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EC Design-Examination Certificate Directive 93/42/EEC on Medical Devices, Annex II, section 4. Design Approval no. 3144-2013-CE-IND-D. ... 5/31/2016 8:43:37 AM ...
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How to fill out ec design-examination certificate
How to Fill Out EC Design-Examination Certificate:
01
Firstly, gather all relevant information and documents related to your product design. This typically includes technical specifications, drawings, and descriptions.
02
Fill in the basic details on the certificate, such as the name and address of the manufacturer or applicant, as well as the contact information.
03
Provide a brief description of the product, including its intended purpose and any relevant technical features.
04
Indicate the harmonized standards or technical specifications that have been applied to the product design.
05
Include any test reports or evaluations that have been conducted to verify the conformity of the product with applicable regulations and standards.
06
If applicable, provide information on any notified bodies or conformity assessment bodies involved in the design examination process.
07
Clearly state the conformity assessment procedure used for the product, such as if it has undergone a full quality assurance (Module C) or a design examination (Module B).
08
Sign and date the certificate, ensuring that it is done by an authorized representative of the manufacturer or applicant.
Who Needs EC Design-Examination Certificate:
01
Manufacturers or applicants who wish to place products on the market within the European Union (EU) or the European Economic Area (EEA) may require an EC design-examination certificate.
02
Specific industries that commonly require this certificate include machinery, electrical equipment, medical devices, and construction products.
03
The EC design-examination certificate demonstrates that the design of the product meets the essential requirements outlined in the relevant EU directives or regulations.
04
It is a crucial document to obtain CE marking, which indicates that the product complies with EU safety, health, and environmental protection standards.
05
Importers, distributors, and authorized representatives may also need access to the EC design-examination certificate to ensure compliance and to fulfill their obligations within the supply chain.
Note: It is important to consult the specific regulations and directives relevant to your product category to determine if an EC design-examination certificate is required and to follow the appropriate procedures for obtaining and filling out the certificate.
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What is ec design-examination certificate?
The ec design-examination certificate is a document that verifies the design of a product complies with relevant regulations and standards.
Who is required to file ec design-examination certificate?
Manufacturers or importers of products are required to file the ec design-examination certificate.
How to fill out ec design-examination certificate?
To fill out the ec design-examination certificate, the manufacturer or importer must provide detailed information about the product design and compliance with regulations.
What is the purpose of ec design-examination certificate?
The purpose of the ec design-examination certificate is to ensure that products meet safety and quality standards before being placed on the market.
What information must be reported on ec design-examination certificate?
The ec design-examination certificate must include details about the product design, compliance testing, and the manufacturer's contact information.
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