Notified Body for CE Certification
Accreditation in Progress – ISO/IEC 17065
What is a Notified Body?
A Notified Body is an independent and qualified entity recognized by the European Union to certify the compliance of products with essential requirements of EU directives. As a Notified Body, COMEX is authorized to issue CE conformity attestations for Personal Protective Equipment (PPE), ensuring that your products meet the required safety and performance standards and are eligible for distribution within the European market.
Why Certify Your Products with a Notified Body?
- ✓Access to the European Market: CE certification issued by a Notified Body allows your equipment to freely enter the European market by demonstrating compliance with required safety and quality standards.
✓Regulatory Compliance: Certification by a Notified Body is mandatory for Category II and III PPE and ensures adherence to European regulations, crucial for user safety.
✓Recognition of Equipment Safety: CE certification by a Notified Body strengthens user and industrial partner confidence, proving that equipment meets the highest safety standards.
As a Notified Body, COMEX is your trusted partner to ensure your equipment’s compliance with European regulations and to facilitate market integration on an international scale.
CE Certification and Marking Process
CE certification is based on a rigorous process that ensures the tested products comply with European regulatory requirements.
Equipment Compliance Verification
- ✓Based on tests conducted by our ISO/IEC 17025 laboratory (accreditation in progress), COMEX verifies the compliance of equipment with European standards.
EU Type Examination Certificate (Module B)
- ✓Following verification, our Notified Body issues the CE Type Examination Certificate, an official document authorizing the CE marking of tested equipment..
Annual Production Audits (Module C2)
- ✓ For Category III PPE, COMEX performs annual production audits (Module C2) to ensure that each production batch consistently meets required safety standards.
Module B Review
- ✓ When the EU Type Examination Certificate expires or when a modification is made to the PPE, COMEX is capable of reviewing the certificate to ensure continued compliance.
Scope of COMEX as a Notified Body
The COMEX Notified Body operates in various industrial sectors to certify a wide range of Personal Protective Equipment (PPE), including diving gear and hyperbaric devices.
Our certification services cover:
- ✓PPE for underwater diving
- ✓PPE for buoyancy aid
- ✓PPE for drowning prevention
Our Notified Body relies on test results from our ISO/IEC 17025 laboratory (accreditation in progress) to issue certifications.
For detailed information on the equipment and applicable standards, visit our dedicated Laboratory Testing page to understand how tests are conducted prior to certification.
Expertise and Support
Our Notified Body supports you throughout the certification process, from compliance verification to issuing the CE Type Examination Certificate. We collaborate closely with manufacturers to ensure every piece of equipment meets current requirements.
Our expertise also allows us to guide industries seeking to develop innovative products. Whether in the design phase or preparing for market entry, COMEX is available to help you meet regulatory requirements and develop tailored protocols for your products.
The Notified Body Team
Frequently Asked Questions (FAQ) – Notified Body
What is a Notified Body?
A Notified Body is an independent entity designated by the European Union to evaluate product compliance with safety requirements under European regulations. As a Notified Body, COMEX is authorized to issue CE certification for Personal Protective Equipment (PPE).
Why do I need CE certification for my equipment?
CE certification is mandatory for equipment intended for the European market, particularly Category II and III PPE. It demonstrates compliance with required safety and performance standards, ensuring free movement of your products within the EU market.
What types of equipment can COMEX certify?
COMEX specializes in certifying PPE for professional and recreational underwater diving, buoyancy aid PPE, and drowning prevention PPE.
What is the CE certification process with COMEX?
Once samples and technical documentation are received, testing is conducted at the COMEX laboratory. A thorough review of all documentation is completed before issuing the EU Type Examination Certificate for CE marking. For Category III PPE, COMEX also performs annual production audits (Module C2) to ensure ongoing compliance.
How can I obtain a quote for CE certification?
To request a quote or obtain additional information about CE certification for your products, contact our team via our contact form. We will guide you through the steps of the process and provide details on the required documents.
Would you like to contact our Notified Body?
Fill out our form!
The COMEX team will get back to you as soon as possible.
