This guidance, relating to the application of Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) addresses the classification of in vitro diagnostic medical devices (IVDs) and provides clarifications on the classification rules as set out under Annex VIII. This classification guidance also applies to diagnostic or information society services performed on EU patients or devices put in to service through distance sales.
The guidance has been developed by an expert group representing Member State Competent Authorities, Commission services, notified bodies and industry. This guidance also takes into account the Corrigendum published in the Official Journal of the European Union on 27 December 2019. As this document is intended to provide useful information to ensure the uniform application of the relevant Regulatory provisions, it should always be read in conjunction with the IVDR.
The primary purpose of this document is to provide guidance to manufacturers, notified bodies and health institutions on how to classify an IVD prior to placing it on the market, making available on the market or putting into service in the Union. It is also intended to inform regulators and other stakeholders when assessing the class attributed to an IVD by a manufacturer or a health institution.
It is important to recall that the IVDR sets out a legal empowerment for the classification of IVDs. Therefore, and only at the request of a Member State, or on its own initiative, the Commission shall after consulting the Medical Device Coordination Group (MDCG), decide by means of implementing acts, on the application of Annex VIII to a given device, or category or group of devices, with a view to determining the classification of such devices (Article 47 (3-4) of the IVDR). To the extent necessary to resolve issues of divergent interpretation and of practical application, the Commission may adopt implementing acts, in order to ensure the uniform application of the classification rules, taking into account the relevant scientific opinions of the relevant scientific committees (Article 47 (5) of the IVDR).
Examples in this document are provided for illustrative purposes only and do not represent an exhaustive list.
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