A medical information request (MIR) is an unsolicited question from a healthcare professional that a company’s Medical Affairs team must answer because the product’s approved labeling doesn’t cover it. MIRs arrive by phone, email, web form, or field reps, and range from dosing and drug interactions to device use, off-label questions, and safety.
What is a medical information request?
In life sciences, a medical information request is a question about a drug, biologic, or device that goes beyond what the approved prescribing information or instructions for use (IFU) already answer. Because the answer isn’t in the label, it can’t come from a sales rep or standard marketing material — it has to be handled by a qualified Medical Information or Medical Affairs function.
Two details make MIRs distinct. First, they’re usually unsolicited: the healthcare professional (HCP) asks on their own initiative, rather than being prompted by the company. Second, they’re scientific or technical, not commercial. “Can this be used in patients with renal impairment?” is a MIR. “What’s the wholesale price?” is not.
What kinds of questions count as MIRs?
MIRs span the clinical and technical topics an HCP might raise. Common categories include:
- Dosing and administration — adjustments for age, weight, or renal and hepatic function.
- Drug interactions — how a product behaves alongside other therapies.
- Off-label or off-instruction use — questions about uses that aren’t in the approved label.
- Safety and adverse events — side effects, contraindications, or a report of something that happened to a patient.
- Device indications and technique — correct use, compatibility, or troubleshooting for a device.
- Clinical and trial data — study results, mechanism of action, or the evidence behind a claim.
Some of these overlap with other regulated processes. A MIR that describes a patient reaction, for example, may also trigger an adverse event report — one reason capturing the full inquiry accurately matters so much.
Why medical information requests matter
A MIR is often the only scientific conversation a company has with a prescriber. Handle it well and you reinforce trust in the product and the medical team behind it. Handle it poorly — a slow reply, an inconsistent answer, an off-label question fielded by the wrong person — and you create both a clinical risk and a compliance one.
There’s also a documentation dimension. Regulators expect a defensible record of what was asked, what was answered, and on what evidence. When that history lives in scattered inboxes and spreadsheets, reconstructing it for an audit is slow and error-prone. A structured MIR process turns each inquiry into a traceable record instead of a loose email thread.
The medical information request process
Most compliant MIR workflows follow the same lifecycle, whatever the therapeutic area:
- Intake. Capture the inquiry and its context — who asked, through which channel, about which product — without losing detail.
- Triage and routing. Categorize the request, set a priority, and route it to the right person or team.
- Research and response. Build an accurate, balanced, evidence-based answer from approved sources, with subject-matter input where needed.
- Fulfillment. Deliver the response to the HCP promptly and in their preferred format.
- Documentation and audit. Log the full interaction so it can be reviewed, reported, and defended later.
The exact steps vary by company, but the principle holds: every inquiry should be captured, owned, answered from approved information, and recorded.
Compliance considerations for MIRs
Medical information sits close to some of the most scrutinized rules in life sciences, so a few points are worth understanding.
Unsolicited vs. solicited. This distinction is central to off-label communication. FDA guidance allows companies to respond to unsolicited requests for off-label information through medical, non-promotional channels, provided the response is accurate, balanced, and non-promotional. That is exactly the lane a well-run MIR process operates in.
Separation from promotion. Industry codes such as the PhRMA Code on Interactions with Health Care Professionals reinforce keeping scientific exchange separate from commercial messaging. MIRs belong with Medical Affairs, not sales.
Audit trail. Because inquiries can touch safety and off-label topics, a complete, time-stamped record of each interaction is essential for internal QA and regulatory review.
How medical information software helps
Small teams can run MIRs on email and a spreadsheet — until volume, multiple channels, and audit demands make that fragile. Purpose-built medical information software (sometimes called an information request management system, or IRMS) brings every channel into one queue, applies consistent categories and priorities, and logs every action automatically.
MedInfosys, for example, captures HCP inquiries from web forms, email, phone, and an authenticated portal into a single case record, gives agents an approved-content knowledge base to answer from, and keeps a complete audit trail on every ticket — the kind of traceability a compliance review depends on.
Frequently asked questions
What does MIR stand for?
MIR stands for medical information request: an unsolicited question from a healthcare professional about a drug, biologic, or device that a company’s Medical Affairs or Medical Information team answers.
Who handles medical information requests?
MIRs are handled by a company’s Medical Information or Medical Affairs function, not by sales or marketing, because the answers are scientific and often fall outside approved promotional material.
Is a medical information request the same as an adverse event report?
No. A MIR is a question, while an adverse event report documents a suspected harm. They are separate processes, but a single MIR can surface an adverse event, so intake needs to flag and route safety information appropriately.
Can a company answer off-label medical information requests?
Yes, within limits. FDA guidance permits companies to respond to unsolicited off-label requests through non-promotional medical channels, as long as the response is accurate, balanced, and evidence-based.
How are medical information requests tracked?
Larger teams track MIRs in a medical information platform or information request management system that logs each inquiry, its category and priority, the response sent, and a full audit trail for compliance.
What is the difference between a MIR and a product complaint?
A MIR asks for information; a product complaint reports a problem with the product itself. Both require documentation, but they follow different workflows and often different regulatory obligations.
Bring every medical inquiry into one place
Understanding what a MIR is comes first; handling MIRs consistently at scale is the harder part. See how MedInfosys unifies HCP inquiries across every channel into one compliant, auditable workflow — or request a demo to see it with your own products.
