Guidance published on classification rules for IVD medical devices

Article summary

The European Commission has published the guidance on classification rules for in vitro diagnostic medical devices (IVD) under Regulation (EU) 2017/746 (the In Vitro Diagnostic Medical Devices Regulation). The guidance identifies the classification of IVDs and gives clarifications on the classification rules outlined under Annex VIII. The guidance also applies to diagnostic or data society services carried out on EU patients or devices placed in to service through distance sales. The guidance aims to provide manufacturers, notified bodies and health institutions on the best way to classify an IVD before placing it on the market, making it accessible on the market or putting it into service in the EU. In addition, the guidance informs regulators and other stakeholders when evaluating the class attributed to an IVD by a manufacturer or a health establishment.