Unannounced Audits Under MDR: Are You Prepared?

Under the EU Medical Device Regulation, Notified Bodies are required to conduct unannounced audits of manufacturers and, where applicable, their suppliers and subcontractors. These audits are designed to verify that day-to-day operations consistently reflect the approved quality management system and technical documentation.

What Triggers an Unannounced Audit?

Unannounced audits may be conducted:

As part of routine surveillance

Following a vigilance report or field safety corrective action

Based on complaints or post-market surveillance signals

Randomly, as required by Notified Body procedures

What to Expect

During an unannounced audit, the Notified Body may:

Arrive without prior notice (though some may provide short notice as permitted)

Review production records, batch records, and quality records

Observe manufacturing and testing activities

Interview personnel

Verify that the QMS is implemented as documented

Assess whether technical documentation remains current and accurate

Common Findings

Frequent findings during unannounced audits include:

Discrepancies between documented procedures and actual practice

Incomplete or missing production records

Unapproved changes to processes, materials, or suppliers

Inadequate training records

Failure to maintain technical documentation in accordance with current requirements

Missing or outdated risk management documentation

Preparing for Unannounced Audits

Preparation is not about creating special conditions for the audit, it is about ensuring that your quality management system is consistently implemented every day. Key steps include:

Maintain Audit-Ready Records: Production, quality, and training records should be complete, accurate, and accessible at all times.

Conduct Internal Readiness Assessments: Periodic self-assessments can identify gaps before they are found during an unannounced audit.

Train Personnel: Employees should understand their roles and be prepared to interact professionally with auditors.

Keep Technical Documentation Current: Ensure that your technical file reflects the current device, processes, and applicable standards.

Manage Changes Systematically: Any change to processes, suppliers, or materials should be assessed for regulatory impact and documented appropriately.

How We Help

Veritas Quality Solutions conducts on-site audit readiness assessments across Pakistan, KSA, UAE, and Turkey. Our audits simulate the approach used by Notified Bodies, helping you identify and resolve gaps before they become findings.