Does Your EU Regulatory Submission Stand Up to Scrutiny?

This may include missing or inadequate information related to device design, manufacturing processes, performance evaluation, risk management, clinical evidence, or post-market surveillance. The technical documentation serves as evidence of compliance with the MDR/IVDR requirements, and any deficiencies in this area can delay or hinder the certification process.

Insufficient or poorly conducted clinical studies, lack of relevant clinical data, or inadequate demonstration of clinical performance can result in deficiencies. Manufacturers must ensure that their clinical evidence addresses the intended purpose and claims of the device.

These may include inadequate implementation of quality control measures, lack of documented procedures, insufficient training and qualification of personnel, or inadequate risk management processes. Notified bodies assess the manufacturer's QMS to ensure the quality and safety of the device.

Notified bodies also assess whether the manufacturer has effective processes in place to monitor the device's performance, gather feedback from users, and address any safety or performance issues that arise after the device is placed on the market. Inadequate reporting and analysis of post-market data can result in deficiencies.

Deficiencies may include incorrect or incomplete information, lack of clarity in instructions for use, or failure to provide appropriate warnings or precautions. Manufacturers must ensure that their labeling and instructions for use meet the regulatory requirements and enable safe and effective use of the device.