[{"data":1,"prerenderedAt":4},["ShallowReactive",2],{"guide-european-accessibility-act":3},"\u003Ch2 id=\"introduction\">1 Introduction\u003C/h2>\n\u003Cp>\n  The European Accessibility Act (\u003Ca href=\"#ref-eaa\">EAA\u003C/a>) is a law that aims to make everyday\n  products and services more accessible for people with disabilities. It covers items such as\n  computers, smartphones, websites, automated teller machines (s), e-books, and public transport\n  ticketing systems. The goal is to remove barriers so that everyone in the EU can access essential\n  tools and services more equally.\n\u003C/p>\n\u003Cp>\n  If a product falls within the scope of the \u003Ca href=\"#ref-eaa\">EAA\u003C/a>, it may need to meet\n  specific accessibility requirements. For example, smartphones and s might be required to offer\n  screen readers for users with visual impairments or provide clear audio instructions. Websites and\n  apps may need to function with assistive technologies and be easily navigable via keyboard. These\n  rules are intended to ensure that people with disabilities can use such products and services\n  independently and effectively.\n\u003C/p>\n\u003Cp>\n  Recently, some posts and presentations have suggested that the \u003Ca href=\"#ref-eaa\">EAA\u003C/a> will\n  apply to all medical devices, creating the impression of a new regulatory burden for the metech\n  industry. These messages often cite June 28th, 2025—the date the \u003Ca href=\"#ref-eaa\">EAA\u003C/a> comes\n  into force, Figure \u003Ca href=\"#fig-mdr-eaa-timeline\">1\u003C/a>—as a deadline for widespread compliance.\n\u003C/p>\n\u003Cp>\n  In this article, we argue that the actual impact of the \u003Ca href=\"#ref-eaa\">EAA\u003C/a> on medical\n  devices is far more limited.\n\u003C/p>\n\u003Cfigure>\n  \u003Cimg src=\"/guides/european-accessibility-act/timeline_EAA.svg\" />\n  \u003Cdiv id=\"fig-mdr-eaa-timeline\">\u003C/div>\n  \u003Cfigcaption>\n    Figure 1: Timeline of entry into force and application of the \u003Ca href=\"#ref-mdr\">MDR\u003C/a> and\n    \u003Ca href=\"#ref-eaa\">EAA\u003C/a>. The date of entry into force of a directive or regulation is the\n    date it becomes legally valid and part of EU law — i.e., when it is officially published and\n    exists. The date of application is the date when the directive’s or regulation’s rules start to\n    apply to manufacturers, authorities, and others — i.e., when compliance becomes mandatory.\n  \u003C/figcaption>\n\u003C/figure>\n\u003Cp>\n  To begin with, it is worth noting that the \u003Ca href=\"#ref-eaa\">EAA\u003C/a> places little emphasis on\n  medical devices. In fact, medical devices are not explicitly mentioned in the articles of the\n  directive. Instead, the only reference appears in a cautionary note within one of the recitals,\n  which acknowledges that some products or services covered by the\n  \u003Ca href=\"#ref-eaa\">EAA\u003C/a>—particularly assistive technologies—may also qualify as medical\n  devices:\n\u003C/p>\n\u003Cdiv class=\"quotationbox\">\n  \u003Cdiv class=\"boxsource\">\n    \u003Cp>\u003Ca href=\"#ref-eaa\">EAA\u003C/a>, Recital 51\u003C/p>\n  \u003C/div>\n  \u003Cp>\n    Products and services falling within the scope of this Directive do not automatically fall\n    within the scope of Council Directive 93/42/EEC (16). However, some assistive technologies which\n    are medical devices, might fall within the scope of that Directive.\n  \u003C/p>\n\u003C/div>\n\u003Cp>where \"assistive technology\" is defined in Article 3 as\u003C/p>\n\u003Cdiv class=\"quotationbox\">\n  \u003Cdiv class=\"boxtitle\">\n    \u003Cp>‘Assistive technology’\u003C/p>\n  \u003C/div>\n  \u003Cdiv class=\"boxsource\">\n    \u003Cp>\u003Ca href=\"#ref-eaa\">EAA\u003C/a>, Article 3(37)\u003C/p>\n  \u003C/div>\n  \u003Cp>\n    means any item, piece of equipment, service or product system including software that is used to\n    increase, maintain, substitute or improve functional capabilities of persons with disabilities\n    or for, alleviation and compensation of impairments, activity limitations or participation\n    restrictions.\n  \u003C/p>\n\u003C/div>\n\u003Cp>\n  In Recital 61, mentioned above, the \u003Ca href=\"#ref-eaa\">EAA\u003C/a> refers to the\n  \u003Ca href=\"#ref-mdd\">MDD\u003C/a> rather than the \u003Ca href=\"#ref-mdr\">MDR\u003C/a>, because at the time the\n  \u003Ca href=\"#ref-eaa\">EAA\u003C/a> entered into force (2019), the \u003Ca href=\"#ref-mdr\">MDR\u003C/a> had not yet\n  become applicable (see Figure \u003Ca href=\"#fig-mdr-eaa-timeline\">1\u003C/a>). In this context, one might\n  interpret the inclusion of the term \u003Cem>disability\u003C/em> in the \u003Ca href=\"#ref-mdr\">MDR\u003C/a> as a\n  possible attempt to align the medical device framework with the objectives of the\n  \u003Ca href=\"#ref-eaa\">EAA\u003C/a>. Notably, during the the transition from the\n  \u003Ca href=\"#ref-mdd\">MDD\u003C/a> to the \u003Ca href=\"#ref-mdr\">MDR\u003C/a> the definition of \"medical device\"\n  was revised—replacing the term \u003Cem>handycap\u003C/em> with \u003Cem>disability\u003C/em>, as shown in the redline\n  text below:\n\u003C/p>\n\u003Cdiv class=\"quotationbox\">\n  \u003Cdiv class=\"boxtitle\">\n    \u003Cp>‘Medical device’ (first pragraph)\u003C/p>\n  \u003C/div>\n  \u003Cdiv class=\"boxsource\">\n    \u003Cp>\u003Ca href=\"#ref-mdd\">MDD\u003C/a> vs \u003Ca href=\"#ref-mdr\">MDR\u003C/a>\u003C/p>\n  \u003C/div>\n  \u003Cp>\n    means any instrument, apparatus, appliance, \u003Cdel>material\u003C/del>\n    \u003Cspan class=\"added\">software, implant, reagent, material\u003C/span> or other article,\n    \u003Cdel\n      >whether used alone or in combination , intended by the manufacturer to be used, including the\n      software necessary for its proper application,\u003C/del\n    >\n    intended by the manufacturer to be used\u003Cspan class=\"added\">, alone or in combination,\u003C/span> for\n    human beings for \u003Cdel>the purpose of\u003C/del>\n    \u003Cspan class=\"added\">one or more of the following specific medical purposes\u003C/span>:\n  \u003C/p>\n  \u003Cul>\n    \u003Cli>\n      \u003Cp>\n        diagnosis, \u003Cspan class=\"added\">prevention\u003C/span>, monitoring,\n        \u003Cspan class=\"added\">prediction, prognosis,\u003C/span> treatment or alleviation of disease,\n      \u003C/p>\n    \u003C/li>\n    \u003Cli>\n      \u003Cp>\n        diagnosis, monitoring, treatment, alleviation of, or compensation for an injury or\n        \u003Cdel>handicap\u003C/del> \u003Cspan class=\"added\">disability,\u003C/span>\n      \u003C/p>\n    \u003C/li>\n    \u003Cli>\n      \u003Cp>\n        investigation, replacement or modification of the anatomy or of a physiological\n        \u003Cspan class=\"added\">or pathological\u003C/span> process \u003Cspan class=\"added\">or state,\u003C/span>\n      \u003C/p>\n    \u003C/li>\n    \u003Cli>\n      \u003Cp>\u003Cdel>control of conceptions,\u003C/del>\u003C/p>\n    \u003C/li>\n    \u003Cli>\n      \u003Cp>\n        \u003Cspan class=\"added\"\n          >providing information by means of in vitro examination of specimens derived from the\n          human body, including organ, blood and tissue donations,\u003C/span\n        >\n      \u003C/p>\n    \u003C/li>\n  \u003C/ul>\n  \u003Cp>\n    and which does not achieve its principal intended action in or on the human body by\n    pharmacological, immunological or metabolic means,\n    \u003Cspan class=\"added\">in or on the human body,\u003C/span> but which may be assisted in its function by\n    such means. […]\u003Cbr />\n  \u003C/p>\n\u003C/div>\n\u003Cp>\n  However, if we look at how the \u003Ca href=\"#ref-eaa\">EAA\u003C/a> defines \u003Cem>disability\u003C/em>, it becomes\n  clear that the idea of a direct link to the \u003Ca href=\"#ref-mdr\">MDR\u003C/a> wording is not supported.\n  The \u003Ca href=\"#ref-eaa\">EAA\u003C/a> defines disability as follows:\n\u003C/p>\n\u003Cdiv class=\"quotationbox\">\n  \u003Cdiv class=\"boxtitle\">\n    \u003Cp>‘Persons with disabilities’\u003C/p>\n  \u003C/div>\n  \u003Cdiv class=\"boxsource\">\n    \u003Cp>\u003Ca href=\"#ref-eaa\">EAA\u003C/a>, Article 3(37)\u003C/p>\n  \u003C/div>\n  \u003Cp>\n    means persons who have long-term physical, mental, intellectual or sensory impairments which in\n    interaction with various barriers may hinder their full and effective participation in society\n    on an equal basis with others.\n  \u003C/p>\n\u003C/div>\n\u003Cp>\n  This definition aligns with the United Nations Convention on the Rights of Persons with\n  Disabilities, adopted on 13 December 2006 (\u003Ca href=\"#ref-eaa\">EAA\u003C/a>, Recital 3), which, as\n  explained by the EU Commission in the \u003Ca href=\"#ref-accessibleeu\">AccessibleEU Report\u003C/a>, is\n  \u003Cem\n    >based on the social model of disability, which focuses not on a person’s medical condition, but\n    rather on their interaction with their environment, and the barriers created by society\u003C/em\n  >. This means that the definition of disability in the \u003Ca href=\"#ref-eaa\">EAA\u003C/a> includes\n  subjects that might not be considered clinically disabled.\n\u003C/p>\n\u003Cp>\n  It is important to keep this distinction in mind, as the key factor in determining the\n  applicability of the \u003Ca href=\"#ref-eaa\">EAA\u003C/a> is the intended \u003Cem>user\u003C/em> of the medical\n  device—not the target population (i.e., the patient). Some devices may have intended users who\n  qualify as disabled under the social model of disability, even if they are not clinically\n  disabled. This is especially relevant when the user is the patient or a layperson, rather than a\n  healthcare professional.\n\u003C/p>\n\u003Cp>\n  However, as this document will show, the scope of the \u003Ca href=\"#ref-eaa\">EAA\u003C/a> is narrowly\n  defined and applies primarily to types of products that are unlikely to correspond to most\n  currently marketed medical devices.\n\u003C/p>\n\u003Cp>\n  All in all, the \u003Ca href=\"#ref-eaa\">EAA\u003C/a> affects a narrow subset of medical devices. Most likely\n  devices which are assistive technologies intended to enable patients with disabilities accessing\n  and navigating today’s digital world. To clarify this point, in the rest of this article we\n  provide a detailed analysis of points 1 to 3 of Article 2 of the \u003Ca href=\"#ref-eaa\">EAA\u003C/a>, which\n  defines the scope of the Act. This analysis can be used within your QMS to justify why your device\n  does not fall under the EAA’s requirements.\n\u003C/p>\n\u003Cp>\n  Before we proceed, a final note. The \u003Ca href=\"#ref-eaa\">EAA\u003C/a> is a directive, meaning it must be\n  transposed into national law by each EU Member State. While the directive sets common goals, each\n  country can introduce additional or country-specific requirements during transposition. As a\n  result, compliance obligations may vary slightly depending on the Member State. Readers can find\n  the national implementing measures for the EAA at the following link:\n  \u003Ca href=\"https://eur-lex.europa.eu/legal-content/EN/NIM/?uri=CELEX:32019L0882\"\n    >EUR-Lex – National Transpositions of Directive 2019/882\u003C/a\n  >.\n\u003C/p>\n\u003Ch2 id=\"detailed-analysis-of-the-eaa-scope-article-2\">\n  2 Detailed analysis of the \u003Ca href=\"#ref-eaa\">EAA\u003C/a> scope (Article 2)\n\u003C/h2>\n\u003Cp>\n  In the following sections, we break down Article 2 of the \u003Ca href=\"#ref-eaa\">EAA\u003C/a>, presenting\n  each sentence of the article as a section or subsection heading, followed by a detailed analysis\n  in the corresponding body text. For each part, we also provide a qualitative likelihood that\n  medical devices currently on the market would fall under that specific element of the\n  \u003Ca href=\"#ref-eaa\">EAA\u003C/a>’s scope.\n\u003C/p>\n\u003Cp>\n  \u003Cstrong>2.1\u003C/strong> This Directive applies to the following products placed on the market after\n  28 June 2025\n\u003C/p>\n\u003Cp>\n  The \u003Ca href=\"#ref-eaa\">EAA\u003C/a> entered into force in 2019; however, its rules only begin to apply\n  to manufacturers, authorities, and other stakeholders from 28 June 2025, Figure\n  \u003Ca href=\"#fig-mdr-eaa-timeline\">1\u003C/a>. The opening sentence of Article 2(1) of the\n  \u003Ca href=\"#ref-eaa\">EAA\u003C/a> underscores this and provides an important clarification: the\n  regulation does not apply retroactively. As a result, devices that fall within the scope of the\n  act but were placed on the market before the application date (28 June 2025) are not subject to\n  its requirements and do not need to be modified.\n\u003C/p>\n\u003Cdiv class=\"quotationbox\">\n  \u003Cdiv class=\"boxtitle\">\n    \u003Cp>‘Placing on the market’\u003C/p>\n  \u003C/div>\n  \u003Cdiv class=\"boxsource\">\n    \u003Cp>\u003Ca href=\"#ref-mdr\">MDR\u003C/a>, Article 2(28)\u003C/p>\n  \u003C/div>\n  \u003Cp>\n    means the first making available of a device, other than an investigational device, on the Union\n    market.\n  \u003C/p>\n\u003C/div>\n\u003Cp>\n  \u003Cstrong>2.1(a)\u003C/strong> Consumer general‑purpose computer hardware systems and operating systems\n  for those hardware systems (\u003Cmark class=\"hl hl-red\">UNLIKELY\u003C/mark>)\n\u003C/p>\n\u003Cp>\n  Due to their specialized functions, medical devices are inherently purpose-built rather than\n  general-purpose. As such, the definition of a\n  \u003Cem>consumer general purpose computer hardware system\u003C/em> under the \u003Ca href=\"#ref-eaa\">EAA\u003C/a> is\n  generally not applicable to medical device:\n\u003C/p>\n\u003Cdiv class=\"quotationbox\">\n  \u003Cdiv class=\"boxtitle\">\n    \u003Cp>‘Consumer \u003Cmark class=\"hl hl-yellow\">general purpose\u003C/mark> computer hardware system’\u003C/p>\n  \u003C/div>\n  \u003Cdiv class=\"boxsource\">\n    \u003Cp>\u003Ca href=\"#ref-eaa\">EAA\u003C/a>, Article 3(39)\u003C/p>\n  \u003C/div>\n  \u003Cp>\n    means the combination of hardware which forms a complete computer, characterised by its\n    multipurpose nature, its ability to perform, with the appropriate software, most common\n    computing tasks requested by consumers and intended to be operated by consumers, including\n    personal computers, in particular desktops, notebooks, smartphones and tablets;\n  \u003C/p>\n\u003C/div>\n\u003Cp>\u003Cstrong>2.1(b)\u003C/strong> The following self-service terminals:\u003C/p>\n\u003Ch5 id=\"bi-payment-terminals-hl-redunlikelyhl\">\n  2.1(b)(i) Payment terminals (\u003Cmark class=\"hl hl-red\">UNLIKELY\u003C/mark>)\n\u003C/h5>\n\u003Cp>\n  It is theoretically conceivable that a device could fulfill the definition of a medical device\n  under the MDR while having as its primary purpose the facilitation of payments. However, it is\n  difficult to identify any such device currently available on the market.\n\u003C/p>\n\u003Cdiv class=\"quotationbox\">\n  \u003Cdiv class=\"boxtitle\">\n    \u003Cp>‘Payment terminal’\u003C/p>\n  \u003C/div>\n  \u003Cdiv class=\"boxsource\">\n    \u003Cp>\u003Ca href=\"#ref-eaa\">EAA\u003C/a>, Article 3(29)\u003C/p>\n  \u003C/div>\n  \u003Cp>\n    means a device \u003Cmark class=\"hl hl-yellow\">the main purpose of which\u003C/mark> is to allow payments\n    to be made by using payment instruments as defined in point 14 of Article 4 of Directive (EU)\n    2015/2366 at a physical point of sale but not in a virtual environment;\n  \u003C/p>\n\u003C/div>\n\u003Ch5\n  id=\"bii-the-following-self-service-terminals-dedicated-to-the-provision-of-services-covered-by-this-directive-hl-redunlikelyhl\"\n>\n  2.1(b)(ii) The following self-service terminals dedicated to the provision of services covered by\n  this Directive: (\u003Cmark class=\"hl hl-red\">UNLIKELY\u003C/mark>)\n\u003C/h5>\n\u003Cp>\n  In principle, an assistive technology could allow clinically disabled patients as a self-service\n  terminal—such as an automated teller machine or an interactive terminal providing information.\n  However, for a device to fall under the scope of Article 2.1b(ii), it is not sufficient for it to\n  simply belong to one of the four listed categories:\n\u003C/p>\n\u003Cul>\n  \u003Cli>\u003Cp>automated teller machines,\u003C/p>\u003C/li>\n  \u003Cli>\u003Cp>ticketing machines,\u003C/p>\u003C/li>\n  \u003Cli>\u003Cp>check-in machines,\u003C/p>\u003C/li>\n  \u003Cli>\n    \u003Cp>\n      or interactive self-service terminals providing information, excluding those integrated into\n      vehicles, aircraft, ships, or rolling stock.\n    \u003C/p>\n  \u003C/li>\n\u003C/ul>\n\u003Cp>\n  The article also requires that the services provided by the device fall within the scope of\n  services covered by the \u003Ca href=\"#ref-eaa\">EAA\u003C/a>. These services are enumerated in Article 2.2\n  and will be analyzed in the following sections. As we will see, it is overall unlikely that many\n  medical devices will meet the service-related criteria required under this provision.\n\u003C/p>\n\u003Cp>\n  \u003Cstrong>2.1(c)\u003C/strong> Consumer terminal equipment with interactive computing capability, used\n  for electronic communications services (\u003Cmark class=\"hl hl-orange\">RARE\u003C/mark>)\n  \u003Cspan id=\"subsec-electronic-communication-systems\">\u003C/span>\n\u003C/p>\n\u003Cp>\n  The \u003Ca href=\"#ref-eaa\">EAA\u003C/a> does not explicitly define this category of devices. However, in\n  the context of \u003Cem>electronic communications services\u003C/em>, Recitals 28, 29, and 45 of the\n  \u003Ca href=\"#ref-eaa\">EAA\u003C/a> refer to the definitions provided in the \u003Ca href=\"#ref-eecc\">EECC\u003C/a>:\n\u003C/p>\n\u003Cdiv class=\"quotationbox\">\n  \u003Cdiv class=\"boxtitle\">\n    \u003Cp>‘Electronic communications services’\u003C/p>\n  \u003C/div>\n  \u003Cdiv class=\"boxsource\">\n    \u003Cp>\u003Ca href=\"#ref-eecc\">EECC\u003C/a>, Article 2(4)\u003C/p>\n  \u003C/div>\n  \u003Cp>\n    means a service normally provided for remuneration via electronic communications networks, which\n    encompasses, with the exception of services providing, or exercising editorial control over,\n    content transmitted using electronic communications networks and services, the following types\n    of services:\n  \u003C/p>\n  \u003Col>\n    \u003Cli>\n      \u003Cp>\n        ‘internet access service’ as defined in point (2) of the second paragraph of Article 2 of\n        Regulation (EU) 2015/2120;\n      \u003C/p>\n    \u003C/li>\n    \u003Cli>\u003Cp>interpersonal communications service; and\u003C/p>\u003C/li>\n    \u003Cli>\n      \u003Cp>\n        services consisting wholly or mainly in the conveyance of signals such as transmission\n        services used for the provision of machine-to-machine services and for broadcasting;\n      \u003C/p>\n    \u003C/li>\n  \u003C/ol>\n\u003C/div>\n\u003Cp>\n  In this context, \u003Cem>internet access service\u003C/em> refers to access to the entire internet\n  \u003Ca href=\"#ref-netneutralityreg\">Net Neutrality Regulation (Regulation (EU) 2015/2120)\u003C/a>. For\n  example, an assistive technology that enables patients to access the internet may fall within the\n  scope of this device group.\n\u003C/p>\n\u003Cp>\n  Some medical devices do incorporate communication capabilities. However, it is important to note\n  that the definition of \u003Cem>interpersonal communications service\u003C/em> in the\n  \u003Ca href=\"#ref-eecc\">EECC\u003C/a> is narrowly framed. Specifically, two conditions must be met: first,\n  the user must be able to determine the recipients of the communication; and second, the\n  communication functionality must constitute a principal feature of the device:\n\u003C/p>\n\u003Cdiv class=\"quotationbox\">\n  \u003Cdiv class=\"boxtitle\">\n    \u003Cp>‘Interpersonal communications service’\u003C/p>\n  \u003C/div>\n  \u003Cdiv class=\"boxsource\">\n    \u003Cp>\u003Ca href=\"#ref-eecc\">EECC\u003C/a>, Article 2(5)\u003C/p>\n  \u003C/div>\n  \u003Cp>\n    means a service normally provided for remuneration that enables direct interpersonal and\n    interactive exchange of information via electronic communications networks between a finite\n    number of persons, whereby\n    \u003Cmark class=\"hl hl-yellow\"\n      >the persons initiating or participating in the communication determine its recipient(s)\u003C/mark\n    >\n    and does not include services which enable interpersonal and interactive communication\n    \u003Cmark class=\"hl hl-yellow\">merely as a minor ancillary feature\u003C/mark> that is intrinsically\n    linked to another service;\n  \u003C/p>\n\u003C/div>\n\u003Cp>\n  \u003Cstrong>2.1d\u003C/strong> consumer terminal equipment with interactive computing capability, used for\n  accessing audiovisual media services (\u003Cmark class=\"hl hl-orange\">RARE\u003C/mark>)\n  \u003Cspan id=\"subsec-audiovisual-medial-services\">\u003C/span>\n\u003C/p>\n\u003Cp>\n  Unlike for Article 2.1c, the \u003Ca href=\"#ref-eaa\">EAA\u003C/a> provides a specific definition of this\n  article subpoint:\n\u003C/p>\n\u003Cdiv class=\"quotationbox\">\n  \u003Cdiv class=\"boxtitle\">\n    \u003Cp>\n      ‘consumer terminal equipment with interactive computing capability, used for accessing\n      audiovisual media services’\n    \u003C/p>\n  \u003C/div>\n  \u003Cdiv class=\"boxsource\">\n    \u003Cp>\u003Ca href=\"#ref-eaa\">EAA\u003C/a>, Article 3(7)\u003C/p>\n  \u003C/div>\n  \u003Cp>\n    means any equipment \u003Cmark class=\"hl hl-yellow\">the main purpose of which\u003C/mark> is to provide\n    access to audiovisual media services;\n  \u003C/p>\n\u003C/div>\n\u003Cp>\n  This wording emphasizes that the primary purpose of the device must be to deliver audiovisual\n  content. To understand what qualifies as an audiovisual media service, we must refer to the\n  definition provided in the \u003Ca href=\"#ref-avmsd\">AVMSD\u003C/a> (\u003Ca href=\"#ref-eaa\">EAA\u003C/a>, Recital\n  31):\n\u003C/p>\n\u003Cdiv class=\"quotationbox\">\n  \u003Cdiv class=\"boxtitle\">\n    \u003Cp>‘Audiovisual media service’\u003C/p>\n  \u003C/div>\n  \u003Cdiv class=\"boxsource\">\n    \u003Cp>\u003Ca href=\"#ref-avmsd\">AVMSD\u003C/a>, Article 1.1(a)\u003C/p>\n  \u003C/div>\n  \u003Cp>means\u003C/p>\n  \u003Col>\n    \u003Cli>\n      \u003Cp>\n        a service as defined by Articles 56 and 57 of the Treaty on the Functioning of the European\n        Union which is under the editorial responsibility of a media service provider and\n        \u003Cmark class=\"hl hl-yellow\">the principal purpose of which\u003C/mark> is the provision of\n        programmes, in order to inform, entertain or educate, to\n        \u003Cmark class=\"hl hl-yellow\">the general public\u003C/mark> by electronic communications networks\n        within the meaning of point (a) of Article 2 of Directive 2002/21/EC. Such an audiovisual\n        media service is either a television broadcast as defined in point (e) of this paragraph or\n        an on-demand audiovisual media service as defined in point (g) of this paragraph;\n      \u003C/p>\n    \u003C/li>\n    \u003Cli>\u003Cp>audiovisual commercial communication;\u003C/p>\u003C/li>\n  \u003C/ol>\n\u003C/div>\n\u003Cp>Here, audiovisual commercial communication is further defined as:\u003C/p>\n\u003Cdiv class=\"quotationbox\">\n  \u003Cdiv class=\"boxtitle\">\n    \u003Cp>‘Audiovisual commercial communication’\u003C/p>\n  \u003C/div>\n  \u003Cdiv class=\"boxsource\">\n    \u003Cp>\u003Ca href=\"#ref-avmsd\">AVMSD\u003C/a>, Article 1.1(h)\u003C/p>\n  \u003C/div>\n  \u003Cp>\n    means images with or without sound which are designed to promote, directly or indirectly, the\n    goods, services or image of a natural or legal entity pursuing an economic activity. Such images\n    accompany or are included in a programme in return for payment or for similar consideration or\n    for self-promotional purposes. Forms of audiovisual commercial communication include, inter\n    alia, television advertising, sponsorship, teleshopping and product placement;\n  \u003C/p>\n\u003C/div>\n\u003Cp>\n  On this basis, a medical device that delivers educational content—such as medical training\n  materials—targeted at patients or their carers—could, in theory, fall under this category,\n  provided that its \u003Cem>primary purpose\u003C/em> is the provision of audiovisual media services and the\n  medical purpose is the ancillary one.\n\u003C/p>\n\u003Cp>\u003Cstrong>2.1(e)\u003C/strong> E-readers (\u003Cmark class=\"hl hl-orange\">RARE\u003C/mark>)\u003C/p>\n\u003Cp>The \u003Ca href=\"#ref-eaa\">EAA\u003C/a> defines an \u003Cem>e-reader\u003C/em> as:\u003C/p>\n\u003Cdiv class=\"quotationbox\">\n  \u003Cdiv class=\"boxtitle\">\n    \u003Cp>‘e-reader’\u003C/p>\n  \u003C/div>\n  \u003Cdiv class=\"boxsource\">\n    \u003Cp>\u003Ca href=\"#ref-eaa\">EAA\u003C/a>, Article 3(42)\u003C/p>\n  \u003C/div>\n  \u003Cp>\n    means dedicated equipment, including both hardware and software, used to access, navigate, read\n    and use \u003Cmark class=\"hl hl-yellow\">e-book files\u003C/mark>;\n  \u003C/p>\n\u003C/div>\n\u003Cp>\n  In order for a device to be considered an e-reader under the \u003Ca href=\"#ref-eaa\">EAA\u003C/a>, it is not\n  sufficient for it to merely display digital information. The device must specifically be intended\n  to display \u003Cem>e-book files\u003C/em>. While the directive does not provide a formal definition of\n  \u003Cem>e-book file\u003C/em>, Recital 42 offers context:\n\u003C/p>\n\u003Cdiv class=\"quotationbox\">\n  \u003Cdiv class=\"boxsource\">\n    \u003Cp>\u003Ca href=\"#ref-eaa\">EAA\u003C/a>, Recital 42\u003C/p>\n  \u003C/div>\n  \u003Cp>\n    E-book files are based on an electronic computer coding that enables the circulation and\n    consultation of a mostly textual and graphical intellectual work. […]\n  \u003C/p>\n\u003C/div>\n\u003Cp>\n  This suggests that an \u003Cem>e-book file\u003C/em> is not just any digital document but a structured\n  digital publication resembling traditional books, typically intended for reading by the general\n  public.\n\u003C/p>\n\u003Cp>\n  Therefore, a medical device or system used to display patient-specific data, such as electronic\n  health records, would not be considered an e-reader under the \u003Ca href=\"#ref-eaa\">EAA\u003C/a>. However,\n  if a device is specifically intended to access and read standard e-book content, then it may fall\n  under the scope of the \u003Ca href=\"#ref-eaa\">EAA\u003C/a> as an e-reader.\n\u003C/p>\n\u003Cp>\n  \u003Cstrong>2.2\u003C/strong> Without prejudice to Article 32, this Directive applies to the following\n  services provided to consumers after 28 June 2025:\n\u003C/p>\n\u003Cp>\n  The second part of \u003Ca href=\"#ref-eaa\">EAA\u003C/a> Article 2 outlines the services that fall within the\n  scope of the Directive. These include a range of digital and transport-related services—such as\n  electronic communications, e-commerce platforms, banking, e-books, and passenger transport—which\n  must meet the accessibility requirements when offered to consumers from 28 June 2025 onward.\n\u003C/p>\n\u003Cp>\n  For services, the concept of \u003Cem>placing on the market\u003C/em> is less clearly defined than it is for\n  physical products. Therefore, \u003Ca href=\"#ref-eaa\">EAA\u003C/a> Article 32 provides transitional\n  provisions that allow services already in use before 28 June 2025 to continue operating without\n  immediate need for compliance.\n\u003C/p>\n\u003Cp>\n  \u003Cstrong>2.2(a)\u003C/strong> electronic communications services with the exception of transmission\n  services used for the provision of machine-to- machine services; (\u003Cmark class=\"hl hl-orange\"\n    >RARE\u003C/mark\n  >)\n\u003C/p>\n\u003Cp>The same considerations apply as those outlined for the scope of Article 2.1(c).\u003C/p>\n\u003Cp>\n  \u003Cstrong>2.2(b)\u003C/strong> services providing access to audiovisual media services; (\u003Cmark\n    class=\"hl hl-orange\"\n    >RARE\u003C/mark\n  >)\n\u003C/p>\n\u003Cp>The same considerations apply as those outlined for the scope of Article 2.1(d).\u003C/p>\n\u003Cp>\n  \u003Cstrong>2.2(c)\u003C/strong> the following elements of air, bus, rail and waterborne passenger\n  transport services, except for urban, suburban and regional transport services for which only the\n  elements under point (v) apply: (\u003Cmark class=\"hl hl-red\">UNLIKELY\u003C/mark>)\n\u003C/p>\n\u003Cp>\n  While it is not impossible that medical devices could one day be integrated into passenger\n  transport services, particularly in accessibility-related contexts, it is currently difficult to\n  identify any medical device that would fall under this provision.\n\u003C/p>\n\u003Cp>\u003Cstrong>2.2(d)\u003C/strong> consumer banking services (\u003Cmark class=\"hl hl-red\">UNLIKELY\u003C/mark>)\u003C/p>\n\u003Cp>\n  It is unlikely that any currently marketed medical device falls under the\n  \u003Ca href=\"#ref-eaa\">EAA\u003C/a> definition of \u003Cem>consumer banking services\u003C/em>:\n\u003C/p>\n\u003Cdiv class=\"quotationbox\">\n  \u003Cdiv class=\"boxtitle\">\n    \u003Cp>‘Consumer banking services’\u003C/p>\n  \u003C/div>\n  \u003Cdiv class=\"boxsource\">\n    \u003Cp>\u003Ca href=\"#ref-eaa\">EAA\u003C/a>, Article 3(28)\u003C/p>\n  \u003C/div>\n  \u003Cp>means the provision to consumers of the following banking and financial services:\u003C/p>\n  \u003Col>\n    \u003Cli>\n      \u003Cp>\n        credit agreements covered by Directive 2008/48/EC of the European Parliament and of the\n        Council or Directive 2014/17/EU of the European Parliament and of the Council;\n      \u003C/p>\n    \u003C/li>\n    \u003Cli>\n      \u003Cp>\n        services as defined in points 1, 2, 4 and 5 in Section A and points 1, 2, 4 and 5 in Section\n        B of Annex I to Directive 2014/65/EU of the European Parliament and of the Council;\n      \u003C/p>\n    \u003C/li>\n    \u003Cli>\n      \u003Cp>\n        payment services as defined in point 3 of Article 4 of Directive (EU) 2015/2366 of the\n        European Parliament and of the Council;\n      \u003C/p>\n    \u003C/li>\n    \u003Cli>\n      \u003Cp>\n        services linked to the payment account as defined in point 6 of Article 2 of Directive\n        2014/92/EU of the European Parliament and of the Council;\n      \u003C/p>\n    \u003C/li>\n    \u003Cli>\u003Cp>electronic money as defined under relevant EU legislation.\u003C/p>\u003C/li>\n  \u003C/ol>\n\u003C/div>\n\u003Cp>\n  \u003Cstrong>2.2(e)\u003C/strong> e-books and dedicated software; and (\u003Cmark class=\"hl hl-orange\">RARE\u003C/mark\n  >)\n\u003C/p>\n\u003Cp>\n  This topic is closely related to Article 2.1(e), which concerns consumer terminal equipment for\n  accessing audiovisual media services. Therefore, similar considerations apply. However, it is\n  important to note that the \u003Ca href=\"#ref-eaa\">EAA\u003C/a> provides a specific definition for the term\n  \u003Cem>e-books and dedicated software\u003C/em>:\n\u003C/p>\n\u003Cdiv class=\"quotationbox\">\n  \u003Cdiv class=\"boxtitle\">\n    \u003Cp>‘e-book and dedicated software’\u003C/p>\n  \u003C/div>\n  \u003Cdiv class=\"boxsource\">\n    \u003Cp>\u003Ca href=\"#ref-eaa\">EAA\u003C/a>, Article 3(41)\u003C/p>\n  \u003C/div>\n  \u003Cp>\n    means a service, consisting of the provision of digital files that convey an electronic version\n    \u003Cmark class=\"hl hl-yellow\">of a book\u003C/mark>, that can be accessed, navigated, read and used and\n    the software including mobile device-based services including mobile applications dedicated to\n    the accessing, navigation, reading and use of those digital files, and it excludes software\n    covered under the definition in point (42);\n  \u003C/p>\n\u003C/div>\n\u003Cp>\u003Cstrong>2.2(f)\u003C/strong> e-commerce services; (\u003Cmark class=\"hl hl-orange\">RARE\u003C/mark>)\u003C/p>\n\u003Cp>The \u003Ca href=\"#ref-eaa\">EAA\u003C/a> defines\u003C/p>\n\u003Cdiv class=\"quotationbox\">\n  \u003Cdiv class=\"boxtitle\">\n    \u003Cp>‘e-commerce services’\u003C/p>\n  \u003C/div>\n  \u003Cdiv class=\"boxsource\">\n    \u003Cp>\u003Ca href=\"#ref-eaa\">EAA\u003C/a>, Article 3(30)\u003C/p>\n  \u003C/div>\n  \u003Cp>\n    means services provided at a distance, through websites and mobile device-based services by\n    electronic means and at the individual request of a consumer with a view to concluding a\n    consumer contract;\n  \u003C/p>\n\u003C/div>\n\u003Cp>\n  A medical device that incorporates features such as in-app purchases or enables direct consumer\n  transactions through digital platforms could, in theory, fall under this point. However, current\n  medtech distribution models rarely rely on such e-commerce mechanisms.\n\u003C/p>\n\u003Cp>\n  \u003Cstrong>2.3\u003C/strong> This Directive applies to answering emergency communications to the single\n  European emergency number ‘112’. (\u003Cmark class=\"hl hl-orange\">RARE\u003C/mark>)\n\u003C/p>\n\u003Cp>\n  Medical devices falling under this point would be subject to the requirements of the\n  \u003Ca href=\"#ref-eaa\">EAA\u003C/a>. At present, such devices appear to be rare. However, this could change\n  with the rapid advancement of AI technologies.\n\u003C/p>\n\u003Ch2 class=\"unnumbered\" id=\"references\">References\u003C/h2>\n\u003Cul>\n  \u003Cli>\n    \u003Cdiv id=\"ref-accessibleeu\">\u003C/div>\n    \u003Cp>\n      \u003Cstrong>AccessibleEU Report\u003C/strong> — AccessibleEU Report: Accessibility Legislation at\n      European Level. European Commission, 2023\n    \u003C/p>\n  \u003C/li>\n  \u003Cli>\n    \u003Cdiv id=\"ref-avmsd\">\u003C/div>\n    \u003Cp>\n      \u003Cstrong>AVMSD\u003C/strong> — Directive 2010/13/EU on the coordination of certain provisions laid\n      down by law, regulation or administrative action in Member States concerning the provision of\n      audiovisual media services (Audiovisual Media Services Directive). European Parliament and\n      Council of the European Union, 2010\n    \u003C/p>\n  \u003C/li>\n  \u003Cli>\n    \u003Cdiv id=\"ref-eaa\">\u003C/div>\n    \u003Cp>\n      \u003Cstrong>EAA\u003C/strong> — Directive (EU) 2019/882 on the accessibility requirements for products\n      and services. European Parliament and Council of the European Union, 2019\n    \u003C/p>\n  \u003C/li>\n  \u003Cli>\n    \u003Cdiv id=\"ref-eecc\">\u003C/div>\n    \u003Cp>\n      \u003Cstrong>EECC\u003C/strong> — Directive (EU) 2018/1972 establishing the European Electronic\n      Communications Code (Recast). European Parliament and Council of the European Union, 2018\n    \u003C/p>\n  \u003C/li>\n  \u003Cli>\n    \u003Cdiv id=\"ref-mdd\">\u003C/div>\n    \u003Cp>\n      \u003Cstrong>MDD\u003C/strong> — Council Directive 93/42/EEC of 14 June 1993 concerning medical devices\n      (MDD). Council of the European Communities, 1993\n    \u003C/p>\n  \u003C/li>\n  \u003Cli>\n    \u003Cdiv id=\"ref-mdr\">\u003C/div>\n    \u003Cp>\n      \u003Cstrong>MDR\u003C/strong> — Regulation (EU) 2017/745 on medical devices. European Parliament and\n      Council of the European Union, 2024\n    \u003C/p>\n  \u003C/li>\n  \u003Cli>\n    \u003Cdiv id=\"ref-netneutralityreg\">\u003C/div>\n    \u003Cp>\n      \u003Cstrong>Net Neutrality Regulation (Regulation (EU) 2015/2120)\u003C/strong> — Regulation (EU)\n      2015/2120 laying down measures concerning open internet access and retail charges for\n      regulated intra-EU communications. European Parliament and Council of the European Union, 2015\n    \u003C/p>\n  \u003C/li>\n\u003C/ul>\n",1792608381978]