MDCG Position on Hybrid Audits

The EU’s Medical Device Coordination Group (MDCG) have outlined their opinion on the practice of hybrid audits by Notified Bodies in their position paper MDCG 2022-17.

Hybrid audits, in which Notified Bodies would assess part of a manufacturer’s compliance over an online conference call, became popular during the COVID-19 pandemic which limited travel as well as put restrictions on face to face meetings in some countries. However, certain conformity assessment procedures require the auditor to actually be on site to assess a manufacturer’s Quality Management System (QMS).

The MDCG settled on the following definition of a 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).

MDCG 2022-17

The Notified Bodies are expected to plan sufficient time to audit the relevant processes on the auditee’s premises. The audit plan shall clearly identified which conformity assessment procedures shall be carried out on site or using ICT.