Yes, annual review or periodic review is indeed required for EU CE certification of medical devices. This requirement ensures that the manufacturer continues to maintain compliance with regulatory standards and that the device remains safe and effective throughout its lifecycle on the market.

Key Points About Annual Review for EU CE Certification:

1. Purpose: The annual review is conducted to assess whether the medical device continues to meet the essential requirements set out in the Medical Devices Directive (MDD) or the Medical Devices Regulation (MDR). It ensures ongoing compliance with regulatory requirements.

2. Documentation Review: Manufacturers must review and update technical documentation, including risk management files, clinical evaluation reports, and any changes made to the device or manufacturing processes since the initial certification.

3. Post-Market Surveillance (PMS): Manufacturers are required to maintain a post-market surveillance system to collect and evaluate data on the device's performance, including feedback from users, complaints, and adverse events.

4. Update of Notified Body: The manufacturer must inform the Notified Body about any changes to the device or manufacturing process that could affect its compliance with regulatory requirements. This includes significant changes that may require reassessment or re-certification.

5. Duration and Frequency: The specific requirements for annual review may vary depending on the device classification, risk level, and applicable regulations (MDD or MDR). Notified Bodies may also require periodic updates or reviews based on risk assessments.

6. Continuous Improvement: The annual review process encourages manufacturers to implement continuous improvement processes to enhance the safety, performance, and quality of their medical devices.