In medical device law, an established technology is a product group with a simple, widely used design that has remained stable over a long period, a well-known safety profile, known performance characteristics, and a long market history. The MDR uses the term but does not define it itself. The MDCG describes these four shared characteristics in order to classify the clinical evidence requirements.<\/p>\n
The design must be comparatively simple, common, and only minimally further developed. This does not mean every product that has been available for years, but rather a generic product group whose basic construction and use have remained essentially stable. Frequent technical changes argue against classifying it as an established technology.<\/p>\n
In addition, there must be a well-known safety profile without previous safety-relevant issues, known clinical performance characteristics, and a long market history. The group should also be used as a standard of care, without major changes in indication or the medical comparator. All characteristics must be considered together; none replaces the others.<\/p>\n
The term can explain why, for certain products, a different scope of evidence may be justifiable than for a new, implantable, or technically complex solution. However, the clinical evaluation remains based on sufficient clinical data and compliance with the relevant safety and performance requirements. Established status replaces neither the systematic literature review nor the evaluation of the manufacturer\u2019s own post-market surveillance data.<\/p>\n
For products that have been marketed for a long time, existing clinical experience, PMCF results, and data from similar products may be relevant. However, the quality of these sources must still be assessed. If new risks, a changed indication, or a new technical implementation creates an open question, additional evidence may be required even though the underlying technology has been known for a long time.<\/p>\n
The classification must always be justified on a product-specific basis. Naming a generic category or the duration of distribution is not sufficient if, for example, new materials, new sterilisation processes, or changed user interfaces alter the safety or performance assumptions. The manufacturer should substantiate the four characteristics with documentation on design history, post-market surveillance, and clinical practice.<\/p>\n
The state of the art also remains dynamic for established technologies. An established bone plate may be part of a treatment option whose indication or surgical practice has evolved. The known underlying technology therefore does not limit the obligation to assess new information from vigilance, PMCF, and the scientific literature against current clinical practice.<\/p>\n
Accordingly, the assessment should document why the examples cited in the article, or a comparable product, actually share the specific features of the manufacturer\u2019s own technology. A mere reference to the material group or a well-known product name does not support this conclusion.<\/p>\n
Established technology is not a free pass. The relevant link is to the products listed in Article 61(6)(b) MDR and to similar products, not to a blanket exemption for familiar medical devices. Even there, the clinical evaluation continues to depend on sufficient data and, where applicable, product-specific Common Specifications.<\/p>\n
The term is also distinct from legacy devices. A legacy device is described by its previous CE marking and transitional status; an established technology by the characteristics of a product group. A legacy device may belong to an established technology, but it does not have to. Conversely, an established product is not a legacy device solely because of that characteristic.<\/p>\n
In study planning, classification as an established technology does not in itself make the need for a clinical investigation redundant, but it does sharpen the evidence strategy. The team must document which of the four characteristics are substantiated for the specific product group, which clinical data are already available, and which remaining questions a PMCF activity or a new study is intended to answer. It is particularly important to assess carefully whether design changes or a new user group still allow previous experience to be transferred.<\/p>\n
Full-service CROs such as Mediconomics support manufacturers with evidence mapping, the assessment of literature and use data, and the development of a PMCF plan for products with a long market history. They link the clinical rationale with the risk management file, Clinical Evaluation Report, and protocol so that reliance on an established technology is not detached from the specific performance and safety data.<\/p>\n
Is a long market presence sufficient for an established technology?<\/strong><\/p>\n No. The MDCG also cites a stable, simple design, a well-known safety profile, and known clinical performance characteristics as shared properties.<\/p>\n Is an established technology always exempt from a clinical investigation?<\/strong><\/p>\n No. The exemption depends on the MDR requirements; the classification may influence the scope of evidence, but it does not remove the obligation to have sufficient clinical data.<\/p>\n Can a new software update still belong to an established technology?<\/strong><\/p>\n That depends on whether the change affects the stable basic design, clinical performance, or safety profile. No blanket classification can be derived from this.<\/p>\n In medical device law, an established technology is a product group with a simple, widely used design that has remained stable over a long period, a well-known safety profile, known performance characteristics, and a long market history. The MDR uses the term but does not define it itself. The MDCG describes these four shared characteristics […]<\/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-8052","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\/8052","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\/8052\/revisions"}],"wp:attachment":[{"href":"https:\/\/mediconomics.com\/en\/wp-json\/wp\/v2\/media?parent=8052"}],"wp:term":[{"taxonomy":"glossary-cat","embeddable":true,"href":"https:\/\/mediconomics.com\/en\/wp-json\/wp\/v2\/glossary-cat?post=8052"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}Regulatory References<\/h2>\n
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