According to Article 2 of Regulation (EU) 2017\/745, a medical device is any instrument, apparatus, appliance, software, implant, reagent, material or other article intended by the manufacturer to be used, alone or in combination, for human beings for one or more specific medical purposes. Its principal intended action in or on the human body is not achieved by pharmacological, immunological or metabolic means, but which may be assisted in its function by such means. The intended purpose of the manufacturer is decisive for the classification and the regulatory obligations.<\/p>\n
The MDR names as medical purposes, among others, diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of disease as well as investigation, replacement or modification of the anatomy or of a physiological or pathological process or state. Medical devices can be very different: from simple non-invasive products via software and instruments to active or implantable products. The decisive factor is not the external form, but the use specified by the manufacturer and the principal mode of action.<\/p>\n
The legal definition also includes devices that provide information by means of in vitro examination of specimens derived from the human body. However, for this special product group, Regulation (EU) 2017\/746 on in vitro diagnostic medical devices, IVDR, applies. Regulatory qualification should occur early because it determines classification, technical documentation and conformity assessment. For borderline products, composition, intended purpose and mode of action are to be examined carefully.<\/p>\n
The MDR divides medical devices into classes I, IIa, IIb and III, taking into account the intended purpose of the devices and their inherent risks. Annex VIII contains the classification rules. They take into account, among other things, whether a device is invasive or active, how long it is used, what body contact it has and what function it fulfills. The class is therefore not freely selectable and does not merely follow technical complexity; it results from the intended purpose and the applicable rules.<\/p>\n
A conformity assessment procedure is required prior to placing on the market. With this, the manufacturer demonstrates that the general safety and performance requirements are met and draws up the technical documentation. Depending on the class and procedure, a notified body is involved, which, for example, assesses the quality management system and parts of the technical documentation. For class I devices, simplified procedures apply under certain conditions; with higher risk, the independent assessment by a notified body assumes a central role. Following a successful conformity assessment, the CE marking may be affixed.<\/p>\n
Clinical evaluation is a planned and documented process in which clinical data are continuously generated, collected, evaluated and analyzed. It is intended to demonstrate that safety and clinical performance, including clinical benefit, are sufficiently proven when used as intended. Article 61 and Annex XIV of the MDR form the regulatory framework for this. Existing data, scientific literature, data from an equivalent device and proprietary clinical data can be relevant, but must be evaluated in a methodologically appropriate manner.<\/p>\n
If the data are not sufficient, a clinical investigation may be necessary. ISO 14155 describes good clinical practice for such investigations. Post-market data and data from post-market clinical follow-up flow into the update of the clinical evaluation.<\/p>\n
A medicinal product differs above all via its principal mode of action. If a product achieves its principal intended action pharmacologically, immunologically or metabolically, its classification as a medicinal product must be examined. With combinations, medicinal product and medical device requirements can interact; the qualification depends on the respective product and its intended purpose. A medical device is thus not simply every product that is used in healthcare.<\/p>\n
An in vitro diagnostic medical device examines human samples obtained outside the body and provides information, for example concerning a physiological or pathological state. For this, the IVDR applies as a specific legal framework. A product defect, on the other hand, designates a deviation or a problem of the product itself, for example a malfunction or faulty labeling. It is not an adverse event that affects a person. However, a product defect can contribute to an adverse event; both issues must then be documented and evaluated separately.<\/p>\n
For clinical trials with medical devices, intended purpose, risk class, stage of development and research objective must be clearly described prior to the start. These points influence the protocol, clinical endpoints, safety monitoring, the qualification of the trial sites and the regulatory submission strategy. Authorities and notified bodies pay attention to the traceability of the clinical evidence, to the protection of the trial participants and to the connection between trial data, risk management and clinical evaluation. The investigation of product defects also requires clearly separated processes.<\/p>\n
Full-service CROs such as Mediconomics support the planning of clinical investigations according to ISO 14155, trial site management, monitoring and data management as well as the preparation of clinical data for the clinical evaluation. Further services include the creation and maintenance of trial documents, support with safety and product defect processes as well as medical writing for clinical investigation reports. In this way, the requirements from MDR, clinical evidence and operational conduct are combined on a project basis.<\/p>\n
Is every software in healthcare a medical device?<\/strong><\/p>\n No. Decisive is the medical intended purpose specified by the manufacturer. Software can be a medical device if it fulfills these conditions; general administrative software does not fulfill them solely through its use in healthcare.<\/p>\n What do the classes I, IIa, IIb and III mean?<\/strong><\/p>\n They are the risk classes of the MDR. The classification follows the rules of Annex VIII and takes into account in particular the intended purpose and inherent risks of the product.<\/p>\n Is a product defect an adverse event?<\/strong><\/p>\n No. A product defect concerns the product. An adverse event concerns a medical observation in a person. A defect can cause an event, yet both terms remain separate.<\/p>\n According to Article 2 of Regulation (EU) 2017\/745, a medical device is any instrument, apparatus, appliance, software, implant, reagent, material or other article intended by the manufacturer to be used, alone or in combination, for human beings for one or more specific medical purposes. Its principal intended action in or on the human body is […]<\/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":[],"class_list":["post-6690","glossary","type-glossary","status-publish","hentry"],"acf":[],"related_terms":"","external_url":"","internal_reference_id":"","_links":{"self":[{"href":"https:\/\/mediconomics.com\/en\/wp-json\/wp\/v2\/glossary\/6690","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":1,"href":"https:\/\/mediconomics.com\/en\/wp-json\/wp\/v2\/glossary\/6690\/revisions"}],"predecessor-version":[{"id":7471,"href":"https:\/\/mediconomics.com\/en\/wp-json\/wp\/v2\/glossary\/6690\/revisions\/7471"}],"wp:attachment":[{"href":"https:\/\/mediconomics.com\/en\/wp-json\/wp\/v2\/media?parent=6690"}],"wp:term":[{"taxonomy":"glossary-cat","embeddable":true,"href":"https:\/\/mediconomics.com\/en\/wp-json\/wp\/v2\/glossary-cat?post=6690"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}Regulatory references<\/h2>\n
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