MDR (Medical Device Reporting) Liability Extension
What this clause says
Vendor shall maintain product liability coverage that extends to defense costs and indemnity for claims arising from FDA Medical Device Reporting (MDR) events, including MAUDE database reports, FDA Form 3500A reports, and post-market surveillance actions arising from Vendor's medical devices.
What this means in plain English
A products liability extension covering MDR-related defense and indemnity. MDRs (mandatory reports of device-associated death, serious injury, or malfunction) often precede or accompany product liability litigation; this extension ensures the products policy responds to defense costs at the MDR stage.
What it means for a CDMO program
Medical device manufacturers carrying products liability without explicit MDR extension may find coverage disputes when MAUDE reports trigger investigations. Most modern medical device products forms include MDR extension; verify the specific wording at policy review.
How this evaluates
The Decoder applies these rules in order; the first match wins.
- mdr › extension in place is set → Compliant: MDR liability extension in place.
- mdr › extension in place is not set → Borderline: No MDR extension indicated.
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Pre-loaded with this clause selected.
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