Day

May 15, 2021
15
May

EC Draft Regulation for Electronic IFU

May 15, 2021
The European Commission (EC) has released a draft regulation that expands the device categories authorized to provide instructions for use in electronic form instead of paper instructions to include certain medical devices including SaMD.  Articles 3 and 5 describe the eligible devices and conditions where this is the case, while Articles 6 and 7 detail...
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