MDR Exemptions
Device type exemptions
Some device types are exempt from MDR requirements under 21 CFR Part 803 if FDA has determined that the reporting would not serve the public health objectives of MDR. These exemptions are published in FDA regulations and guidance.
Examples of historically exempt device types include some custom devices and devices used only in research.
Foreign events
Manufacturers are not required to submit MDRs to FDA for events that occur solely outside the United States — unless the device is legally marketed in the USA and the event involves the same device type and would be reportable if it occurred domestically.
Requesting an exemption or variance
Manufacturers may submit a written exemption or variance request to FDA under 21 CFR § 803.19 if standard MDR requirements are not appropriate for their specific situation. FDA may grant an alternative reporting mechanism.