From Development to Patient: Ensuring the Safety of Medical Devices

Ensuring and verifying the safety of medical devices is essential for their safe use and for protecting patients.

The final product must operate safely and reliably under all intended conditions of use, whether it is a simple medical device or a complex piece of equipment. Medical device safety must be addressed and managed throughout the entire product life cycle – from design and development to testing, manufacturing and use. Manufacturers must therefore take numerous technical, clinical and regulatory requirements into account from the earliest stages of development.

As an independent testing and certification body and a notified body for medical devices, SIQ provides manufacturers with a broad range of medical device assessment and testing services. These range from conformity assessment under Regulation (EU) 2017/745 (MDR) to electrical safety testing, electromagnetic compatibility (EMC) testing, cybersecurity testing, and training on the interpretation of applicable standards and regulatory requirements. By bringing expertise and testing capabilities together in one place, SIQ can support manufacturers in assessing various aspects of product safety throughout the entire product life cycle.

Electricity – a risk we rarely think about

One of the key elements in medical device verification is electrical safety testing. Electrical and electronic medical devices are verified to determine whether they are designed so that, when used as intended, they do not pose unacceptable risks to patients or users. This includes assessing protection against electric shock, the adequacy of insulation, and hazards associated with overheating, fire and mechanical effects.

Particular attention is also paid to parts of the device that come into direct contact with the patient, as these must provide an appropriate level of protection even in the event of a single fault. Testing therefore confirms that the protective measures are effective not only during normal operation but also under reasonably foreseeable adverse conditions.

Experts involved in the assessment process

The European Medical Device Regulation (MDR) sets out the requirements manufacturers must meet before placing their medical devices on the European Union market. For each device, manufacturers must demonstrate compliance with the general safety and performance requirements. This means identifying and evaluating risks, demonstrating the safety and performance of the device under its intended conditions of use, and preparing comprehensive technical documentation.

Due to its complexity, the conformity assessment process can be lengthy and may take more than a year and a half, as the notified body must thoroughly assess compliance with the requirements relating to the safety and performance of the device.

In addition to reviewing the technical documentation, an important part of the process is the assessment of the clinical evaluation, through which the manufacturer uses appropriate clinical evidence to demonstrate that the device is safe and clinically effective for its intended purpose. Depending on the type of device, the assessment process involves experts from a range of disciplines, including sterilisation, biocompatibility, electrical safety and electromagnetic compatibility, software, artificial intelligence, and other relevant technical fields. Depending on the device’s intended purpose, medical specialists from the relevant clinical field are also involved.

“When assessing the safety and conformity of an EEG device, expertise from a wide range of disciplines may come together – from neurologists and other clinical experts to specialists in biomedical engineering, electrical safety, electromagnetic compatibility, software and cybersecurity. It is precisely this interdisciplinary approach that enables a comprehensive assessment of a medical device,” explains Peter Kramar, PhD, Director of Medical Device Certification at SIQ.

As devices become increasingly connected, there can be no compromise on safety

All these areas of expertise are becoming increasingly interconnected in modern medical devices, which are growing more complex and increasingly dependent on software and connectivity. Many devices are now connected to the cloud via the internet and use technologies such as artificial intelligence. There is also a growing number of active medical devices that connect wirelessly to smartphones and other devices.

As connectivity increases, cybersecurity is becoming an increasingly important aspect of ensuring safety. Medical devices must be protected against unauthorised access, cyberattacks and other cyber threats, as these can affect not only the operation of the device but also user safety and data protection.

For electronic and wirelessly connected medical devices, electromagnetic compatibility and efficient use of the radio spectrum must also be ensured. A medical device must operate reliably without interfering with other devices in its environment. At the same time, wireless communication functionalities must be appropriately tested and meet requirements that ensure their safe and reliable operation.

Artificial intelligence offers significant benefits but requires new safety mechanisms

Artificial intelligence is also playing an increasingly important role. More and more manufacturers are incorporating AI-based solutions into existing medical devices or using AI to enhance their functionality. This opens up new opportunities for the development and use of medical devices, while at the same time introducing new challenges relating to their safety, reliability and performance.

With the implementation of the European Artificial Intelligence Act (AI Act, Regulation (EU) 2024/1689), medical devices incorporating artificial intelligence will also be subject to additional requirements. In addition to existing medical device requirements, manufacturers will need to address aspects relating to safety, performance and the management of risks arising from the use of artificial intelligence. This will further reinforce the need for a comprehensive and interdisciplinary approach to the development, assessment and conformity assurance of modern medical devices.

Regulation is essential for patient safety and continued development

The safety of a medical device is the result of combining regulatory requirements, clinical and other specialist expertise, and various areas of technical testing. With its expertise and broad range of services, SIQ supports manufacturers in addressing different aspects of conformity assessment and safety verification – from MDR conformity assessment to electrical safety, electromagnetic compatibility and cybersecurity testing.

The ultimate goal is to ensure that the device fulfils its intended purpose and that its use is safe and reliable for both patients and healthcare professionals. Cooperation between experts from different disciplines and independent assessment are essential in achieving this goal, enabling an objective evaluation of all relevant aspects of medical device safety.