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21 December 2022

European Commission position paper on hybrid audits


The European Commission’s Medical Device Coordination Group (MDCG) published a definition on ‘hybrid audits’ in early December. The document (MDCG 2022-17, MDCG position paper on ‘hybrid audits’)  gives notified bodies some flexibility regarding the duration of physical presence during audits under the Medical Device Regulation (MDR) and the In Vitro Diagnostic Device Regulation (IVDR).


Due to the global COVID-19 pandemic, travel restrictions and other regulations resulted in the suspension of traditional on-site audits. Instead, information and communication technologies (ICTs) have made so-called ‘hybrid audits’ increasingly common. ICTs are explained in Guideline MDCG-2020-4 (Guidance on temporary extraordinary measures related to medical device Notified Body audits during COVID-19 quarantine orders and travel restrictions) and the accompanying Q&A (MDCG 2020-17, Questions and Answers related to MDCG 2020-4). 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).“


When establishing audits, notified bodies should allow adequate time to review relevant processes at the premises and clearly document which parts of the conformity assessment must be conducted at the premises and which can be conducted remotely. The MDCG can then decide, based on experience, whether changes are necessary. In addition, the MDCG has asked the Notified Body Coordination Group (NBCG-Med) to further elaborate on the operational elements that must be performed on the premises of the auditee.