Feature: Medical electronics
There are steps to consider when designing medical electronic devices [Credit to Umberto, Unsplash]
Recalls of medical electronics are rising and the sector must respond
By Pete Gillett, CEO, Marketpoint Recall M
edical electronic devices are caught in an almost constant cycle of recall. From diagnostic systems
to battery-powered monitoring equipment, safety notices land with regular frequency. While the overall objective of preventing
faults and improving performance is the right one, the impact of recalls is considerable. When a device is in use on a ward or in a patient’s home, the issue shiſts from design to response. Hospitals must trace affected units, isolate them and maintain care without disruption. At the same time, patient care can be at best disrupted and, in extreme cases, put at risk. On top of all of this, manufacturers must deal with the administrative and regulatory burden of swapping one product for another – oſten in many languages.
A system under strain It’s little wonder the current system is under strain. Recent reports confirmed that medical device recalls in the UK and EU have reached a ten-year high. In the UK alone, the Medicines and Healthcare products Regulatory Agency (MHRA) commissioned benefit risk evaluations for nearly 310 medical device failed
28 April 2026
www.electronicsworld.co.uk Failures occur
because components degrade, batteries overheat and
firmware behaves unpredictably in real- world conditions
safety notices in 2024 and 2025, reflecting sustained pressure across the system. Part of this trend are linked to the
progress itself: devices are smaller, smarter and more connected. AI-driven image analysis, remote monitoring platforms and portable diagnostics are now embedded in everyday care. At system level, healthcare is now truly global: A unit designed in Germany may be assembled in Asia, shipped through multiple distributors, and ends up in a clinic in Korea or a home in Holland. Keeping track of where every device sits at any moment is a monumental task. When units need identifying, isolating or replacing, that complexity multiplies. Failures occur because components degrade, batteries overheat and firmware
behaves unpredictably in real-world conditions. In healthcare, any uncertainty around safety is taken seriously. And rightly so – patient safety will always outweigh commercial hesitation. Tat culture of caution increases the likelihood that problems move quickly from observation to formal recall. On top of all this, regulations continue
to evolve. Te EU Medical Device Regulation has raised the bar for post- market surveillance and documentation. Manufacturers must monitor performance continuously and act quickly when risk emerges. What may once have been handled quietly as a service action is now more likely to trigger a formal failed safety notice. None of these pressures are temporary.
Tat is why the way medical electronics recalls are handled must improve. If the environment is not becoming simpler, the response can’t remain static.
Rethinking how recalls are handled Tere are clear ways the current system can improve, especially in medical electronics where traceability and documentation are critical:
Design for digital traceability Every device should be linked to batch
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