What is CE Marking
The Conformitè Europëenne (CE) Mark is defined as the European Union’s (EU) mandatory conformity marking for regulating the goods sold and is manufacturers’ declaration that the product meets EU standards for health, safety, and environmental protection within the European Economic Area (EEA).
The mark consists of the CE logo and, if applicable, the four digit identification number of the Notified Body involved in the conformity assessment procedure.
Not all products must bear the CE marking. Only those product categories subject to specific directives that provide for the CE marking are required to be CE marked.
CE marking applies to products, ranging from electrical equipment to toys and from civil explosives to medical devices. The full list of these product categories is below:
- active implantable / in vitro diagnostic medical devices
- medical devices
- personal protective equipment
- and other different equipments
The CE marking is not required for items, for example:
- cosmetics and foodstuffs
According to Regulation (EU) 2017/745 on Medical Devices (MDR) and Regulation (EU) 2017/746 on In-Vitro Diagnostic Devices (IVDR) , the EU manufacturer can apply directly to the local government agency (Competent Authority).
If the medical device is manufactured outside of EU, the EU Authorized Representative assists the manufacturer to apply.
Application for CE Mark registration process
- Determine the regulations / directives and harmonized standards and other requirements that the product complies with
- Determine whether product classification requires third-party notified body to participate in verification
- Prepare Technical files required by the preliminary directive
- Contact European Union Authorised Representative to register the local medical equipment government department
- Affix the CE mark & EU Authorized Representative information on your product and make an EC Declaration of conformity.
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Frequent Asked Question
The duration depend on product category and product complexity.
It depend on the product category and product complexity, availability of testing report, production control and ISO Certification.
Absolutely Yes. In general, ISO Consultant will help technical files and liaise with EU Representative guide your company to prepare until getting CE Mark.
In general, the company can put the CE Mark on the packing & product after completion of CE registration .