Medical Information Requests

Any unsolicited request from a Healthcare Professional (HCP) for medical, scientific, or technical information that gets routed to Medical Affairs (MA) because it cannot be answered based on the particular product’s current prescribing information, or Instructions for Use (IFU), as cleared or approved by the appropriate competent regulatory authority (e.g. Food and Drug Administration (FDA), or other local authority).

The MIR form must be signed and dated by the requesting HCP. Completion of the MIR Submission via this website is considered an electronic signature and consent from the submitter that the request is unsolicited and unprompted by a company representative.

If Medical Affairs personnel receive a request for medical information from an HCP indirectly via another Medical Devices (MD) representative outside of Medical Affairs, they may not respond, but should direct the employee to advise the HCP to use one of the approved MIR intake channels (such as this website or the links to the PDF Forms) to contact Medical Affairs personnel directly.
Responses to MIRs are prepared by Medical Affairs subject matter experts. Treatment recommendations are not permitted.

Any undesirable or potentially undesirable health consequence associated with the use of a product in or on a patient, whether or not considered product related (e.g., Adverse Events, Medical Device Reportable Events, Medical Device Vigilance, or medical occurrences).

A complaint is any written, electronic or oral communication that alleges deficiencies related to the identity, quality, durability, reliability, safety, effectiveness, or performance of a device after it is released for distribution. Distribution is defined as outside of Johnson & Johnson control.

Adverse Event Reporting: Remember to contact the local representative in case any adverse event or product quality complaint occurs while using our product and comply with your local regulations for notification​