IMDRF Clarifies When Authorities Can Share Confidential Information

The International Medical Device Regulators Forum released final guidance that lays out procedures for sharing confidential postmarket surveillance for medical devices among regulators.

The guidance covers criteria to be used for deciding when to exchange information, procedures to follow, requirements for IMDRF members participating in the National Competent Authority Reporting (NCAR) exchange program, and what forms to use for exchanging information.

The forum’s National Competent Authority Report Working Group released the final guidance following the IMDRF meeting in September in Ottawa, Canada (IDDM, Oct. 2).

The guidance covers sharing information when there is a serious health threat associated with a medical device, defined as any event that results in imminent risk of death, serious injury or serious illness that requires prompt medical action. It further defines a serious injury as:

• A life-threatening illness or injury;
• A permanent impairment of a body function or permanent damage to body structure; or
• A condition necessitating medical or surgical intervention to prevent permanent impairment of body function.

The NCAR 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).

A trend noticed by an NCA is circulated when the frequency of the event associated with the device is significantly higher than the frequency recorded in the devicemaker’s file or is significantly higher than the frequency observed with similar devices.

Examples of trends include the review of data from a national registry that indicates a potential concern regarding high revision rates such as hip prostheses for metal-on-metal implants. Other such trends could come from reviews of adverse event data and literature for a specific medical device.

An NCA may request or share information about a specific device or class of devices concerning:

• An event or events;
• An increased seriousness or frequency to what was previously reported;
• Major weaknesses and/or major deviations regarding a manufacturer’s quality management system; and
• Regulatory status changes of a device.

Participation in the NCAR program will be limited to IMDRF Management Committee regulators from Australia, Brazil, Canada, China, Europe, Japan, Russia and the U.S.

Regulators who want to participate in the program must have confidentiality arrangements in place with other participating NCAs and the NCAR Secretariat.

The guidance notes that “none of the information in the NCAR may be released without the explicit authorization of the authoring NCA.”

Read the NCAR guidance here: www.fdanews.com/10-24-17-IMDRFpostmarketguidance.pdf.