Introduction
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).
The present guidance document provides non-exhaustive lists of examples of IVDs and accessories to IVDs. Further detailed examples may be found in the Manual on Borderline and Classification in the Community Regulatory framework for medical devices. The reader could also find it useful to consult MDCG 2019-11 “Guidance on Qualification and Classification of Software in Regulation (EU) 2017/745 – MDR and Regulation (EU) 2017/746 – IVDR”. Both documents are published on the European Commission website.
The examples provided are indicative and the qualification of specific products should be considered on a case-by-case basis by each manufacturer based on their intended purpose. Thus, products detecting or measuring the same analyte could be qualified differently, depending on the intended purposes as assigned by each manufacturer.
MDCG 2024-11 - Guidance on qualification of in vitro diagnostic medical devices (October 2024)
MDCG 2024-11 - Guidance on qualification of in vitro diagnostic medical devices (October 2024)
health.ec.europa.eu
