New IMDRF guidance covers postmarket surveillance report sharing

The International Medical Devices Regulators Forum (IMDRF) has issued guidance on when and how regulators should share information about the potential postmarket risks of certain medical devices.

On 1 April, IMDRF’s National Competent Authority Report (NCAR) Exchange Program Working Group published guidance titled ‘Medical Devices: Post Market Surveillance National Competent Authority Report Exchange Criteria and Report Form’ covering when regulators should consider exchanging information about products that may pose serious public health risks.

“The NCAR Exchange Program will be used to exchange information relating to significant concerns or potential trends that individual authorities have observed in their jurisdictions but have not yet resulted in recalls or Field Safety Corrective Actions (FSCAs),” said IMDRF.

IMDRF states that reportable events about medical devices under the NCAR Exchange Program include situations where a product has led to or is highly likely to lead to an unanticipated serious public health threat. That could include situations where the device has caused the death or serious injury to the user. It could also include situations where regulators suspect the product could lead to death or serious injury if the incident happens again.

Copies of the guidance can be accessed from here.