The cycle for Class B medical device CE certification typically involves several stages, and the entire process usually spans 6 to 12 months. Here’s a breakdown of the typical cycle:

1. Preparation (2-4 weeks):

• Review Regulations: Understand the EU Medical Device Regulation (MDR) 2017/745 and relevant harmonized standards.
• Compile Technical Documentation: Gather all required documents, including device description, risk management, clinical evaluation, and labeling.
• Implement QMS: Develop and implement a Quality Management System (QMS) compliant with ISO 13485.

2. Application Submission (1-2 weeks):

• Complete Application Form: Fill out and submit the application form provided by the Notified Body.
• Submit Documentation: Provide all necessary technical documentation and QMS records.

3. Notified Body Review (2-4 months):

• Documentation Review: The Notified Body reviews the submitted documentation for compliance with MDR requirements.
• On-Site Audit: The Notified Body may conduct an on-site audit to assess manufacturing processes and QMS.
• Response to Queries: Address any additional questions or requests for further information from the Notified Body.

4. Certification Decision (1-2 months):

• Evaluation: The Notified Body evaluates the findings from the documentation review and audit.
• Issuance of CE Certificate: If compliant, the Notified Body issues a CE certificate, confirming that the device meets EU regulations.

5. Post-Certification Activities (Ongoing):

• Affix CE Mark: Once certified, affix the CE mark to your device and its packaging.
• Post-Market Surveillance: Implement a system to monitor the device’s performance and report any adverse events.

6. Renewal and Updates:

• Certification Renewal: Monitor the certificate’s validity and prepare for renewal or recertification as needed.
• Notify Changes: Inform the Notified Body of any significant changes to the device or manufacturing processes.