Yes, an annual review is generally required as part of the ongoing compliance for EU CE certification of Class D medical devices. Here’s what this entails:

1. Annual Surveillance Audits

• Notified Body Audits: The Notified Body will conduct periodic surveillance audits, typically on an annual basis, to ensure that the manufacturer continues to comply with the EU Medical Device Regulation (MDR) 2017/745 and ISO 13485:2016. These audits assess the effectiveness of the Quality Management System (QMS) and check for any non-conformities.

2. Post-Market Surveillance

• Ongoing Monitoring: Manufacturers are required to implement and maintain a post-market surveillance system to monitor the device’s performance and safety in the market. This includes regular reviews of adverse events, device performance, and user feedback. The results of this surveillance should be reviewed and updated as part of the annual review process.

3. Updating Technical Documentation

• Documentation Updates: Manufacturers need to regularly update the technical documentation, including risk management, clinical evaluations, and performance testing, based on new data, technological advancements, and regulatory changes. This ensures ongoing compliance and addresses any emerging issues.

4. Regulatory Changes

• Compliance with Updates: The EU MDR may be updated or amended over time. Manufacturers must ensure that their devices continue to meet the latest regulatory requirements and adapt their processes and documentation accordingly.

5. Quality Management System Maintenance

• Continuous Improvement: The QMS must be maintained and improved based on audit findings, feedback, and changes in regulations or industry standards. Regular internal audits and management reviews are part of maintaining the QMS.