Update to MDCG Guidance on Classification Rules for in vitro Diagnostic Medical Devices under in vitro diagnostics Regulation

An update to the MDCG Guidance on Classification Rules for in vitro Diagnostic Medical Devices under the in vitro diagnostics Regulation has been published. The revision results from scientific advice issued by the European Medicines Agency's IVD expert panel in late January 2025 concerning the classification of devices to detect SARS-CoV-2. These devices were previously classified as Class D under Rule 1, 2nd indent (devices intended to be used for the detection of the presence of, or exposure to, a transmissible agent that causes a life-threatening disease with a high or suspected high risk of propagation). The tests are now classified as Class B under Rule 6 (devices not covered by Rules 1-5) when not intended for self-testing. The revision to the Guidance also confirms that most devices intended for self-testing fall within Class C, listing self-testing devices intended for the detection of SARS CoV-2 or antibodies against SARS CoV-2 as examples under Rule 4(a).