Services for products entering the European market. Ensure EU compliance, trusted compliance, testing & documentation solutions, EU safety, health & environmental protection standards,

Accredium Certifications: Your Pathway to the EU Market

(Logo: Accredium Certifications & Assessment, accompanied by a notable CE Mark symbol)

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Achieve CE Marking with an EU Notified Body – Easily with Accredium
Open the Doors to the European Union Market for Your Products.

 

 

For many products, possessing the CE Mark is more than just a designation; it is a legal requirement for market access within the European Economic Area (EEA). If your product is subject to specific EU Directives that necessitate the involvement of a Notified Body, obtaining the CE Mark is a complex yet vital process.

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Accredium Certifications serves as your knowledgeable guide and facilitator, linking you with reputable EU Notified Bodies to ensure your products adhere to all crucial health, safety, and environmental standards and secure the CE Mark effectively.

 

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Request a Free CE Consultation Today!

 

[Section 1: Grasping CE Marking & Notified Body Products]

 

What is CE Marking and Why is a Notified Body Necessary?
The CE Mark (Conformité Européenne) indicates that a product complies with EU legislation concerning health, safety, and environmental protection. It represents a declaration by the manufacturer that their product fulfills the relevant EU Directives and Regulations.

 

For specific categories of products (such as medical devices, complex machinery, pressure equipment, construction products, personal protective equipment, ATEX equipment, toys, etc.), the associated risks are considered sufficiently high to warrant a third-party conformity assessment. This evaluation must be conducted by an EU Notified Body – an independent entity designated by an EU Member State to assess the conformity of particular products prior to their market release.

 

Products generally necessitating Notified Body involvement include:

- Medical Devices (particularly those in higher risk categories)
- Pressure Equipment
- Machinery (certain varieties)
- Personal Protective Equipment (PPE)
- Construction Products
- ATEX Equipment (for explosive environments)
- Various types of Electrical Equipment
- Measuring Instruments

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Accredium Certifications makes this process more straightforward for you:

- Strategic Connection with EU Notified Bodies: We utilize our established network and relationships with credible, accredited EU Notified Bodies to match your product with the correct assessment partner. This conserves your valuable time and diminishes the risk of errors.
- Thorough Gap Analysis: Our specialists conduct an initial evaluation to determine which EU Directives / Regulations are applicable to your product and to identify any deficiencies in your existing documentation or product design concerning essential requirements.
- Assistance with Technical File Compilation: We assist you in creating the complete Technical File (or

Technical Documentation), which is a required document demonstrating your product's compliance, including design schematics, test results, risk assessments, and user manuals.
- Identification of Standards & Guidance on Testing: We help you find the harmonized European standards pertinent to your product and inform you about required testing (such as electrical safety, EMC, performance, mechanical strength) to be conducted at accredited labs.
- Support for Risk Assessments: We aid in performing comprehensive risk assessments as mandated by the directives to ensure that all potential hazards are recognized and addressed.
- Selection of Conformity Assessment Modules: We guide you in choosing the suitable conformity assessment module (e.g., Module B - Type Examination, Module D - Production Quality Assurance, Module H - Full Quality Assurance) in collaboration with the Notified Body.
- Post-Certification Assistance: We provide advice on maintaining compliance, managing changes, and preparing for surveillance audits to ensure that your CE Mark remains valid.