Preparing for Adverse Events in Medical Laboratories According to IVDR

Prof. Dr. Diler Aslan

Medical laboratories play a vital role in accurate diagnostics and safe treatment pathways. However, adverse events such as equipment malfunctions, false results, or labeling errors can pose serious risks to patient safety, institutional reputation, and legal compliance.

With the implementation of the EU In Vitro Diagnostic Medical Devices Regulation (IVDR), laboratories are now more directly accountable in the vigilance and incident reporting process. Being unprepared is no longer an option.

What Is an Adverse Event Under IVDR?

According to Article 82 of the IVDR, an adverse event—termed a “serious incident”—refers to any incident involving a device that leads to:

• Death or serious deterioration of a patient’s health
• A public health threat
• The necessity of a field safety corrective action (FSCA)

Even manufacturers’ voluntary recalls due to performance issues must be tracked and notified appropriately.

Who Must Report? Not Just Manufacturers

While manufacturers are the primary party responsible for reporting incidents to national competent authorities, laboratories as device users also play a key role:

• They may initiate investigations or support root cause analysis.
• They are often the first to detect anomalies in device behavior or unexpected test results.
• Their collaboration is crucial in documenting and containing potential risks.

Reporting Deadlines Under IVDR

Incident Type	Reporting Deadline
Public health threat	Within 2 days
Death or serious deterioration	Within 10 days
Other serious incidents	Within 15 days

Laboratories must ensure their procedures align with these deadlines—even if the actual report is submitted by the manufacturer.

How Should a Laboratory Prepare?

To meet IVDR obligations and maintain patient safety, laboratories should:

• Establish an internal incident documentation process
• Record device details (e.g. model, lot/serial numbers) and testing context
• Preserve the device for investigation when feasible
• Develop an incident escalation plan involving quality officers
• Collaborate with manufacturers to provide usage logs and observations

Trend Reporting: What About Non-Serious Issues?

Even events not classified as serious incidents may still require “trend reporting” under Article 83 of the IVDR. If laboratories detect a statistically significant increase in:

• False positives or false negatives
• Unexpected side effects
• Instrument instability

…they must work with manufacturers to ensure reporting compliance.

How Consulting Can Help You Stay Ahead

My consulting services support both public and private laboratories in:

• Building IVDR-compliant incident workflows
• Drafting standard operating procedures (SOPs) for adverse events
• Conducting staff training and awareness workshops
• Assisting in communication with competent authorities and manufacturers
• Implementing a vigilance documentation system that satisfies ISO 15189 and IVDR together

Don’t Wait for the First Incident

Being prepared before an adverse event happens is the smartest and most responsible path forward. I can help you design a system that’s both compliant and practical—ensuring your laboratory operates safely, confidently, and in full alignment with IVDR.

👉 Ready to prepare your lab for IVDR-compliant vigilance? Get in touch today.