What happens if a medical device fails? Explaining recalls, adverse event reporting, and how authorities protect patients in the EU

Medical devices are designed to improve health and quality of life, but what happens if a device fails? In the European Union strict regulations exist to protect patients and ensure that faulty medical devices are addressed promptly. From reporting adverse events to initiating recalls, multiple mechanisms are in place to minimize risks and maintain public safety.

What is a medical device failure?

A medical device failure occurs when a product does not perform as intended, potentially leading to risks for patients or users. This can include malfunctions, defects, or issues related to software errors, material degradation, or improper labeling. Failures may result in minor inconveniences, but in serious cases, they can lead to health complications, injuries, or even fatalities.

The EU Medical Device Regulation (MDR 2017/745) and the In Vitro Diagnostic Regulation (IVDR 2017/746) establish rules for how manufacturers, healthcare professionals, and regulators must respond to such incidents.

How are medical device failures reported?

To ensure patient safety, medical device failures must be reported to the relevant authorities. This process is known as adverse event reporting or vigilance reporting, and it involves multiple stakeholders, including:

• Manufacturers – Must report incidents to the Competent Authorities (national regulators) and conduct investigations.
• Healthcare Professionals – Doctors, nurses, and medical staff are required to report device failures they observe in clinical settings.
• Patients and Users – In some cases, individuals can directly report issues through national health agencies or online platforms.

Reports are typically submitted through the EUDAMED database, a centralized European system that tracks adverse events and helps regulators monitor device safety. The goal is to identify patterns and prevent widespread issues before they cause harm.

What happens after a device failure is reported?

Once an adverse event is reported, regulatory authorities and manufacturers investigate the issue. This process includes:

• Risk Assessment – Determining the severity of the failure, its potential consequences, and whether similar incidents have occurred.
• Corrective Actions – Manufacturers may update labeling, issue warnings, or modify device designs.
• Regulatory Oversight – Competent Authorities evaluate whether additional measures, such as restrictions or recalls, are necessary.

If a device poses an immediate risk, it may be subject to field safety corrective actions (FSCAs), which can include product modifications, software updates, or replacements.

Medical device recalls in the EU

A recall is the most serious response to a medical device failure. When a device is deemed unsafe, it must be withdrawn from the market to protect patients. Recalls are classified into different levels based on risk:

• Field Safety Notice (FSN) – A notification issued by the manufacturer to inform users of a potential risk and provide instructions.
• Voluntary Recall – Initiated by the manufacturer when a defect is discovered.
• Regulatory Recall – Ordered by national Competent Authorities when a device poses a significant risk and the manufacturer has not acted sufficiently.

In all cases, manufacturers are responsible for ensuring that recalled devices are removed from use and, where applicable, replaced or repaired. Authorities monitor the process to verify compliance and prevent further harm.

How the EU protects patients

The EU has strict regulatory measures to prevent and address medical device failures:

• Notified Bodies – Independent organizations that assess devices before they reach the market, ensuring compliance with safety standards.
• Post-Market Surveillance – Continuous monitoring of medical devices after approval to detect emerging risks.
• EUDAMED Database – A centralized system for tracking adverse events, device registrations, and recalls.
• Competent Authorities – National regulators that enforce corrective actions and ensure compliance with EU laws.

These safeguards help maintain public confidence in medical devices and ensure that failures are swiftly addressed.

Medical device failures are taken seriously in the EU, with structured systems in place for reporting, investigation, and corrective action. Through vigilance reporting, recalls, and regulatory oversight, patients are protected from potentially harmful products. While no system can entirely prevent device failures, the EU’s rigorous approach ensures that risks are managed swiftly and effectively to maintain public safety.