PART IVIn Vitro Diagnostic Medical Devices
CE marking ofin vitro diagnostic medical devices that come within the scope of more than one Directive37.
Where a relevant device comes within the scope of Directive 98/79 and another Directive (“the other Directive”) issued by one or more of the institutions of the Community, no person shall affix a CE marking to the device unless the relevant requirements of the other Directive are satisfied, except where—
(a)
the other Directive includes a provision allowing the manufacturer of the device to choose, during a transitional period that has not ended, which set of arrangements applies to it;
(b)
the manufacturer chooses to follow the set of arrangements in Directive 98/79;
(c)
the marking of the device indicates that the device only satisfies the set of arrangements chosen by the manufacturer; and
(d)
the particulars of Directive 98/79, as published in the Official Journal of the F1European Union, are given in the documents, notices or instructions accompanying the device.