According to Article 2, number 5 of Regulation (EU) 2017\/745, an implantable medical device is a product intended to be introduced into the body through a clinical procedure and to remain there after the procedure; this also applies if it is intended to be fully or partially absorbed. Furthermore, any product that is partially introduced into the human body through a clinical procedure and is intended to remain there for at least 30 days after the procedure is also considered implantable. The definition thus refers to the procedure and residence time, not to the material or mode of action. This leads to increased requirements for classification, clinical evidence, traceability, and patient information. <\/p>\n
Rule 8 of Annex VIII generally classifies all implantable products and all surgically invasive products intended for long-term use as Class IIb. The exceptions predominantly lead upwards: Class III applies, among other things, when used in direct contact with the heart, central circulatory system, or central nervous system, in cases of biological effect or extensive absorption, chemical changes in the body, drug delivery, active implantable products and their accessories, breast implants and surgical meshes, total and partial joint prostheses, as well as intervertebral disc replacements and products with spinal contact. For dental implants, the rule provides for classification as Class IIa. <\/p>\n
The class determines the conformity assessment procedure involving a Notified Body. For implantable Class III products and certain Class IIb products, Article 54 additionally provides for a consultation procedure for clinical evaluation by an expert panel. For implantable products and Class III products, Article 32 also requires the preparation of a summary of safety and clinical performance, which must be made publicly available through the European database. <\/p>\n
Article 61, paragraph 4 tightens the evidence requirement: Clinical investigations must be conducted for implantable products and Class III products. A waiver is only permissible if the product resulted from modifications to a product already placed on the market by the same manufacturer, if equivalence has been demonstrated according to Annex XIV, point 3, and confirmed by the Notified Body, and if the clinical evaluation of the marketed product is sufficient for the demonstration. In this case, the Notified Body verifies whether the post-market clinical follow-up plan is suitable and provides for post-market studies. <\/p>\n
Article 18 obliges the manufacturer to provide identification details with the product, including product name, serial number, lot number, unique device identification, model, as well as the manufacturer’s name, address, and website, along with warnings and precautions regarding foreseeable external influences, medical examinations, and environmental conditions, as well as information on the expected lifespan and necessary follow-up measures. This information must be understandable to laypersons and kept up-to-date. Additionally, an implant card with the identification details must be supplied. Exempt from these obligations under Article 18, paragraph 3 are, among others, sutures, staples, dental fillings, braces, dental crowns, screws, wedges, dental or bone plates, wires, pins, clamps, and connectors. <\/p>\n
Every implantable product is invasive, but not every invasive product is implantable: the decisive factor is remaining in the body after the procedure or the 30-day threshold for partial introduction. A long-term surgically invasive product that is removed after the procedure is treated similarly under Rule 8 but does not necessarily meet the definition of an implantable product; the obligations under Article 18 are linked to the definition and not to the rule. <\/p>\n
An active implantable product, which additionally meets the characteristics of Article 2, number 4 and falls into Class III according to Rule 8, must be distinguished from an implantable product; such products were historically subject to Directive 90\/385\/EEC. Accessory components such as screws, wedges, plates, and instruments are sometimes explicitly excluded from upgrading in Rule 8 and must therefore be evaluated separately. <\/p>\n
Studies involving implantable products are characterized by long observation horizons. Endpoints typically concern implant survival, revision rate, migration, material behavior, infections, and functional outcomes; post-market surveillance must be designed to capture late events. Because blinding is rarely possible, particular importance is given to the definition of objective endpoints, independent event assessment, and complete follow-up. <\/p>\n
In addition, there are documentation obligations directly related to studies: the assignment of batch and serial numbers to participants, the recording of explantations, and the linking of study data with post-market surveillance and the summary of safety and clinical performance. Full-service CROs like Mediconomics support manufacturers in setting up long-term post-market surveillance concepts, registry connections, and traceability requirements in such a way that the collected data supports the tightened evidence requirements. <\/p>\n
When is a partially introduced product considered implantable?<\/strong><\/p>\n If it is intended to remain in the body for at least 30 days after the clinical procedure. Article 2, number 5 refers to the manufacturer’s intended purpose, not the residence time in individual cases. <\/p>\n Are clinical investigations mandatory for implants?<\/strong><\/p>\n Generally, yes. Article 61, paragraph 4 requires clinical investigations for implantable products and Class III products; exceptions require a modified product from the same manufacturer, confirmed proof of equivalence, and sufficient existing clinical evaluation. <\/p>\n For which implants is the implant card not required?<\/strong><\/p>\n For the products listed in Article 18, paragraph 3, including, among others, sutures, staples, dental fillings, braces, dental crowns, screws, wedges, dental or bone plates, wires, pins, clamps, and connectors.<\/p>\n According to Article 2, number 5 of Regulation (EU) 2017\/745, an implantable medical device is a product intended to be introduced into the body through a clinical procedure and to remain there after the procedure; this also applies if it is intended to be fully or partially absorbed. Furthermore, any product that is partially introduced […]<\/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-7781","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\/7781","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\/7781\/revisions"}],"wp:attachment":[{"href":"https:\/\/mediconomics.com\/en\/wp-json\/wp\/v2\/media?parent=7781"}],"wp:term":[{"taxonomy":"glossary-cat","embeddable":true,"href":"https:\/\/mediconomics.com\/en\/wp-json\/wp\/v2\/glossary-cat?post=7781"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}Regulatory References<\/h2>\n
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