In September 2022, Team-NB published a position paper on hybrid audits for quality management system assessments of medical devices under MDR/IVDR. Team-NB is the European Association for Medical devices of Notified Bodies. This document aims to express the association’s view and suggestions on a potential guidance document on hybrid audits.
Hybrid audit: context and definitions
Usually, audits are conducted on-site. However, during the pandemic notified bodies implemented new ways to conduct audits using ICT (Information and Communication Technology). As the medical devices Regulations (MDR and IVDR) state, 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. Notified Bodies shall conduct an audit at least once a year. This ensures that the manufacturer applies the approved quality management system and post-market surveillance plan (surveillance audit).
When Notified Bodies perform an audit using ICT, they should at least conduct one part of the audit on-site. Specifically, the definition of a hybrid audit is the following:
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).
Requirements for an effective and advantageous hybrid audit
In their position paper, Team-NB states that, among others, hybrid audits:
- can save up to 20 25% of auditor capacities
- increase the availability of experts and audit effectiveness for certain activities
- reduce the risk of burnout for auditors and risk related to travel to high-risk areas
- are more sustainable
However, their position also expresses the necessity to perform certain inspections on sites, such as:
- infrastructure and work environment
- production and incoming/in-process/final inspection and servicing
- design transfer to manufacture and warehouse/storage facilities
On the other hand, the activities to audit online effectively are
- management and improvement
- human resources and purchasing
- design, development, traceability
Qualification, planning and duration
When auditors perform hybrid audits, on-site auditors should be qualified for the MDT/IVT codes necessary to perform the physical part of the audit. Nonetheless, other auditors can assist with the assessment in case it is not possible that the on-site auditor has all qualifications required.
The duration of the audit foresees:
- 20% to 30% for the production and service controls subsystem
- at least 25% for the on-site portion of the audit
Eventually, the position paper specifies that auditors can perform the full audit remotely if there is no location to visit. Nevertheless, this must imply that there is no physical handling of the product.
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