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 placingit 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.