Filing MDRs (Medical Device Report) for OUS (Outside United States) events

#1
If I am a US manufacturer of a product with both 510k clearance and CE Mark and I have a reportable event take place OUS, do I also need to file an MDR?

The latest MDR draft guidance says:
4.11.3 I?m a foreign manufacturer of a device that has been cleared or approved in the US and is also lawfully marketed in a foreign country. If an adverse event occurs in a foreign country with the device, must the event in the foreign country be reported under the MDR regulation?

Yes, FDA considers an event that occurs in a foreign country reportable under the MDR regulation if it involves a device that has been cleared or approved in the US ? or a device similar to a device marketed by the manufacturer that has been cleared or approved in the US ? and is also lawfully marketed in a foreign country. Devices may be manufactured to slightly modified specifications to meet standards in different countries. If these changes do not substantially alter the performance of the device, then any adverse events that are MDR reportable events relating to such modified devices should be reported under the MDR regulation (see section 2.14 of this guidance).
Their choice of text -- that it says foreign manufacturer -- appears deliberate, as several adjacent examples form the guidance say US manufacturer....though it's not clear to me why that would matter.

Anyone have recent experience with this?
 
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#2
If I am a US manufacturer of a product with both 510k clearance and CE Mark and I have a reportable event take place OUS, do I also need to file an MDR?

The latest MDR draft guidance says:

Their choice of text -- that it says foreign manufacturer -- appears deliberate, as several adjacent examples form the guidance say US manufacturer....though it's not clear to me why that would matter.

Anyone have recent experience with this?
maxximase, Welcome to the cove!

while I haven't had recent experience with MDRs, 21CFR803 definitions states:
"Manufacturer means any person who manufactures, prepares, propagates, compounds, assembles, or processes a device by chemical, physical, biological, or other procedure. The term includes any person who either:
(1) Repackages or otherwise changes the container, wrapper, or labeling of a device in furtherance of the distribution of the device from the original place of manufacture;
(2) Initiates specifications for devices that are manufactured by a second party for subsequent distribution by the person initiating the specifications;
(3) Manufactures components or accessories that are devices that are ready to be used and are intended to be commercially distributed and intended to be used as is, or are processed by a licensed practitioner or other qualified person to meet the needs of a particular patient; or
(4) Is the U.S. agent of a foreign manufacturer?"

That pretty much states that if you manufacture a medical device, and you become aware of a reportable event, then you have 30 days to make the report to the FDA.
 
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