P
Facts:
Medical device incident reported in the EU
Does the manufacturer need to file an MDR with the FDA if the device was reported in the EU?
patricia
Medical device incident reported in the EU
- incident did not meet the criteria for reportability (Death/serious injury/etc)
- Device is built by US company and distributed in the EU
Does the manufacturer need to file an MDR with the FDA if the device was reported in the EU?
- (there are no incidents associated with this device in the U.S., now or in the lifetime of the device)
- I have searched 21 CFR 803, and there is no mention of this scenario - only from the aspect of foreign distributor to U.S.
- Again - the incident does not meet the criteria for reportability, but was reported in the EU by another entity.
- Our notified body was made aware by us that there was an event reported, but it did not meet the reporting requirements in the EU either.
patricia