What is Class B medical device CE certification in the EU? How to apply?
Release time:2024-08-15 14:57:03 The author: source:
Prepare Technical Documentation: This includes detailed product specifications, risk analysis, and clinical evaluations.

Class B medical devices in the EU refer to those that are considered medium risk, such as certain diagnostic devices and some non-invasive equipment. To apply for CE certification for a Class B device, you need to follow these steps:

  1. Prepare Technical Documentation: This includes detailed product specifications, risk analysis, and clinical evaluations.
  2. Quality Management System (QMS): Implement and document a QMS compliant with ISO 13485.
  3. Choose a Notified Body: For Class B devices, you need to involve a Notified Body to assess your technical documentation and QMS.
  4. Submit Application: Provide your technical documentation and other required information to the Notified Body.
  5. Certification Process: The Notified Body will review your application and conduct audits. If everything is in order, they will issue a CE certificate.
  6. Post-Market Surveillance: After certification, maintain records and conduct post-market surveillance as required.

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