New Edition of IMDRF-NCAR Document WG/N14 Strengthens International Cooperation on Medical Device Safety
The International Medical Device Regulators Forum (IMDRF) has published the fifth edition of the IMDRF-NCAR WG/N14 document, which strengthens the sharing of information on medical device safety between competent authorities at a global level. This update aims to improve the response to adverse incidents, promoting more effective, transparent and aligned regulation between different countries.
The new edition of the document establishes stricter guidelines for the communication and management of National Competent Authority Reports (NCARs), ensuring that incidents related to medical devices are analyzed and communicated efficiently. The harmonization of these practices allows for faster and more coordinated action among the authorities involved, reducing risks and reinforcing patient safety.
Main Changes in the New Edition of IMDRF-NCAR WG/N14
Clearer and more objective selection criteria for NCARs, ensuring that only relevant notifications are shared;
Reinforcement of data protection and confidentiality requirements, ensuring the security of manufacturers' and patients' sensitive information;
Broadening the involvement of competent authorities, promoting a more comprehensive and efficient collaboration network;
Improved definition of notification and response procedures, providing greater uniformity in the approach adopted by the different countries.
The implementation of these guidelines will have a direct impact on manufacturers and distributors of medical devices, who will have to ensure compliance with the new notification and response requirements with the competent authorities.
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