The typical time cycle for applying for Class B medical device CE certification can vary depending on several factors, including the complexity of the device and the efficiency of the Notified Body. Generally, the process can take from 6 to 12 months. Here are the key stages of the review process:

1. Preparation Stage (2-4 weeks):

• Document Preparation: Compile all required technical documentation, including device descriptions, design and manufacturing information, risk management, clinical evaluation, and labeling.
• QMS Implementation: Ensure your Quality Management System (QMS) is in place and compliant with ISO 13485.

2. Application Submission (1-2 weeks):

• Submit Application: Complete and submit the application form along with all technical documentation and QMS records to the selected Notified Body.

3. Documentation Review (2-4 months):

• Initial Review: The Notified Body reviews the submitted documentation to ensure it meets the requirements of the EU Medical Device Regulation (MDR).
• Feedback: The Notified Body may request additional information or clarifications, which could extend the review time.

4. On-Site Audits (1-2 months):

• Audit Scheduling: An on-site audit of your manufacturing facility and QMS is scheduled.
• Audit Execution: The Notified Body conducts the audit, reviewing manufacturing processes, quality control measures, and adherence to the QMS.
• Post-Audit Report: The Notified Body provides a report detailing findings and any necessary corrective actions.

5. Certification Decision (1-2 months):

• Evaluation: The Notified Body evaluates the audit results and documentation review to determine compliance.
• Issuance of CE Certificate: If all requirements are met, the Notified Body issues a CE certificate, confirming that the device complies with EU regulations.

6. Post-Certification Activities (Ongoing):

• Affix CE Mark: After receiving the certificate, affix the CE mark to the device and its packaging.
• Implement Post-Market Surveillance: Continuously monitor the device’s performance and report any adverse events.

Total Time Cycle:

• Overall Duration: The total time cycle from application submission to receiving the CE certificate typically spans 6 to 12 months, depending on the specifics of the device and the Notified Body’s process efficiency.

Contact Us：

Whatsapp or Wechat：+86 15816864648；email address：hito.lin@grzan.cn