What is CE Mark
- shows that the manufacturer has checked that these products meet EU safety, health or environmental requirements
- is an indicator of a product’s compliance with EU legislation allows the free movement of products within the European market.
According to Medical Device Directive 93/42/EEC (MDD) , 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 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
It depends on the categories of product 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 .