We assist businesses in determining whether CE marking requirements apply to their products and identifying the relevant European regulatory framework and applicable product requirements.
Different products may be subject to different EU legislation and harmonised standards. We assist clients in identifying the requirements and standards relevant to their specific product and intended market.
We help businesses understand and coordinate the appropriate conformity assessment procedure based on the product category, applicable legislation, and level of regulatory involvement required.
Technical documentation is an important component of demonstrating product conformity. We assist businesses in preparing and organizing relevant technical files, product information, specifications, risk assessments, test reports, and supporting records.
Where product testing is required, we assist in coordinating with appropriate testing laboratories and relevant technical service providers to obtain the necessary test reports and supporting documentation.
We assist businesses in understanding and preparing the applicable EU Declaration of Conformity and ensuring that the relevant product and regulatory information is appropriately documented.
For product categories requiring third-party conformity assessment, we assist clients in coordinating with the appropriate notified body and managing the documentation and procedural requirements involved.
We provide guidance on applicable CE marking requirements and associated product information, helping businesses address the relevant compliance considerations before placing covered products on the European market.
Product compliance does not necessarily end when a product reaches the market. Businesses may have continuing obligations relating to technical documentation, product changes, corrective actions, traceability, and regulatory requirements. We assist clients in addressing applicable post-market compliance matters.
CE requirements can apply to a wide range of product categories where specific EU legislation requires CE marking. Depending on the applicable legislation, this may include products such as:
Includes machinery and equipment, certain pressure equipment, and measuring instruments.
Includes electrical and electronic products, as well as radio and telecommunications equipment.
Includes medical devices designed for therapeutic or diagnostic purposes.
Includes personal protective equipment intended to protect against risks to health or safety.
Includes toys and certain construction-related products.
The specific requirements depend on the product, its intended use, applicable EU legislation, and the market into which it is being placed.
We help businesses understand the CE requirements applicable to their particular products rather than relying on generic compliance approaches.
Our team assists clients in identifying relevant European regulatory requirements and applicable standards.
We assist in organizing technical files, declarations, test reports, risk assessments, and other relevant compliance documentation.
Where testing or third-party assessment is required, we coordinate with appropriate laboratories, notified bodies, and technical professionals.
Our approach is designed to help businesses understand and address the regulatory requirements involved in taking their products into the European market.
We can assist businesses with applicable changes, documentation updates, post-market requirements, and other continuing product compliance matters.