Part 1.1 of the MDR permits manufacturers, importers, and distributors to continue importing and selling COVID-19 medical devices authorized under IO No. 3. As an example:
Under these Regulations, all active authorizations under IO No. 3 are considered authorizations for importation and sale.
If the device is on the UPHN list, the manufacturer is not required to take any immediate action.
Manufacturers’ applications submitted under IO No. 3 for which we have yet to issue a decision are considered active applications under these Regulations.
Applications for amendments to authorized devices and new applications for authorization are examples of these.
The manufacturer is not required to take any immediate action.