Consulting on CE Declaration of Conformity and Type Approval

Description

Our Services

We guide you through the entire process and, upon request, manage individual project phases.

• Product concept / development – we assess whether relevant regulations are met – if not, we assist you in engineering the product to reliably comply with all requirements.
• We facilitate your FMEA development and assist in evaluating failure risks.
• We assist you in defining test and inspection plans, as well as establishing test types, inspection frequencies, and sample sizes for subsequent series surveillance.
• We integrate in-line series product testing into your PCP – production control plan – ensuring audit compliance and reproducibility.
• We connect you with qualified testing laboratories – providing at least 3 distinct options. Utilizing our network, we can secure earlier testing dates and achieve more favorable pricing.
• We prepare and oversee product testing within the scope of the CE Declaration of Conformity or type approval to identify potential weaknesses at an early stage.
• We plan your series surveillance for CE and CoP, establishing structured data evaluation including trend analyses.
• We establish evaluation criteria for the early detection of potential non-conformities, implement a corresponding escalation process, and set up a framework for authority notifications and corrective actions.
• We establish structured reporting procedures.

Key Considerations for Your Business

Type Approval – Who is Qualified and Authorized to Advise You?

For products subject to mandatory type approval, technical services conduct testing on your behalf or on behalf of the approval authority to obtain type approval based on the generated test reports.

Have you ever wondered why technical services often provide brief and generic responses to your inquiries? It is essential to recognize that a technical service is legally prohibited from providing consulting services if they perform your type approval testing.

Simply contact us instead. We can coordinate all technical details directly with the technical service and advise you on how to optimize your product design and prepare for type approval with minimal effort, ensuring compliance on the first attempt.

An added benefit: Our team brings diverse industrial backgrounds and extensive experience in preparing the required documentation. In contrast, personnel at technical services typically only review and evaluate completed submissions. This is an objective distinction—each entity specializes in its respective core competence.

Declaration of Conformity

Virtually all products are subject to concrete statutory requirements. Whether dealing with technical devices, machinery and equipment, bicycles or e-bikes, toys, textiles, or cosmetics—a variety of laws, regulations, and directives must be observed.

Key examples include the Machinery Regulation, the Low Voltage Directive, and the Electromagnetic Compatibility Directive. Compliance with these requirements is indicated by the “CE mark”.

Upon successful conformity assessment, your EU Declaration of Conformity grants your products market access within the European Union. Affixing the CE mark—the manufacturer’s sole declaration of compliance—demonstrates to market surveillance authorities and your customers that your products satisfy all applicable European directives.

Product safety

General product safety requirements apply to all products, even if they do not fall under one of the numerous harmonization regulations. In particular, the General Product Safety Regulation ("GPSR"), which came into force in December 2024, must be applied here.

Contact

Require a customized proposal or have questions? Simply contact us.