New position paper released by Team-NB related to ‘Notified bodies’ paper on the application of hybrid audits to quality management system assessments under MDR/IVDR’.

Hybrid audits in the context of legislative requirements

Notified bodies are required to undertake on-site audits of manufacturer’s QMS both as part of the initial audit and surveillance audits. In relation to the initial audit, Annex IX section 2.3 of Regulations (EU) 2017/745 (MDR)[1] and 2017/746 (IVDR)[2] states:

The assessment procedure shall include an audit on the manufacturer’s premises and, if appropriate, on the premises of the manufacturer’s suppliers and/or subcontractors to verify the manufacturing and other relevant processes.

In relation to surveillance audits, Annex IX section 3.3 of MDR/IVDR states:

Notified bodies shall periodically, at least once every 12 months, carry out appropriate audits and assessments to make sure that the manufacturer in question applies the approved quality management

system and the post-market surveillance plan. Those audits and assessments shall include audits on the premises of the manufacturer and, if appropriate, of the manufacturer’s suppliers and/or subcontractors.

In accordance with these requirements, where quality management system audits to MDR/IVDR are performed using alternative methods based on ICT, at least a portion of these audits must be performed on-site to cover the manufacturing and other relevant processes, i. e. the audit must be a hybrid audit defined as follows:

A ‘hybrid audit’ should be understood as an audit at the premises of the manufacturer or their supplier and/or subcontractor with at least one auditor present at the premises and other members of the audit team participating from elsewhere using information and communication technologies (ICT).

Such hybrid audits undertaken by appropriately qualified staff would satisfy the on-site audit requirements of MDR/IVDR referenced above.

From experience gained during pandemic, hybrid audits, when appropriately planned, are effective and have the following advantages compared to fully on-site audits:

• Hybrid audits may save up to 20‑25% of auditor capacities compared to on-site audits[1], allowing to redirect the capacity saved towards undertaking additional MDR/IVDR audits to aid in the overall MDR/IVDR transition from Directives
• More efficient use and increased availability of subject matter experts
• Increased audit effectiveness for certain activities (assessment of documentation)
• Less time and effort need spent on travelling and accommodation hence reducing travel constraints
• Reducing the risk of travel to high-risk areas (pollical unrest, pandemic etc.)
• Reducing the risk of burnout for auditors
• Recognising the grown acceptance of telework, hybrid audits are more sustainable and reduce the environmental impact of auditing