Application of transitional provisions for certification of class D in vitro diagnostic medical devices according to Regulation (EU) 2017/746
From May 2022, the In Vitro Directive 98/79/EC will be repealed with the new In Vitro Medical Device Regulation (IVDR (EU) 2017/746). In accordance with this Regulation (EU) 2017/746, devices will change the classification rules and shall be classified into classes A, B, C and D, taking into account the intended purpose of the devices and their inherent risks (Article 47).
Guidance on Classification Rules for in vitro Diagnostic Medical Devices under Regulation (EU) 2017/746
The classification of a device is defined by its intended purpose, as specified by the manufacturer in the technical documentation of the device. Where there is a foreseeable risk that a device may be used for purposes which are covered by other classification rules and which would result in classification of a device into a higher class, a clear limitation of use should be included in the technical documentation (Labels, IFU…).