12.12.2022
To the attention of manufacturers of medical devices, in vitro diagnostic medical devices and all stakeholders
Please be informed that on 6 December 2022, the European Commission published the MDCG 2022-17 Guidance: MDCG (Medical Device Coordination Group) position paper on ‘hybrid audits’.
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).
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 2022-143. 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 assessment 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.
To clarify the meaning of the term ‘hybrid audit’, the MDCG agrees on the following definition.
A ‘hybrid audit’ should be understood as an audit on the premises of the manufacturer or its supplier(s) and/or subcontractor(s) with at least one auditor present on the premises and other members of the audit team participating from elsewhere using information and communication technologies (ICT).
The announcement of the European Commission is available online at: https://health.ec.europa.eu/latest-updates/mdcg-2022-17-mdcg-position-paper-hybrid-audits-december-2022-2022-12-06_en
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