BSI Medical Device Blog 2019

Harmonization of standards under the regulations for medical devices moves forward slowly

The European MDR and IVDR have specific roles for harmonized standards in demonstrating conformity. In order for a standard to be harmonized under the regulations, a standardization request has to be agreed between the European Commission and the European Standards organizations. The draft of this standardization request has now been published by the European Commission.

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The third edition of ISO 14971 and its relation to other standards

The second edition of ISO 14971 was published in 2007 and the third edition is expected in 2019. ISO 14971 provides a generic process for risk management of all kinds of medical devices. Due to its generic character, this standard needs to be applied in combination with other process standards and device-specific standards in order to ensure the safety of the medical device and to demonstrate compliance with all regulatory requirements.

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Medical device risk management by ISO 14971: Top management

The third edition of medical devices risk management standard ISO 14971 will be published in 2019. There will be a transitional period of three years following publication to allow all stakeholders to adapt to the requirements in the new edition. The commitment of top management is indispensable for proper risk management. Large corporations can consist of separate entities (such as divisions or business units), where each entity can have its own risk management process and its own quality management system. In such cases, top management refers to those individuals who direct and control that entity.

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Global harmonization, its work items and clinical evaluation

The International Medical Device Regulators Forum (IMDRF) is a voluntary group of worldwide medical device regulators working with the aim of accelerating international medical device regulatory harmonization. IMDRF was formed in 2011, replacing the Global Harmonization Task Force (GHTF), which had its first meeting in 1993, formed to foster the global harmonization of medical device regulation. During its years of operation, GHTF issued numerous guidance documents covering medical device premarket evaluation, post-market surveillance and vigilance, quality systems, auditing and clinical studies.

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AI: incorporation into medical devices and regulatory developments

There are several drivers for the incorporation of AI into medical devices. In areas where the quantity or complexity of data is high assistance to a human interpreter can be provided by systems that can suggest diagnoses, or can retrieve cases which are in some sense, similar. This can support differential diagnosis, particularly for rare forms of some disorder; it is more than simply a retrieval system, as the criteria for matching is likely to be quite difficult to construct.

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How is AI being used in medicine and healthcare?

Virtually all active diagnostic devices that use software to interpret sensor data could be expected to benefit from incorporating AI into their controlling software. Devices that are deemed to be “good enough” might, of course, not need to be improved. But in principle, devices that can capture and make use of more information about a patient’s immediate physiological state, or emerging response to treatment, might be expected to yield better patient outcomes.

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Can systems based on AI be certified for medical use?

The answer to this question needs to consider the types of algorithm that are used in the AI system. Devices that make use of sensor data that is captured from patients might be expected to have input/output mappings that are very well defined. However, as the number of sensor measurements increases, or the history over which a signal is analysed (i.e. time-scale), there is arguably an increased possibility of unexpected device behaviour.

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Aligning international and European standards on packaging for terminally-sterilized medical devices

The EN 868 series of European standards on packaging for terminally-sterilized medical devices has been revised. One of the intentions of the revisions of these standards was to increase the link with EN ISO 11607-1. In particular removing duplication and overlap and aligning with EN ISO 11607 in regards to general principles; terms and definitions; and information on precision and bias, repeatability and reproducibility for test methods.

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Therapeutic nanoparticles

Nanoparticles can be designed to produce a therapeutic effect without direct application of drugs. Most of these effects are brought about by having the particle designed to create locally, free radicals or energetic electrons to kill specific cell types. There is a further possible way to treat diseased tissue by destroying it with local heat produced by nanoparticles that are designed to get warm in radiofrequency fields or infra-red light.

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