The purpose of this guidance document is to clarify what products fall in scope of Regulation 2017/746 on in vitro diagnostic medical devices (IVDR) – also referred to as ‘qualification’ as an in vitro diagnostic medical device (IVD) or an accessory to an IVD. In order to be qualified as an IVD or an accessory to an IVD, the product must fulfil the definition in Art 2(2) or Art 2(4) of the IVDR respectively. The qualification depends on the intended purpose as described by the manufacturer.
The demarcation between the IVDR and Regulation (EU) 2017/745 on medical devices (MDR) is of particular importance because the MDR lays down in its article 1 that it shall not apply to in vitro diagnostic medical devices (IVDs)…
