Under Article 2(4) of Regulation (EU) 2017\/745, an active medical device is a device whose operation depends on an energy source, except for energy generated for that purpose by the human body or by gravity, and which acts by changing the density of, or converting, that energy. A device that transfers energy, substances, or other elements between an active device and the patient without causing a significant change in energy, substances, or parameters is explicitly not considered an active device. Under the same provision, software is also considered an active device. Classification as \u201cactive\u201d is therefore a legal designation based on the principle of operation, not a determination that a device has a mains connection. <\/p>\n
Two characteristics must be present. First, operation must depend on an external energy source; an instrument operated purely mechanically by muscle power or gravity is therefore not active. Second, the device must act by changing the density of, or converting, that energy. This excludes mere transmission: a connecting tube or cable that transfers energy without significant change remains passive, even if it is part of an active system. <\/p>\n
For classification purposes, Annex VIII, Chapter I distinguishes two functional subgroups. Under Section 2.4, an active therapeutic device is intended to maintain, modify, replace, or restore biological functions or structures in connection with the treatment or alleviation of a disease, injury, or disability. Under Section 2.5, an active medical device for diagnostic and monitoring purposes is intended to provide information for the detection, diagnosis, monitoring, or treatment of physiological conditions, health status, diseases, or congenital malformations. <\/p>\n
Rules 9 to 13 of Annex VIII are directly linked to whether a device is active. Under Rule 9, active therapeutic devices intended to administer or exchange energy are generally Class IIa, and Class IIb if the type, density, and site of application of the energy may present a potential hazard; devices that drive, control, or directly influence the performance of active implantable devices are Class III. Rule 10 classifies diagnostic and monitoring active devices as Class IIa or IIb depending on energy absorption, vital-parameter monitoring, and the risk situation. Rule 11 applies to software, Rule 12 to active devices intended to administer or remove substances, and Rule 13 to all other active devices that fall into Class I. <\/p>\n
For demonstrating compliance with the general safety and performance requirements, \u201cactive\u201d status entails additional test content: electrical safety, electromagnetic compatibility, alarms, energy management, software and cybersecurity aspects, interactions with other devices, and behavior in the event of a fault. Annex I, Chapter II contains specific requirements for devices with electronic programmable systems, protection against radiation, and active devices with an energy source. <\/p>\n
\u201cActive\u201d and \u201cinvasive\u201d are independent characteristics. An active device can operate outside the body, an invasive device can be entirely passive, and a device can be both\u2014for example, a powered catheter. Classification as an active device determines the applicable Rules 9 to 13, while invasiveness determines Rules 5 to 8; where multiple rules apply, Annex VIII requires assignment to the higher class. <\/p>\n
Active implantable devices must be distinguished from active devices: under Rule 8, an active implantable device is classified as Class III and historically fell under Directive 90\/385\/EEC. Accessories must be considered separately: under Article 2(2), they are classified independently, so a passive accessory for an active device is not automatically considered active. Although software is, by definition, an active device, its classification follows the specific Rule 11; product-specific aspects are addressed in the entry on medical device software. <\/p>\n
For active devices, device technology and operation shape the study design. The clinical investigation plan must define the hardware and software version used, settings and energy parameters, calibration, user training, and environmental conditions so that results can be attributed to a defined device configuration. Safety endpoints typically relate to energy-related events, alarm behavior, device failures, and use errors; device deficiencies must also be captured and classified in addition to adverse events. <\/p>\n
Because active devices undergo software and hardware changes over their lifecycle, linking data to specific versions is a key quality issue for subsequent usability. Full-service CROs such as Mediconomics support manufacturers in translating technical device characteristics into clinical investigation plans, user training, and data collection instruments, and in documenting the attribution of events, device deficiencies, and version status in an audit-ready manner. <\/p>\n
Is a battery-powered device always an active device?<\/strong><\/p>\n Only if it converts the energy or changes its density and operation depends on that energy source. A device that merely transfers energy without significant change is not an active device under Article 2(4). <\/p>\n Why is software considered an active device?<\/strong><\/p>\n Article 2(4) explicitly states this. For classification, however, Rule 11 of Annex VIII is decisive, as it is based on the significance of the information provided for diagnostic or therapeutic decisions. <\/p>\n How is an accessory to an active device classified?<\/strong><\/p>\n Independently. Under Article 2(2) and the classification rules in Annex VIII, accessories are assessed separately from the main device; the class of the active device does not automatically apply. <\/p>\n Under Article 2(4) of Regulation (EU) 2017\/745, an active medical device is a device whose operation depends on an energy source, except for energy generated for that purpose by the human body or by gravity, and which acts by changing the density of, or converting, that energy. A device that transfers energy, substances, or other […]<\/p>\n","protected":false},"author":10,"featured_media":0,"parent":0,"template":"","meta":{"_acf_changed":false,"site-sidebar-layout":"default","site-content-layout":"","ast-site-content-layout":"default","site-content-style":"default","site-sidebar-style":"default","ast-global-header-display":"","ast-banner-title-visibility":"","ast-main-header-display":"","ast-hfb-above-header-display":"","ast-hfb-below-header-display":"","ast-hfb-mobile-header-display":"","site-post-title":"","ast-breadcrumbs-content":"","ast-featured-img":"","footer-sml-layout":"","ast-disable-related-posts":"","theme-transparent-header-meta":"","adv-header-id-meta":"","stick-header-meta":"","header-above-stick-meta":"","header-main-stick-meta":"","header-below-stick-meta":"","astra-migrate-meta-layouts":"default","ast-page-background-enabled":"default","ast-page-background-meta":{"desktop":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"ast-content-background-meta":{"desktop":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"footnotes":""},"glossary-cat":[24],"class_list":["post-7783","glossary","type-glossary","status-publish","hentry","glossary-cat-medizinprodukte-ivd"],"acf":[],"related_terms":"","external_url":"","internal_reference_id":"","_links":{"self":[{"href":"https:\/\/mediconomics.com\/en\/wp-json\/wp\/v2\/glossary\/7783","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/mediconomics.com\/en\/wp-json\/wp\/v2\/glossary"}],"about":[{"href":"https:\/\/mediconomics.com\/en\/wp-json\/wp\/v2\/types\/glossary"}],"author":[{"embeddable":true,"href":"https:\/\/mediconomics.com\/en\/wp-json\/wp\/v2\/users\/10"}],"version-history":[{"count":0,"href":"https:\/\/mediconomics.com\/en\/wp-json\/wp\/v2\/glossary\/7783\/revisions"}],"wp:attachment":[{"href":"https:\/\/mediconomics.com\/en\/wp-json\/wp\/v2\/media?parent=7783"}],"wp:term":[{"taxonomy":"glossary-cat","embeddable":true,"href":"https:\/\/mediconomics.com\/en\/wp-json\/wp\/v2\/glossary-cat?post=7783"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}Regulatory References<\/h2>\n
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