new
as defined in Regulation (EU) 2017/746 of the European Parliament and of the Council of…
2.13.
indication as to whether the device is a ‘new’ device.
A device shall be considered to be ‘new’ if:
(a)
there has been no such device continuously available on the Union market during the previous three years for the relevant analyte or other parameter;
(b)
the procedure involves analytical technology not continuously used in connection with a given analyte or other parameter on the Union market during the previous three years.