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How long does it take to obtain Class B medical device CE certification?
Release time：2024-08-15 15:36:30 The author: source:
Preparation and Documentation (1-3 months): Time to gather and prepare the necessary technical documentation and implement a Quality Management System (QMS).

The process to obtain Class B medical device CE certification generally takes 6 to 12 months. This timeline includes:

  1. Preparation and Documentation (1-3 months): Time to gather and prepare the necessary technical documentation and implement a Quality Management System (QMS).

  2. Application Submission (2-4 weeks): Completing and submitting the application form and documentation to the Notified Body.

  3. Notified Body Review (2-4 months): The Notified Body reviews your documentation and QMS, which may include an on-site audit.

  4. Certification Decision (1-2 months): The Notified Body makes a decision and issues the CE certificate.

The total time can vary based on the complexity of the device, the efficiency of document preparation, and the Notified Body’s workload.

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