MDCG 2022-17 : MDCG position paper on ‘hybrid audits’– December 2022

This MDCG document clarifies the definitions and conduct of the so-called “hybrid” audits used in the MDR and the IVDR. The definition of a hybrid audit is established and defined as follows: audit performed at the manufacturer’s premises or its supplier(s) and/or subcontractor(s), with at least one auditor present at the premises and other members of the audit team participating from another location using information and communication technologies (ICT).