CE Marking Process
ACTORS
CE marking is different depending on who you are. There are four different actors involved in the process.
Natural or legal person that has the product designed or manufactured and places it on the market under his own name.
Legal entity established in the EEA that performs the CE marking process in the name of a manufacturer established outside the EEA.
Natural or legal person established in the Union who places a product from a third country on the EU market
Natural or a legal person in the supply chain, other than the manufacturer or importer, who makes a product available on the market.
MANUFACTURER
AUTHORIZED REPRESENTATIVE
IMPORTER
DISTRIBUTOr
STEPS
The CE marking process for medical devices has been widely divided into six steps. The following steps should be followed by the manufacturer (and an Authorized representative, if applicable). All six steps can be applied to any product under the scope of CE marking (not only medical devices).
Identify the EU requirements for your product. Which means to know which legislations (directives) apply to your device.
Categorize the device based on level of risks. Classify the product in accordance to the legislation.
Conformity assessment route and Notified Body. According to the type and class of product, decide which conformity process you want to undergo and, if a third party is required for assessment, choose an appropriate one.
Identify and Meet Essential Requirements. Test the product. Based on the applied directive, check if your device meets the essential requirements.
Technical Documentation. Gather all information necessary (according to legislation and class of device) in a Technical File or Design Dossier.
Declaration of Conformity and Affixing CE mark. The last step is to write a document stating that the product meets all legal requirements and to affix the CE marking logo in your product.
START THE PROCESS
Now that you know what CE marking is and how necessary it is, you need to apply all six steps in the most specific way. CEEASY provides the most intuitive guiding tool on CE marking for medical devices.
The process is based on the six defined steps and it is shown as the pipeline below. Go step by step. Completed steps are shown in green, the current step is in blue and steps to come are in grey (as shown below, as the process has not been started yet).
Before starting the process, CEEASY highly recommends you to perform a previous step.
ATTENTION
Write down a clear and brief description of the device. Including:
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What it is
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What it is made of
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How it works
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Intended use, user and conditions