This paper outlines the Medical Device Coordination Group (MDCG) position on the possible use of hybrid audits by notified bodies under Regulation (EU) 2017/745 on medical devices (MDR) and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR).
It is recognised that there was a disruption to the traditional auditing method during the global COVID-19 pandemic due to travel restrictions and other health advice at that time. Since then, auditors and auditees have become accustomed with the use of information and communication technologies (ICT) during audits as described in MDCG 2020-4 and MDCG 2020-17
This paper aims to provide a definition for hybrid audits and clarifications with respect to how hybrid audits can be used under MDR and IVDR as advised following the publication of MDCG 2022-14.
Certain conformity assessment procedures under the MDR and the IVDR require the notified body to carry out audits of the manufacturer’s quality management system (QMS). The assessment procedure must include an audit on the manufacturer’s
premises both for the initial assessment4 and for the periodic surveillance
The same requirement applies, as appropriate, for audits to occur on the premises of the manufacturer’s suppliers and/or subcontractors.
In addition to the terms ‘premises’ or ‘on the premises’, also ‘on-site’ and ‘off-site’ are used in the MDR and the IVDR to describe where conformity assessment activities take place.