Yes, an annual review is generally required for EU CE certification of Class C medical devices. Here’s what it typically involves:

Annual Review and Maintenance

1. Notified Body Surveillance Audits

   • Frequency: The Notified Body conducts periodic surveillance audits, often annually, to ensure ongoing compliance with the EU Medical Device Regulation (MDR) and the quality management system (QMS).
   • Purpose: These audits assess whether the manufacturer continues to meet regulatory requirements and maintains the QMS.

2. Post-Market Surveillance

   • Ongoing Monitoring: Manufacturers must continuously monitor the device’s performance and safety once it is on the market.
   • Reporting: Regular updates and reports on device performance, incidents, and corrective actions must be provided as part of post-market surveillance.

3. Regulatory Updates

   • Compliance with Changes: Manufacturers need to stay informed about updates to the MDR and other relevant regulations, ensuring their device remains compliant with any new requirements.

4. Documentation Updates

   • Technical Documentation: Regular updates to the technical documentation may be required to reflect changes in the device, manufacturing processes, or regulatory requirements.