Theme Hybrid audits
Target Audience Notified bodies, Manufacturers
Products concerned MD/IVD
Regulatory reference MDR (EU) 2017/745
IVDR (EU) 2017/746
Documents mentioned

MDCG 2020-4

MDCG 2020-17

MDCG 2022-14


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).