CE Mark 認證

【CE Mark】| 5 Steps to get CE Mark

CE Mark registration

If the medical device is manufactured in the EU country, the manufacturer can apply directly to the local government agency (Competent Authority). If the medical device is manufacture outside of EU, the EU authorized Representative assists the manufacturer to apply CE Registration.

Application for CE Mark registration process

1) Determine the relevant directives and harmonized standards and other requirements that the product complies with
2) Determine whether product classification requires third-party organization to participate in verification
3) Prepare Technical Files required by the preliminary directive
4) European Union Authorised Representative (Europe Union Authorised Representative) to register the local medical equipment government department
5) Affix the CE mark on your product and make an EC Declaration of conformity