European Commission: Position paper on 'hybrid audits'

In early December, the European Commission's MDCG (Medical Device Coordination Group) published a definition of 'hybrid audits'.

The record gives notified bodies some flexibility pertaining to the duration of physical presence during audits under the MDR (Medical Device Regulation) and the IVDR (In Vitro Diagnostic Device Regulation)

The 'hybrid audits' commonly increased due to the global COVID-19 pandemic. ICTs are defined in Guideline MDCG-2020-4 and the accompanying Questions & Answers.

The MDCG agrees on the definition hereunder to explain the meaning of the term 'hybrid audit':

"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 employing ICT (information and communication technologies)".

When establishing audits, notified organisations should allow adequate time to review appropriate processes at the premises. The MDCG would then decide, based on experience, whether modifications are necessary.

Further, the MDCG has asked the Notified Body Coordination Group (NBCG-Med) to additionally elaborate on the operational elements to be performed on the auditee's premises.