For medical devices certified under the EU CE marking, periodic updates and reviews are crucial to ensure ongoing compliance with regulatory requirements and to maintain certification validity. Here are the key standards and procedures to consider for periodic updates of EU CE certification:

Standards and Guidelines:

1. ISO 13485:2016 (or EN ISO 13485:2016):

   • Quality management systems – Requirements for regulatory purposes. Maintain and update your Quality Management System (QMS) to ensure continued compliance with ISO 13485 standards.

2. ISO 14971:2019:

   • Application of risk management to medical devices. Conduct periodic risk assessments and update risk management files as necessary to address any identified risks or changes.

3. Clinical Evaluation (MDR specific):

   • Conduct regular reviews and updates of clinical evaluation reports to incorporate new clinical data, post-market surveillance findings, and changes in device design or intended use.

4. Post-Market Surveillance (PMS) and Vigilance:

   • Continuously monitor and review post-market surveillance data and vigilance reports to identify trends, potential issues, and areas for improvement. Implement corrective and preventive actions (CAPA) as necessary.

5. Labeling and Instructions for Use (IFU):

   • Regularly review and update labeling and IFU to ensure they remain accurate, up-to-date, and compliant with EU regulations. Include the CE mark and any required symbols or warnings.

Procedures for Periodic Updates:

1. Internal Audits:

   • Conduct regular internal audits of your QMS, technical documentation, and regulatory compliance processes to identify gaps, non-conformities, or areas needing improvement.

2. Documentation Updates:

   • Maintain and update technical documentation, including design files, risk management files, clinical evaluation reports, and labeling, to reflect changes in device specifications, manufacturing processes, or regulatory requirements.

3. Regulatory Monitoring:

   • Stay informed about updates to EU medical device regulations, guidelines, and standards. Monitor regulatory developments to ensure timely adaptation and compliance with new requirements.

4. Notified Body Interaction:

   • Engage with your Notified Body as needed for guidance on updates, changes, or new requirements. Notify the Notified Body of significant changes to the device or manufacturing process that may impact certification.

5. EUDAMED Database (MDR specific):

   • Prepare for registration and submission of required data in the EUDAMED database, once operational, for ongoing regulatory compliance and market surveillance purposes.

6. Training and Awareness:

   • Provide ongoing training to personnel involved in the lifecycle management of your medical device. Ensure they are aware of regulatory updates, compliance requirements, and their responsibilities.

Compliance with MDR Requirements:

Under the Medical Devices Regulation (MDR), additional considerations for periodic updates include:

• Unique Device Identification (UDI): Ensure compliance with UDI requirements and prepare for registration in EUDAMED.
• Summary of Safety and Clinical Performance (SSCP): Update and maintain the SSCP with current clinical data and post-market surveillance information.