MDCG Position Paper on Hybrid Audits

Implemented during the pandemic and helped by new technologies, hybrid audits have become more frequent. A hybrid audit is an audit conducted on site and remotely.

MDCG definition of Hybrid Audit

In December 2022, the Medical Device Coordination Group (MDCG) published a position paper on hybrid audits. Firstly, the Group provides a definition of “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 using information and communication technologies (ICT).

Secondly, the position paper highlights the following points:

• The auditor is present either from the beginning to the end of the assessment activity or for a portion of that time.
• The auditor can carry out a conformity assessment activity from a) elsewhere or b) simultaneously on the site and elsewhere.
• Notified bodies need to plan sufficient time to carry out the conformity assessment. In addition, they should clearly identify the parts of the assessment they will perform remotely, using information and communication technologies (ICT).

NB position paper on hybrid audits

In September 2022, Team-NB published a position paper on hybrid audits for quality management system assessments of medical devices. Among others, the NB paper presents definition, requirements, context, and qualification for a proper assessment through a hybrid audit.

Check out our recent article on the position paper on hybrid audits published by Team NB. Team NB is the European Association for Medical devices of Notified Bodies.