IMDRF guidance details when regulators should share postmarket surveillance reports

The International Medical Devices Regulators Forum (IMDRF) has issued guidance on when and how regulators should share information about the potential risks of certain medical devices in the postmarket setting. The system to submit such reports is currently limited to regulators in its management committee.

On 1 April, IMDRF’s National Competent Authority Report (NCAR) Exchange Program Working Group published guidance on when regulators should consider exchanging information about products that may pose serious public health risks. The guidance also outlines the procedures and forms regulators should use to share the information, as well as the requirements IMDRF members must meet to participate in the NCAR Exchange Program.

“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.

The NCAR Exchange Program is limited to IMDRF Management Committee (MC) Regulators. The annex of the guidance includes 27 countries and the European Commission that are a part of NCAR.

“IMDRF MC Regulators who to date have not been involved in the GHTF NCAR Exchange Program shall inform the Management Committee of their wish to join the IMDRF NCAR Exchange,” said IMDRF. “Applicants will be required to review implementation materials on the key elements of the exchange, the definitions and confidentiality before joining the NCAR Exchange Program.”

“IMDRF MC Regulators who intend to participate in the NCAR Exchange Program will need where possible to have confidentiality arrangements in place with other participating NCAs and the NCAR Secretariat,” the group added.

The guidance annex also includes a form that regulators can use to submit their reports. IMDRF notes that the forms should be completed in English, include a point of contact, be accurate and complete, and include all relevant information. The group also said the form should not be used to report single incidents unless the incidents have clear implications for public health.

"In such cases, the implied recommendation is for other NCAs to be aware and take such local actions they find appropriate," said IMDRF. "If the NCAR involves a specific manufacturer’s device, then the manufacturer or authorized representative may be consulted regarding the NCARs content and distribution of the device prior to it being sent – preferably by providing a copy for the manufacturer or authorized representative to comment on."

"This will help to ensure the accuracy, particularly the technical content, of the NCAR," the group added. "An appropriate timeframe for receiving manufacturer’s comments should be communicated."

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IMDRF guidance details when regulators should share postmarket surveillance reports

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