Obtaining CE certification for a Class B medical device involves several structured steps to ensure compliance with the EU Medical Device Regulation (MDR) 2017/745. Here is a detailed overview of the process:

1. Prepare Technical Documentation:

• Device Description: Detailed description of the device, its intended use, and functionality.
• Design and Manufacturing Information: Design specifications, manufacturing processes, and quality control measures.
• Risk Management: Risk assessment and risk management documentation as per ISO 14971.
• Clinical Evaluation: Clinical data or literature review supporting the device’s safety and performance.
• Labeling and Instructions for Use (IFU): Ensure labeling and user manuals are compliant with MDR requirements.

2. Implement Quality Management System (QMS):

• ISO 13485 Compliance: Develop and implement a QMS that complies with ISO 13485 standards.
• Documentation: Document QMS procedures, including design control, production processes, and post-market surveillance.

3. Choose a Notified Body:

• Selection: Identify and select a Notified Body accredited to assess Class B medical devices.
• Initial Contact: Initiate contact with the Notified Body to understand their specific requirements and application process.

4. Submit Application to Notified Body:

• Application Form: Complete the application form provided by the Notified Body.
• Submit Documentation: Provide all required technical documentation and QMS records to the Notified Body.

5. Notified Body Review and Assessment:

• Documentation Review: The Notified Body reviews the submitted documentation for compliance with MDR requirements.
• Audits: The Notified Body may conduct on-site audits of your manufacturing facility and QMS.
• Additional Information: Be prepared to provide additional information or address any questions or concerns raised by the Notified Body.

6. Certification Decision:

• Evaluation Outcome: The Notified Body evaluates the findings and decides whether to grant CE certification.
• Certificate Issuance: If compliant, the Notified Body issues a CE certificate. This certificate confirms that the device meets all necessary regulatory requirements.

7. Post-Certification Activities:

• Conformity Marking: Affix the CE mark to your device, indicating that it meets EU regulatory requirements.
• Ongoing Compliance: Continue to adhere to MDR requirements, including post-market surveillance, vigilance reporting, and maintaining an up-to-date technical file.
• Renewal: Be aware of the certificate’s expiration date and prepare for renewal or recertification as required.

8. Maintain Communication with Notified Body:

• Inform of Changes: Notify the Notified Body of any significant changes to the device or manufacturing process.
• Periodic Reviews: Engage in periodic reviews or audits as required by the Notified Body.