【EXPERT Q&A】Is it easy to apply for the EU CE certification?
June 28, 2024
Source: drugdu
128
Drugdu.com expert's response:
CE certification is a certification system established by the European Union to ensure the safety of products for people, animals, and objects. For companies that want to export their products to EU member states, CE certification is essential.
From a process perspective, CE certification is not complicated, mainly including filling out an application form, providing product information, sending samples for testing, and obtaining a certificate or report after passing the test. The entire process is usually completed within 5-7 working days. Therefore, from an operational level, CE certification is relatively easy to apply for.
However, it should be noted that the preparation of technical documents involved in CE certification is relatively cumbersome, including but not limited to the product name, model, instruction manual, safety design documents, technical conditions, electrical schematics, etc. Enterprises need to ensure that these documents are complete, accurate, and comply with relevant EU standards.
Copyright©2024 Ddu. All rights reserved.
Read more on
- 【EXPERT Q&A】What are the content requirements of the medical device Post-marketing Supervision Plan (PMS Plan) required by the EU CE? December 20, 2024
- 【EXPERT Q&A】Can imported medical devices be commissioned to domestic third party production? December 18, 2024
- 【EXPERT Q&A】FDA small business application, what are the tips and guidelines? December 16, 2024
- 【EXPERT Q&A】How to select the boundary value of reference interval of in vitro diagnostic reagent product? December 13, 2024
- 【EXPERT Q&A】Do I need to obtain authorization for the same type of medical device information? December 11, 2024
your submission has already been received.
OK
Subscribe
Please enter a valid Email address！
Submit
The most relevant industry news & insight will be sent to you every two weeks.
