[accordion_item title=”Introduction” open=”false”]
Despite what many people believe, a manufacture does not “get” the CE marking from a third party certification body or a European or national authority. The manufacturer affixes the CE marking in his own right and is allowed to do so when all requirements are fulfilled. A test or certification body maybe involved in the process merely as a service provider. However, the body will not take over responsibility for CE compliance. Responsibility for CE compliance will always remain with the manufacturer (or private labeler).

The CE marking rules typically require the following steps to be fulfilled before the CE marking may be affixed:
[icon_list_item type=”check”]Determine the applicable CE directives/regulations;[/icon_list_item]
[icon_list_item type=”check”]Identify the applicable European harmonized standards;[/icon_list_item]
[icon_list_item type=”check”]Identify which essential requirements of the CE directive/regulations apply to the product;[/icon_list_item]
[icon_list_item type=”check”]Identify which requirements of the European harmonized standards apply to the product;[/icon_list_item]
[icon_list_item type=”check”]Conduct and document the conformity assessment against the essential requirements and the requirements from the standards (this may entail visual inspection, testing etc.);[/icon_list_item]
[icon_list_item type=”check”]Machinery and medical devices require to be submitted to a risk analysis;[/icon_list_item]
[icon_list_item type=”check”]Provide the user with the information required to use the product safely (typically user manual, installation instruction, warning labels etc.);[/icon_list_item]
[icon_list_item type=”check”]Ensure consistency of production, thus proving the assessed sample and the production are identical;[/icon_list_item]
[icon_list_item type=”check”]Compile a Technical File (or sometimes called “technical documentation”) of all documents that are necessary to show compliance with all relevant requirements;[/icon_list_item]
[icon_list_item type=”check”]Draw up and sign a Declaration of Conformity (for construction products a Declaration of Performance);[/icon_list_item]
[icon_list_item type=”check”]Affix the CE marking;[/icon_list_item]
[icon_list_item type=”check”]Continuously monitor developments related to CE directives/regulations and European harmonized standards. Apply new rules and amendments where appropriate.[/icon_list_item]
[accordion_item title=”Paid Services By Trusted Consultants and Labs” open=”false”]
Though its netwerk of trusted consultants and test laboratories can support you with the following services:
[icon_list_item type=”check”]Gap Analysis: a) which directives and standards apply; b) where do you stand in terms of CE compliance and c) which steps your company will still need to take;[/icon_list_item]
[icon_list_item type=”check”]Technical File Compilation;[/icon_list_item]
[icon_list_item type=”check”]Technical File Review (review by an expert of existing Technical Files or files you compiled yourself);[/icon_list_item]
[icon_list_item type=”check”]Risk analysis;[/icon_list_item]
[icon_list_item type=”check”]Conformity Assessments and testing;[/icon_list_item]
[icon_list_item type=”check”]User manual design and review.[/icon_list_item]
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[accordion_item title=”On-line Consulting Session” open=”false”]
When you need top-level professional input on (setting up) your CE marking projects, the way to effectively perform the conformity assessments in your company, how to deal with vendors and distributors and how intricately the pieces fit together, this is your best choice, especially when your questions stretch far beyond compliance of a single product.

The 1 hour coaching/consulting session will allow in-depth discussion of your CE marking needs. The call is digitally recorded and sent to you in MP3 afterward.

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[accordion_item title=”Leave A Voice Message” open=”false”]You can also leave us a voicemail with your question, and it may be answered during one of our Q&A Sessions.
Please, only ask one question and keep it to under 60-90 seconds if you want to make it on the show.

How to Leave Us a Message

Click on the “Send Voicemail” button below, and follow instructions presented on the screen.

Record Your Voice Message
Click the Button and Record Your Voice Message


Record Your Voice Message
Click the Red Button and Record Your Voice Message


1. You need a microphone to record your message and speakers or headphones to listen back to your message.

2. Open your message by stating your name and briefly mention your company/website and then ask your question.
Note: By recording a message here you grant us permission to use your question in one of our future shows. The decision to use all or a portion of your question will be at our full discretion. Not all questions can be accepted.[/accordion_item]