Risk classes are the four categories into which medical devices are classified under Article 51(1) of Regulation (EU) 2017\/745, according to their intended purpose and the risks associated with them: Class I, Class IIa, Class IIb and Class III. Classification is based on the rules in Annex VIII and determines how extensive the conformity assessment is, whether a Notified Body must be involved, what clinical evidence is expected, and how frequently safety reporting is required. The class is therefore not a label, but the key determinant of the overall regulatory effort. <\/p>\n
Class I covers low-risk products, such as dressings for superficial wounds, walking aids, wheelchairs or spectacle frames. Class IIa includes medium-risk products, for example hearing aids, dental filling materials, suction systems or ultrasound devices for diagnostic purposes. Class IIb concerns higher-risk products such as ventilators, infusion pumps, dialysis machines or surgical meshes. Class III includes the highest-risk products, in particular vascular stents, heart valves, breast implants, total joint prostheses, products incorporating an ancillary medicinal substance, and products made from non-viable human tissues or cells. Depending on its intended purpose, a medical device may fall into different classes; therefore, classification is always product-specific rather than based on product type. <\/p>\n
Within Class I, practice distinguishes three special cases arising from Article 52(7), designated by the abbreviations Is, Im and Ir. Is refers to products placed on the market in a sterile condition, Im to products with a measuring function, and Ir to reusable surgical instruments. In these three cases, contrary to the principle of self-declaration, a Notified Body must be involved; however, its assessment is strictly limited: for Is, to the establishment and maintenance of sterility; for Im, to conformity with the metrological requirements; and for Ir, to aspects of reusability, in particular cleaning, disinfection, sterilisation, maintenance, functional testing and the associated instructions for use. If more than one special case applies, the requirements apply cumulatively. <\/p>\n
As the class increases, so do the requirements for clinical evidence. Under Article 61(4), clinical investigations are generally required for implantable devices and Class III devices; exceptions apply, among other things, to modifications of products already marketed by the same manufacturer and to devices that meet certain conditions of equivalence, as well as to the cases of established technologies referred to in Article 61(6). For Class III devices and implantable devices, Article 32 additionally requires a Summary of Safety and Clinical Performance, which is made publicly available via EUDAMED. For Class III and implantable devices, the consultation procedure with an expert panel under Annex IX, Section 5.1 may also apply. <\/p>\n
Post-market obligations are also tiered by class. Manufacturers of Class I devices prepare a post-market surveillance report in accordance with Article 85. From Class IIa onwards, the Periodic Safety Update Report under Article 86 is added; it must be updated at least every two years for Class IIa and at least annually for Classes IIb and III. For Class III devices and implantable devices, this report is submitted to the Notified Body via the electronic system and assessed by it. In addition, the scope of the Notified Body\u2019s surveillance assessment is determined by class in accordance with Annex IX, Section 3.5. <\/p>\n
The risk class is the outcome; classification is the route to get there: which of the 22 rules in Annex VIII applies depends on invasiveness, duration of use, energy source and specific device characteristics. The risk class should not be confused with the software safety classification under IEC 62304 or with Classes A to D for in vitro diagnostic devices under Regulation (EU) 2017\/746. Also to be considered separately is whether an item qualifies as a device at all: only once it has been established that a product falls within the scope of the Regulation is a class determined. In the event of a dispute over the class, the competent authority decides under Article 51(2). <\/p>\n
The class determines the starting point for every study plan. It decides whether a clinical investigation is legally required or whether an equivalence approach may be considered, how robust the endpoints must be, and what post-market follow-up can realistically be planned. For implantable devices and Class III devices, the study strategy must also support the Summary of Safety and Clinical Performance, which is publicly accessible. <\/p>\n
A later up-classification, for example due to an expansion of the intended purpose, can render previously sufficient evidence inadequate. Full-service CROs such as Mediconomics support manufacturers in aligning the clinical development strategy early with the correct class and planning the resulting evidence requirements realistically. <\/p>\n
Who determines the risk class?<\/strong><\/p>\n The manufacturer determines it based on the rules in Annex VIII and substantiates it in the technical documentation. In the event of disputes between the manufacturer and the Notified Body, the competent authority decides under Article 51(2). <\/p>\n Can a product\u2019s class change?<\/strong><\/p>\n Yes. Changes to the intended purpose, duration of use, invasiveness or materials can trigger a different rule. New interpretations or amended legal requirements can also lead to reclassification. <\/p>\n Do Class I devices require a Notified Body?<\/strong><\/p>\n In principle, no. Exceptions are devices placed on the market in a sterile condition, devices with a measuring function, and reusable surgical instruments; in these cases, the assessment is limited to the respective special aspect. <\/p>\n Risk classes are the four categories into which medical devices are classified under Article 51(1) of Regulation (EU) 2017\/745, according to their intended purpose and the risks associated with them: Class I, Class IIa, Class IIb and Class III. Classification is based on the rules in Annex VIII and determines how extensive the conformity assessment […]<\/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-7792","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\/7792","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\/7792\/revisions"}],"wp:attachment":[{"href":"https:\/\/mediconomics.com\/en\/wp-json\/wp\/v2\/media?parent=7792"}],"wp:term":[{"taxonomy":"glossary-cat","embeddable":true,"href":"https:\/\/mediconomics.com\/en\/wp-json\/wp\/v2\/glossary-cat?post=7792"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}Regulatory References<\/h2>\n
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