Under Article 2(12) of Regulation (EU) 2017\/745, the intended purpose is the use for which a product is intended according to the manufacturer\u2019s information on the label, in the instructions for use, in advertising or sales material or statements, and in the information provided for the clinical evaluation. It is therefore a legally defined manufacturer\u2019s declaration, not merely a product description. It determines the product\u2019s qualification as a medical device, its classification, the scope of the required clinical evidence, and the benchmark for risk management and post-market surveillance. Because the legal definition lists several information sources as equally authoritative, all of these sources must describe the same use. <\/p>\n
A sound intended purpose specifies the medical purpose within the meaning of Article 2(1)\u2014for example diagnosis, prevention, monitoring, prediction, prognosis, treatment, or alleviation\u2014and assigns it to a specific clinical situation. It also includes the target population with indications and contraindications, the intended user with qualifications and prior experience, the use environment from intensive care to home use, the body site or tissue contact, the duration of use, and the principle of operation. Only this information makes the intended purpose verifiable. <\/p>\n
The intended purpose must be distinguished from the indication: the indication describes the disease or condition for which the product is used, whereas the intended purpose also covers the user, environment, duration, and mode of operation. These additional details are decisive for classification because Annex VIII links to characteristics such as duration of use, invasiveness, body contact, or the significance of a software-supported decision. For medical device software, the classification outcome under Rule 11 follows directly from the question of which decisions the provided information supports. <\/p>\n
If the intended purpose is expanded or shifted\u2014for example through a new patient group, a new user group, an additional body site, or a new diagnostic claim\u2014this is not, from a regulatory perspective, an editorial change. A change may shift the classification, require a different conformity assessment procedure, trigger new clinical evidence, and require updates to the risk analysis, usability evidence, labelling, and instructions for use. For legacy devices under the transitional provisions, a significant change to the intended purpose is also considered a loss of the transitional effect under Article 120(3c). <\/p>\n
Of practical relevance is the silent expansion: if sales documents, training, user portals, or trade fair statements suggest a use that is not covered by the instructions for use, that statement becomes part of the intended purpose under Article 2(12). The manufacturer is then liable for evidence it has never generated. Consistency checks across all materials are therefore a regulatory control point, not a marketing issue. <\/p>\n
A claim is a single statement about the product\u2019s characteristics, performance, or benefit. It must be supported by the intended purpose and substantiated by data; the intended purpose remains the framework, and the claim is a statement within that framework. Annex I, Section 23 also prohibits misleading information on intended purpose, safety, and performance. A statement that goes beyond the evidence is therefore not a communication error, but a non-conformity. <\/p>\n
Off-label use lies outside the intended purpose and is carried out by a user under their own responsibility; it does not expand the manufacturer\u2019s intended purpose, but it may be relevant for vigilance and must be considered in the risk assessment as reasonably foreseeable misuse. Also to be distinguished is a product without a medical intended purpose under Annex XVI, which is subject to its own rules precisely because it lacks a medical purpose, whereas classification as a medical device overall is addressed in the entry \u201cmedical device\u201d. <\/p>\n
The intended purpose is the reference point for every clinical investigation of a medical device. It determines the population to be studied, the user groups, and the use environment and thus the inclusion and exclusion criteria, and it defines which endpoints actually reflect the claimed clinical benefit. If the study setting deviates from the intended purpose\u2014for example, trained specialists in a study of a product intended for lay users\u2014the results will only support the subsequent evidence to a limited extent. <\/p>\n
Conversely, study results feed back into the intended purpose: they can confirm it, restrict it, or make it necessary to refine the indication, user profile, or warnings. Full-service CROs such as Mediconomics support manufacturers in formulating a verifiable intended purpose before the study begins, aligning the protocol and endpoints with it, and ensuring consistency between study documentation, clinical evaluation, labelling, and instructions for use. <\/p>\n
Where is the intended purpose legally defined?<\/strong><\/p>\n In Article 2(12) of Regulation (EU) 2017\/745. The definition explicitly includes the information on the label, in the instructions for use, in advertising and sales material, and the manufacturer\u2019s information in the clinical evaluation. <\/p>\n Does an advertising statement count as part of the intended purpose?<\/strong><\/p>\n Yes. Advertising and sales statements are part of the legal definition. A statement that suggests an undocumented use effectively expands the intended purpose and must be supported by evidence. <\/p>\n What follows from a change to the intended purpose?<\/strong><\/p>\n Classification, conformity assessment procedure, clinical evidence, risk management, usability, as well as labelling and instructions for use must be reviewed. For legacy devices, a significant change to the intended purpose may cause the transitional provision under Article 120 to cease to apply. <\/p>\n Under Article 2(12) of Regulation (EU) 2017\/745, the intended purpose is the use for which a product is intended according to the manufacturer\u2019s information on the label, in the instructions for use, in advertising or sales material or statements, and in the information provided for the clinical evaluation. It is therefore a legally defined manufacturer\u2019s […]<\/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-7784","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\/7784","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\/7784\/revisions"}],"wp:attachment":[{"href":"https:\/\/mediconomics.com\/en\/wp-json\/wp\/v2\/media?parent=7784"}],"wp:term":[{"taxonomy":"glossary-cat","embeddable":true,"href":"https:\/\/mediconomics.com\/en\/wp-json\/wp\/v2\/glossary-cat?post=7784"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}Regulatory References<\/h2>\n
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