Guidance on Classification Rules for in vitro Diagnostic Medical Devices under Regulation (EU) 2017/
Updated: Sep 24, 2022
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.
In accordance with Regulation (EU) 2017/746, devices shall be classified into classes A, B, C and D, taking into account the intended purpose of the devices and their inherent risks (Article 47). Robust risk-based classification rules are essential for the correct classification of devices according to Annex VIII as certain requirements set out by the IVDR are directly linked to device classification. In particular, the conformity assessment route is highly dependent on classification, which is reflected in concepts such as conformity assessments scrutiny of class D devices (Article 50), the involvement of European Union reference laboratories for high-risk devices (Article 100) and a consultation with a national medicines agency or the European Medicines Agency (EMA) for companion diagnostics (Article 48(3)). Many post-market requirements are also class dependent, e.g. annual surveillance assessments for class C and D devices, or the requirement to prepare a postmarket surveillance report or Periodic Safety Update Report (PSUR) for a given device (Articles 80 and 81).