After obtaining EU CE certification for your medical device, there are several regulations and ongoing requirements to comply with to maintain certification and ensure continued market access within the European Economic Area (EEA). Here are the key regulations and requirements:

1. Post-Market Surveillance (PMS):

• Requirement: Establish a robust post-market surveillance system to monitor the performance and safety of your device once it is on the market.
• Activities: Continuously collect and evaluate data on device performance, including feedback from users, complaints, adverse events, and field safety corrective actions (recalls).
• Responsibilities: Analyze trends, implement corrective and preventive actions (CAPA) as necessary, and report serious incidents to competent authorities.

2. Vigilance Reporting:

• Requirement: Report serious incidents and field safety corrective actions (recalls) to competent authorities in accordance with EU regulations.
• Responsibilities: Maintain records of vigilance activities, respond promptly to requests from authorities, and cooperate with investigations and market surveillance activities.

3. Quality Management System (QMS):

• Requirement: Maintain a QMS that complies with ISO 13485:2016 (or EN ISO 13485:2016) standards throughout the device lifecycle.
• Responsibilities: Conduct regular internal audits, manage documentation, and ensure ongoing compliance with regulatory requirements.

4. Labeling and Instructions for Use (IFU):

• Requirement: Ensure that labeling and IFU remain accurate, up-to-date, and compliant with EU regulations.
• Responsibilities: Include the CE mark on all labeling and packaging. Update labeling and IFU as needed to reflect any changes in device specifications or regulatory requirements.

5. Changes and Modifications:

• Requirement: Assess and document any changes to the device design, manufacturing process, or intended use to determine if they require notification or new certification.
• Responsibilities: Submit notifications or applications for amendments to the Notified Body or competent authority as required under EU regulations.

6. Clinical Data and Performance Monitoring:

• Requirement: Maintain clinical data supporting the safety and performance of your device.
• Activities: Update clinical evaluation reports as necessary based on post-market surveillance findings, new clinical evidence, or changes in device design or manufacturing.

7. Compliance with Additional MDR Requirements:

• Unique Device Identification (UDI): Comply with UDI requirements under the Medical Devices Regulation (MDR), including registration in the EUDAMED database (once operational).
• Summary of Safety and Clinical Performance (SSCP): Prepare and maintain an SSCP summarizing clinical data and post-market surveillance information.

8. Economic Operator Responsibilities:

• Requirement: Fulfill responsibilities as an economic operator under EU regulations, including record-keeping, responding to requests from authorities, and cooperating with market surveillance activities.

9. Regulatory Updates:

• Requirement: Stay informed about changes and updates to EU medical device regulations, guidelines, and standards.
• Responsibilities: Adapt processes, documentation, and compliance strategies to align with new regulatory requirements or interpretations.

10. Training and Awareness:

• Requirement: Ensure that personnel involved in the manufacturing, distribution, and post-market surveillance of your device are trained on regulatory requirements, vigilance reporting, and quality management practices.

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