The Medical Device Coordination Group released a new position paper on ‘hybrid audits’: MDCG 2022-17
The document is short and to the point, defining hybrid audits and how they can be used under the MDR and IVDR.
MDCG 2022-17 confirms that the conformity assessment procedure must include an audit of the manufacturer’s premises for the initial assessment and for periodic surveillance. This same requirement applies to the manufacturer’s suppliers and/or subcontractors.
‘Hybrid audits’ are defined 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 onsite portion can be from the opening meeting until the closing meeting, or for a portion of that time.
It is up to the Notified Body to ensure they plan sufficient time to audit relevant processes on the auditee’s premises, and to document which parts of the conformity assessment process may be carried out on the premises versus via information and communication technologies.