NBCG-MED Publishes Operational Elements for Hybrid Audits under MDR and IVDR
The Notified Bodies Coordination Group (NBCG-MED) has published NBCG-MED 2024-1, titled “Application of hybrid audits to quality management system assessments under MDR/IVDR – operational elements”.
The document, dated June 2024, reflects the consensus position of notified bodies designated under the Medical Device Regulation (EU) 2017/745 and the In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746.
According to the document, it was initially developed and adopted by notified bodies as a Team-NB position paper and later updated following comments from the MDCG Notified Body Oversight subgroup.
Background
NBCG-MED explains that quality management system audits have traditionally been performed on-site.
During the global pandemic, notified bodies implemented alternative methods using information and communication technologies (ICT), in line with applicable requirements and guidance such as MDCG 2020-4 and IAF MD 4.
The document was developed following advice from the MDCG to further elaborate operational elements of hybrid audits, including which aspects should be audited on the auditee’s premises.
Hybrid Audits under MDR and IVDR
The document recalls that notified bodies are required to carry out on-site audits of the manufacturer’s QMS as part of both initial audits and surveillance audits.
A hybrid audit is described as an audit on the premises of the manufacturer, supplier or subcontractor, with at least one auditor physically present and other audit team members participating remotely through ICT.
NBCG-MED states that such hybrid audits, when performed by appropriately qualified staff, satisfy the on-site audit requirements of the MDR and IVDR.
Audit Requirements
NBCG-MED identifies areas that may be effectively audited using ICT and areas that should be included in the on-site part of a hybrid audit.
Examples of activities that may be audited using ICT include:
QMS coverage and management responsibility;
regulatory compliance strategy;
risk management;
clinical evaluation;
post-market surveillance processes;
corrective and preventive actions;
supplier file review;
certain design and development activities.
The on-site portion should include, where relevant:
verification of the existence of the facility;
design transfer to production where on-site testing facilities are involved;
production and process controls;
work environment, infrastructure and warehouse or storage facilities;
equipment calibration and servicing;
in-process and final inspection;
incoming inspection or verification of purchased products.
Audit Team Qualification and Planning
The document states that the audit team must meet the qualification criteria specified in Annex VII of the MDR and IVDR.
The auditor performing the on-site part should be qualified for the relevant MDT or IVT codes appropriate to the processes physically occurring at the audited facility.
NBCG-MED also states that notified bodies must consider the manufacturer’s capability and suitability to support hybrid audits, including IT systems and whether QMS documentation and records are paper-based or electronic.
According to the document, at least 25% of the overall hybrid audit duration must be allocated to the on-site portion of the audit, although this may be reduced in duly justified cases.
Impact on Medical Device and IVD Manufacturers
For medical device and IVD manufacturers, the NBCG-MED position provides important clarification on how hybrid QMS audits may be applied under the MDR and IVDR.
Manufacturers should pay particular attention to:
readiness to support ICT-based audit activities;
availability of electronic QMS documentation and records;
identification of processes that require on-site verification;
production, inspection, storage and calibration activities;
supplier and subcontractor audit planning;
evidence of product compliance;
IT infrastructure and secure access to records;
coordination with notified bodies before the audit.
For manufacturers, hybrid audits may offer greater flexibility and reduce travel constraints, but they still require strong preparation for both remote and on-site audit components. Manufacturers should ensure that relevant records, personnel, facilities and processes are available in a format that supports efficient audit execution.
