[{"data":1,"prerenderedAt":4},["ShallowReactive",2],{"guide-intended-purpose":3},"\u003Ch2 id=\"introduction\">1 Introduction\u003C/h2>\n\u003Cp>\n  \u003Ca href=\"#ref-mdr\">MDR\u003C/a> Article 2.12 defines “intended purpose” as: “\u003Cem\n    >the use for which a device is intended\u003C/em\n  >”. That statement is quite circular for a definition. While the remainder of Article 2.12\n  emphasizes the need of consistency between information material, clinical data and intended\n  purpose, it still does not provide much help when it comes to building an intended purpose for\n  CE-certification. However, there is no reason to despair.\n\u003C/p>\n\u003Cp>First, you probably have more experience with intended purposes than you think.\u003C/p>\n\u003Cp>\n  The pharmaceutical industry has been drafting intended uses for decades. When you buy a medicine,\n  you will find a pamphlet explaining what the medication is for, who should take it, when to take\n  it, and so on. This is the intended use of the medication. While there are differences between the\n  intended uses of medicinal products and those of medical devices, reviewing this information can\n  give you an idea (and also inspiration) of what an intended purpose might look like.\n\u003C/p>\n\u003Cp>\n  Furthermore, in this paper, we provide a clear methodology for defining the intended purpose of\n  medical devices, along with examples and best practices.\n\u003C/p>\n\u003Cp>Before we dive into the methodology, let’s answer a few we are frequently asked.\u003C/p>\n\u003Cdiv class=\"boxbox\">\n  \u003Cdiv class=\"boxtitle\">\n    \u003Cp>Frequently Asked Questions\u003C/p>\n  \u003C/div>\n  \u003Cp>\n    \u003Cstrong>\u003Cspan style=\"color: blue\">When should I create the intended purpose?\u003C/span>\u003C/strong>\n  \u003C/p>\n  \u003Cp>\n    You can think of the intended purpose as the underpinning on which the entire technical\n    documentation of your device is built. Therefore, you should create the intended purpose as the\n    very first piece of information in your technical file. Ideally, you should have a first version\n    of the intended purpose before starting any development, verification, or validation activity.\n    Do not expect to get the intended purpose perfect on the first try; you will probably need\n    several rounds of refinement.\n  \u003C/p>\n  \u003Cp>\n    \u003Cstrong\n      >\u003Cspan style=\"color: blue\"\n        >Is there a difference between “intended purpose” and “intended use”?\u003C/span\n      >\u003C/strong\n    >\n  \u003C/p>\n  \u003Cp>\n    The \u003Ca href=\"#ref-mdr\">MDR\u003C/a> defines “\u003Cem>intended purpose\u003C/em>” and mentions it 83 times.\n    However, the \u003Ca href=\"#ref-mdr\">MDR\u003C/a> does not define “\u003Cem>intended use\u003C/em>” even though it\n    mentions it 16 times. “\u003Cem>Intended use\u003C/em>” is a terminology that stems from the pharma and\n    from non-European certification systems, including the FDA. IMDRF is aware of the different\n    terminologies and in \u003Ca href=\"#ref-imdrf-n9\">IMDRF WG/N9\u003C/a> attempts to make a subtle\n    distinction between the two expressions. However, in \u003Ca href=\"#ref-imdrf-n47\">IMDRF WG/N47\u003C/a>,\n    IMDRF treats the two terms as equivalent alternatives. In the CE-certification praxis, you can\n    consider the two terms to have the same meaning. This is also the position of\n    \u003Ca href=\"#ref-mdcg-2020-6\">MDCG 2020-6\u003C/a>.\n  \u003C/p>\n  \u003Cp>\n    \u003Cstrong\n      >\u003Cspan style=\"color: blue\">Where can I find good examples of intended purpose?\u003C/span>\u003C/strong\n    >\n  \u003C/p>\n  \u003Cp>\n    When creating your intended purpose, you don’t have to start from scratch. There are plenty of\n    resources available to help you draft it.\n  \u003C/p>\n  \u003Cp>\n    We suggest looking at the nomenclature provided by the\n    \u003Ca href=\"https://www.gmdnagency.org\">GMDN Agency\u003C/a>. While the GMDN definitions do not\n    necessarily cover all the information you need in your intended purpose, they often provide a\n    good starting point. Another interesting source is the\n    \u003Ca href=\"https://medevis.who-healthtechnologies.org/\">MeDevIs\u003C/a> website from WHO.\n  \u003C/p>\n  \u003Cp>\n    \u003Cstrong\n      >\u003Cspan style=\"color: blue\"\n        >How should I structure the intended purpose information?\u003C/span\n      >\u003C/strong\n    >\n  \u003C/p>\n  \u003Cp>\n    How you structure the intended purpose information is entirely up to you. You may present it as\n    a single paragraph, divide it into separate sections, or even organize it in a table. The key\n    requirement is that the information is clear and easily understandable.\n  \u003C/p>\n\u003C/div>\n\u003Ch2 id=\"the-structure-of-the-intended-purpose\">2 The structure of the intended purpose\u003C/h2>\n\u003Cp>\n  The \u003Ca href=\"#ref-mdr\">MDR\u003C/a> does not explicitely specify a structure of the intended purpose.\n  However, the MDCG points to the section of the \u003Ca href=\"#ref-mdr\">MDR\u003C/a> that they consider a\n  specification of the content of intended purpose. Specifically,\n  \u003Ca href=\"#ref-mdcg-2022-9\">MDCG 2022-9\u003C/a> points to \u003Ca href=\"#ref-mdr\">MDR\u003C/a> Annex II, Part\n  1.1(c) as the requirements on the content of the intended purpose. This content includes “\u003Cem\n    >the intended patient population and medical conditions to be diagnosed, treated and/or\n    monitored and other considerations such as patient selection criteria, indications,\n    contraindications, warnings\u003C/em\n  >”. We can find confirmation of the MDCG approach in another part of the\n  \u003Ca href=\"#ref-mdr\">MDR\u003C/a>, specifically Annex I, Part 23.4(b). This\n  \u003Ca href=\"#ref-mdr\">MDR\u003C/a> section specifies that the IFU should include“\u003Cem\n    >the device’s intended purpose with a clear specification of indications, contra-indications,\n    the patient target group or groups, and of the intended users, as appropriate.\u003C/em\n  >” This structure is reminiscent of that specified in Annex II, Part 1.1(c). All-in-all, both\n  \u003Ca href=\"#ref-mdr\">MDR\u003C/a> sections, highlight a similar structure, as follows:\n\u003C/p>\n\u003Col>\n  \u003Cli>\u003Cp>Indication(s)\u003C/p>\u003C/li>\n  \u003Cli>\u003Cp>Target population(s)\u003C/p>\u003C/li>\n  \u003Cli>\u003Cp>Contraindications and warnings\u003C/p>\u003C/li>\n  \u003Cli>\u003Cp>Intended user(s)\u003C/p>\u003C/li>\n\u003C/ol>\n\u003Cp>\n  In this document, we propose a slightly modified structure for the intended purpose with two\n  additional points:\n\u003C/p>\n\u003Col>\n  \u003Cli>\u003Cp>Generic device group\u003C/p>\u003C/li>\n  \u003Cli>\u003Cp>Indication(s)\u003C/p>\u003C/li>\n  \u003Cli>\u003Cp>Target population(s)\u003C/p>\u003C/li>\n  \u003Cli>\u003Cp>Contraindications and warnings\u003C/p>\u003C/li>\n  \u003Cli>\u003Cp>Intended user(s)\u003C/p>\u003C/li>\n  \u003Cli>\u003Cp>Relevant safety and performance information\u003C/p>\u003C/li>\n\u003C/ol>\n\u003Cp>In the remaining of the document, we will analyze each element separately.\u003C/p>\n\u003Ch2 id=\"generic-device-group\">3 Generic device group\u003C/h2>\n\u003Cp>\n  \u003Ca href=\"#ref-mdr\">MDR\u003C/a> Article 2.7 defines generic device group “\u003Cem\n    >a set of devices having the same or similar intended purposes or a commonality of technology\n    allowing them to be classified in a generic manner not reflecting specific characteristics\u003C/em\n  >”. The regulation does not explicitly require the inclusion of the device group in the intended\n  purpose. However, if the medical literature specifies standardized nomenclature to describe your\n  device group, it is useful to provide this information at the start of the intended purpose.\n\u003C/p>\n\u003Cp>\n  Consider an example. Devices that use UVA or UVB light to treat skin conditions are commonly\n  referred to in the medical literature as “phototherapy devices”. Using this terminology ensures\n  that users immediately understand the type of device being described. The intended purpose of such\n  a device can thus begin with this information:\n\u003C/p>\n\u003Cdiv class=\"examplebox\">\n  \u003Cdiv class=\"boxtitle\">\n    \u003Cp>\n      Example: Phototherapy device \u003Cspan class=\"legend hl-green\" aria-hidden=\"true\">\u003C/span> =\n      generic device group\n    \u003C/p>\n  \u003C/div>\n  \u003Cp>\n    A \u003Cmark class=\"hl hl-green\">phototherapy device\u003C/mark> that emits UVB and UVA radiation for the\n    treatment of psoriasis […]\n  \u003C/p>\n\u003C/div>\n\u003Ch2 id=\"indications\">4 Indication(s)\u003C/h2>\n\u003Cp>We can categorize device indications into two types:\u003C/p>\n\u003Cul>\n  \u003Cli>\u003Cp>Condition-based indications\u003C/p>\u003C/li>\n  \u003Cli>\u003Cp>Procedure-based indications\u003C/p>\u003C/li>\n\u003C/ul>\n\u003Cp>The following sections provide a detailed analysis of each indication type.\u003C/p>\n\u003Ch3 id=\"condition-based-indications\">4.1 Condition-based indications\u003C/h3>\n\u003Cp>\n  \u003Ca href=\"#ref-mdr\">MDR\u003C/a> Article 2.1 clarifies the medical purposes—such as prevention of\n  disease, treatment of a disability, etc.—covered by the regulation. These purposes are summarized\n  in Table \u003Ca href=\"#mdr-purposes\">1\u003C/a>. A large number of medical devices achieve their medical\n  purposes for a defined set of conditions. Here we use the term \"condition\", which is not\n  explicitly defined in regulatory guidance but is widely used in medicine to describe a broad\n  category of health issues, including diseases, injuries, and disabilities, pathological processes,\n  etc. For these devices, the indication can be specified using their medical purpose. Let’s\n  consider some examples.\n\u003C/p>\n\u003Cdiv class=\"table-wrap\">\n  \u003Ctable>\n    \u003Ccaption>\n      Table 1: Medical purposes defined in MDR Article 2.1, definition of \"medical device\" provided\n      in (•= combination applicable,\n      \u003Cspan class=\"math inline\">∘\u003C/span>\n      = combination not applicable). The combinations in orange are provided in MDR Annex VIII.\n      Monitoring of physiological processes is not specified as a medical purpose in Article 2.1.\n      However, MDR Annex VIII extends the are of application of \"monitoring\" to phsyiological\n      conditions, state of health, illnesses or congenital deformities, physiological processes,\n      vital physiological processes and vital parameters.\n    \u003C/caption>\n    \u003Ctbody>\n      \u003Ctr class=\"odd\">\n        \u003Ctd style=\"text-align: left\">\u003C/td>\n        \u003Ctd style=\"text-align: left\">Disease\u003C/td>\n        \u003Ctd style=\"text-align: left\">Injury\u003C/td>\n        \u003Ctd style=\"text-align: left\">Disability\u003C/td>\n        \u003Ctd style=\"text-align: left\">Anatomy\u003C/td>\n        \u003Ctd style=\"text-align: left\">Physiological process/state\u003C/td>\n        \u003Ctd style=\"text-align: left\">Pathological process/state\u003C/td>\n      \u003C/tr>\n      \u003Ctr class=\"even\">\n        \u003Ctd style=\"text-align: left\">\u003Cstrong>Diagnostic/treatment purposes\u003C/strong>\u003C/td>\n        \u003Ctd style=\"text-align: left\">\u003C/td>\n        \u003Ctd style=\"text-align: left\">\u003C/td>\n        \u003Ctd style=\"text-align: left\">\u003C/td>\n        \u003Ctd style=\"text-align: left\">\u003C/td>\n        \u003Ctd style=\"text-align: left\">\u003C/td>\n        \u003Ctd style=\"text-align: left\">\u003C/td>\n      \u003C/tr>\n      \u003Ctr class=\"odd\">\n        \u003Ctd style=\"text-align: left\">Prevention\u003C/td>\n        \u003Ctd style=\"text-align: left\" class=\"cell-lightgreen\">•\u003C/td>\n        \u003Ctd style=\"text-align: left\" class=\"cell-lightgray\">\u003Cspan class=\"math inline\">∘\u003C/span>\u003C/td>\n        \u003Ctd style=\"text-align: left\" class=\"cell-lightgray\">\u003Cspan class=\"math inline\">∘\u003C/span>\u003C/td>\n        \u003Ctd style=\"text-align: left\" class=\"cell-lightgray\">\u003Cspan class=\"math inline\">∘\u003C/span>\u003C/td>\n        \u003Ctd style=\"text-align: left\" class=\"cell-lightgray\">\u003Cspan class=\"math inline\">∘\u003C/span>\u003C/td>\n        \u003Ctd style=\"text-align: left\" class=\"cell-lightgray\">\u003Cspan class=\"math inline\">∘\u003C/span>\u003C/td>\n      \u003C/tr>\n      \u003Ctr class=\"even\">\n        \u003Ctd style=\"text-align: left\">Prediction\u003C/td>\n        \u003Ctd style=\"text-align: left\" class=\"cell-lightgreen\">•\u003C/td>\n        \u003Ctd style=\"text-align: left\" class=\"cell-lightgray\">\u003Cspan class=\"math inline\">∘\u003C/span>\u003C/td>\n        \u003Ctd style=\"text-align: left\" class=\"cell-lightgray\">\u003Cspan class=\"math inline\">∘\u003C/span>\u003C/td>\n        \u003Ctd style=\"text-align: left\" class=\"cell-lightgray\">\u003Cspan class=\"math inline\">∘\u003C/span>\u003C/td>\n        \u003Ctd style=\"text-align: left\" class=\"cell-lightgray\">\u003Cspan class=\"math inline\">∘\u003C/span>\u003C/td>\n        \u003Ctd style=\"text-align: left\" class=\"cell-lightgray\">\u003Cspan class=\"math inline\">∘\u003C/span>\u003C/td>\n      \u003C/tr>\n      \u003Ctr class=\"odd\">\n        \u003Ctd style=\"text-align: left\">Prognosis\u003C/td>\n        \u003Ctd style=\"text-align: left\" class=\"cell-lightgreen\">•\u003C/td>\n        \u003Ctd style=\"text-align: left\" class=\"cell-lightgray\">\u003Cspan class=\"math inline\">∘\u003C/span>\u003C/td>\n        \u003Ctd style=\"text-align: left\" class=\"cell-lightgray\">\u003Cspan class=\"math inline\">∘\u003C/span>\u003C/td>\n        \u003Ctd style=\"text-align: left\" class=\"cell-lightgray\">\u003Cspan class=\"math inline\">∘\u003C/span>\u003C/td>\n        \u003Ctd style=\"text-align: left\" class=\"cell-lightgray\">\u003Cspan class=\"math inline\">∘\u003C/span>\u003C/td>\n        \u003Ctd style=\"text-align: left\" class=\"cell-lightgray\">\u003Cspan class=\"math inline\">∘\u003C/span>\u003C/td>\n      \u003C/tr>\n      \u003Ctr class=\"even\">\n        \u003Ctd style=\"text-align: left\">Diagnosis\u003C/td>\n        \u003Ctd style=\"text-align: left\" class=\"cell-lightgreen\">•\u003C/td>\n        \u003Ctd style=\"text-align: left\" class=\"cell-lightgreen\">•\u003C/td>\n        \u003Ctd style=\"text-align: left\" class=\"cell-lightgreen\">•\u003C/td>\n        \u003Ctd style=\"text-align: left\" class=\"cell-lightgray\">\u003Cspan class=\"math inline\">∘\u003C/span>\u003C/td>\n        \u003Ctd style=\"text-align: left\" class=\"cell-lightgray\">\u003Cspan class=\"math inline\">∘\u003C/span>\u003C/td>\n        \u003Ctd style=\"text-align: left\" class=\"cell-lightgray\">\u003Cspan class=\"math inline\">∘\u003C/span>\u003C/td>\n      \u003C/tr>\n      \u003Ctr class=\"odd\">\n        \u003Ctd style=\"text-align: left\">Treatment\u003C/td>\n        \u003Ctd style=\"text-align: left\" class=\"cell-lightgreen\">•\u003C/td>\n        \u003Ctd style=\"text-align: left\" class=\"cell-lightgreen\">•\u003C/td>\n        \u003Ctd style=\"text-align: left\" class=\"cell-lightgreen\">•\u003C/td>\n        \u003Ctd style=\"text-align: left\" class=\"cell-lightgray\">\u003Cspan class=\"math inline\">∘\u003C/span>\u003C/td>\n        \u003Ctd style=\"text-align: left\" class=\"cell-lightgray\">\u003Cspan class=\"math inline\">∘\u003C/span>\u003C/td>\n        \u003Ctd style=\"text-align: left\" class=\"cell-lightgray\">\u003Cspan class=\"math inline\">∘\u003C/span>\u003C/td>\n      \u003C/tr>\n      \u003Ctr class=\"even\">\n        \u003Ctd style=\"text-align: left\">Alleviation\u003C/td>\n        \u003Ctd style=\"text-align: left\" class=\"cell-lightgreen\">•\u003C/td>\n        \u003Ctd style=\"text-align: left\" class=\"cell-lightgreen\">•\u003C/td>\n        \u003Ctd style=\"text-align: left\" class=\"cell-lightgreen\">•\u003C/td>\n        \u003Ctd style=\"text-align: left\" class=\"cell-lightgray\">\u003Cspan class=\"math inline\">∘\u003C/span>\u003C/td>\n        \u003Ctd style=\"text-align: left\" class=\"cell-lightgray\">\u003Cspan class=\"math inline\">∘\u003C/span>\u003C/td>\n        \u003Ctd style=\"text-align: left\" class=\"cell-lightgray\">\u003Cspan class=\"math inline\">∘\u003C/span>\u003C/td>\n      \u003C/tr>\n      \u003Ctr class=\"odd\">\n        \u003Ctd style=\"text-align: left\">Monitoring\u003C/td>\n        \u003Ctd style=\"text-align: left\" class=\"cell-lightgreen\">•\u003C/td>\n        \u003Ctd style=\"text-align: left\" class=\"cell-lightgreen\">•\u003C/td>\n        \u003Ctd style=\"text-align: left\" class=\"cell-lightgreen\">•\u003C/td>\n        \u003Ctd style=\"text-align: left\" class=\"cell-lightgray\">\u003Cspan class=\"math inline\">∘\u003C/span>\u003C/td>\n        \u003Ctd style=\"text-align: left\" class=\"cell-lightorange\">•\u003C/td>\n        \u003Ctd style=\"text-align: left\" class=\"cell-lightorange\">•\u003C/td>\n      \u003C/tr>\n      \u003Ctr class=\"even\">\n        \u003Ctd style=\"text-align: left\">Compensation\u003C/td>\n        \u003Ctd style=\"text-align: left\" class=\"cell-lightgray\">\u003Cspan class=\"math inline\">∘\u003C/span>\u003C/td>\n        \u003Ctd style=\"text-align: left\" class=\"cell-lightgreen\">•\u003C/td>\n        \u003Ctd style=\"text-align: left\" class=\"cell-lightgreen\">•\u003C/td>\n        \u003Ctd style=\"text-align: left\" class=\"cell-lightgray\">\u003Cspan class=\"math inline\">∘\u003C/span>\u003C/td>\n        \u003Ctd style=\"text-align: left\" class=\"cell-lightgray\">\u003Cspan class=\"math inline\">∘\u003C/span>\u003C/td>\n        \u003Ctd style=\"text-align: left\" class=\"cell-lightgray\">\u003Cspan class=\"math inline\">∘\u003C/span>\u003C/td>\n      \u003C/tr>\n      \u003Ctr class=\"odd\">\n        \u003Ctd style=\"text-align: left\">Investigation\u003C/td>\n        \u003Ctd style=\"text-align: left\" class=\"cell-lightgray\">\u003Cspan class=\"math inline\">∘\u003C/span>\u003C/td>\n        \u003Ctd style=\"text-align: left\" class=\"cell-lightgray\">\u003Cspan class=\"math inline\">∘\u003C/span>\u003C/td>\n        \u003Ctd style=\"text-align: left\" class=\"cell-lightgray\">\u003Cspan class=\"math inline\">∘\u003C/span>\u003C/td>\n        \u003Ctd style=\"text-align: left\" class=\"cell-lightgreen\">•\u003C/td>\n        \u003Ctd style=\"text-align: left\" class=\"cell-lightgreen\">•\u003C/td>\n        \u003Ctd style=\"text-align: left\" class=\"cell-lightgreen\">•\u003C/td>\n      \u003C/tr>\n      \u003Ctr class=\"even\">\n        \u003Ctd style=\"text-align: left\">Replacement\u003C/td>\n        \u003Ctd style=\"text-align: left\" class=\"cell-lightgray\">\u003Cspan class=\"math inline\">∘\u003C/span>\u003C/td>\n        \u003Ctd style=\"text-align: left\" class=\"cell-lightgray\">\u003Cspan class=\"math inline\">∘\u003C/span>\u003C/td>\n        \u003Ctd style=\"text-align: left\" class=\"cell-lightgray\">\u003Cspan class=\"math inline\">∘\u003C/span>\u003C/td>\n        \u003Ctd style=\"text-align: left\" class=\"cell-lightgreen\">•\u003C/td>\n        \u003Ctd style=\"text-align: left\" class=\"cell-lightgreen\">•\u003C/td>\n        \u003Ctd style=\"text-align: left\" class=\"cell-lightgreen\">•\u003C/td>\n      \u003C/tr>\n      \u003Ctr class=\"odd\">\n        \u003Ctd style=\"text-align: left\">Modification\u003C/td>\n        \u003Ctd style=\"text-align: left\" class=\"cell-lightgray\">\u003Cspan class=\"math inline\">∘\u003C/span>\u003C/td>\n        \u003Ctd style=\"text-align: left\" class=\"cell-lightgray\">\u003Cspan class=\"math inline\">∘\u003C/span>\u003C/td>\n        \u003Ctd style=\"text-align: left\" class=\"cell-lightgray\">\u003Cspan class=\"math inline\">∘\u003C/span>\u003C/td>\n        \u003Ctd style=\"text-align: left\" class=\"cell-lightgreen\">•\u003C/td>\n        \u003Ctd style=\"text-align: left\" class=\"cell-lightgreen\">•\u003C/td>\n        \u003Ctd style=\"text-align: left\" class=\"cell-lightgreen\">•\u003C/td>\n      \u003C/tr>\n      \u003Ctr class=\"even\">\n        \u003Ctd style=\"text-align: left\">\u003Cstrong>Other purposes\u003C/strong>\u003C/td>\n        \u003Ctd style=\"text-align: left\">\u003C/td>\n        \u003Ctd style=\"text-align: left\">\u003C/td>\n        \u003Ctd style=\"text-align: left\">\u003C/td>\n        \u003Ctd style=\"text-align: left\">\u003C/td>\n        \u003Ctd style=\"text-align: left\">\u003C/td>\n        \u003Ctd style=\"text-align: left\">\u003C/td>\n      \u003C/tr>\n      \u003Ctr class=\"odd\">\n        \u003Ctd style=\"text-align: left\">Control of conception\u003C/td>\n        \u003Ctd style=\"text-align: left\">\u003C/td>\n        \u003Ctd style=\"text-align: left\">\u003C/td>\n        \u003Ctd style=\"text-align: left\">\u003C/td>\n        \u003Ctd style=\"text-align: left\">\u003C/td>\n        \u003Ctd style=\"text-align: left\">\u003C/td>\n        \u003Ctd style=\"text-align: left\">\u003C/td>\n      \u003C/tr>\n      \u003Ctr class=\"even\">\n        \u003Ctd style=\"text-align: left\">Support of conception\u003C/td>\n        \u003Ctd style=\"text-align: left\">\u003C/td>\n        \u003Ctd style=\"text-align: left\">\u003C/td>\n        \u003Ctd style=\"text-align: left\">\u003C/td>\n        \u003Ctd style=\"text-align: left\">\u003C/td>\n        \u003Ctd style=\"text-align: left\">\u003C/td>\n        \u003Ctd style=\"text-align: left\">\u003C/td>\n      \u003C/tr>\n      \u003Ctr class=\"odd\">\n        \u003Ctd style=\"text-align: left\">Cleaning of devices\u003C/td>\n        \u003Ctd style=\"text-align: left\">\u003C/td>\n        \u003Ctd style=\"text-align: left\">\u003C/td>\n        \u003Ctd style=\"text-align: left\">\u003C/td>\n        \u003Ctd style=\"text-align: left\">\u003C/td>\n        \u003Ctd style=\"text-align: left\">\u003C/td>\n        \u003Ctd style=\"text-align: left\">\u003C/td>\n      \u003C/tr>\n      \u003Ctr class=\"even\">\n        \u003Ctd style=\"text-align: left\">Disinfection of devices\u003C/td>\n        \u003Ctd style=\"text-align: left\">\u003C/td>\n        \u003Ctd style=\"text-align: left\">\u003C/td>\n        \u003Ctd style=\"text-align: left\">\u003C/td>\n        \u003Ctd style=\"text-align: left\">\u003C/td>\n        \u003Ctd style=\"text-align: left\">\u003C/td>\n        \u003Ctd style=\"text-align: left\">\u003C/td>\n      \u003C/tr>\n      \u003Ctr class=\"odd\">\n        \u003Ctd style=\"text-align: left\">Sterilization of devices\u003C/td>\n        \u003Ctd style=\"text-align: left\">\u003C/td>\n        \u003Ctd style=\"text-align: left\">\u003C/td>\n        \u003Ctd style=\"text-align: left\">\u003C/td>\n        \u003Ctd style=\"text-align: left\">\u003C/td>\n        \u003Ctd style=\"text-align: left\">\u003C/td>\n        \u003Ctd style=\"text-align: left\">\u003C/td>\n      \u003C/tr>\n    \u003C/tbody>\n  \u003C/table>\n\u003C/div>\n\u003Cdiv id=\"mdr-purposes\">\u003C/div>\n\u003Cp>\n  Phototherapy devices are used to treat dermatological disorders, such as psoriasis. For diseases,\n  the permitted purposes include treatment, alleviation, diagnosis, prevention, monitoring,\n  prediction, and prognosis. Phototherapy devices are typically used for treatment. The indication\n  of a phototherapy device, therefore, is to treat psoriasis. Here a possible formulation of\n  intended purpose for such a device:\n\u003C/p>\n\u003Cdiv class=\"examplebox\">\n  \u003Cdiv class=\"boxtitle\">\n    \u003Cp>\n      Example: Phototherapy device ( \u003Cspan class=\"legend hl-yellow\" aria-hidden=\"true\">\u003C/span> =\n      indication )\n    \u003C/p>\n  \u003C/div>\n  \u003Cp>\n    A phototherapy device that emits UVB and UVA radiation for the\n    \u003Cmark class=\"hl hl-yellow\">treatment of psoriasis\u003C/mark> […]\n  \u003C/p>\n\u003C/div>\n\u003Cp>Hearing aids are an example of device for compensation of a disability\u003C/p>\n\u003Cdiv class=\"examplebox\">\n  \u003Cdiv class=\"boxtitle\">\n    \u003Cp>\n      Example: Bone-conduction hearing aid (\n      \u003Cspan class=\"legend hl-yellow\" aria-hidden=\"true\">\u003C/span> = indication )\n    \u003C/p>\n  \u003C/div>\n  \u003Cp>\n    An electrically-powered, external, acoustic device intended to\n    \u003Cmark class=\"hl hl-yellow\">compensate for impaired hearing\u003C/mark> […]\n  \u003C/p>\n\u003C/div>\n\u003Cp>A limb prosthesis serves as a replacement for a missing or impaired part of the anatomy.\u003C/p>\n\u003Cdiv class=\"examplebox\">\n  \u003Cdiv class=\"boxtitle\">\n    \u003Cp>\n      Example: Hand prosthesis ( \u003Cspan class=\"legend hl-yellow\" aria-hidden=\"true\">\u003C/span> =\n      indication )\n    \u003C/p>\n  \u003C/div>\n  \u003Cp>\n    A hand prosthesis designed to\n    \u003Cmark class=\"hl hl-yellow\">replace the appearance of the hand\u003C/mark> […]\n  \u003C/p>\n\u003C/div>\n\u003Cp>\n  Devices that are medical device software or that include medical device software (see\n  \u003Ca href=\"#ref-mdcg-2019-11\">MDCG 2019-11\u003C/a> for a definition of medical device software) might\n  achieve their intended purpose indirectly by providing information to the user. In such cases, it\n  is important to emphasize this in the intended purpose. This is done by using the formulation from\n  the first part of \u003Ca href=\"#ref-mdr\">MDR\u003C/a> Annex VIII, Part 6.3 (Rule 11): “\u003Cem\n    >provide information which is used to take decisions\u003C/em\n  >”. For example:\n\u003C/p>\n\u003Cdiv class=\"examplebox\">\n  \u003Cdiv class=\"boxtitle\">\n    \u003Cp>\n      Example: Lung-cancer detection AI system (\n      \u003Cspan class=\"legend hl-yellow\" aria-hidden=\"true\">\u003C/span> = indication )\n    \u003C/p>\n  \u003C/div>\n  \u003Cp>\n    A software AI system intended to\n    \u003Cmark class=\"hl hl-yellow\"\n      >provide information which is used for the diagnosis lung cancer\u003C/mark\n    >\n    […]\n  \u003C/p>\n\u003C/div>\n\u003Cp>\n  A device can have several indications simultaneously. For example, the same device could treat a\n  condition or help preventing it:\n\u003C/p>\n\u003Cdiv class=\"examplebox\">\n  \u003Cdiv class=\"boxtitle\">\n    \u003Cp>\n      Example: Continuous passive motion (\n      \u003Cspan class=\"legend hl-yellow\" aria-hidden=\"true\">\u003C/span> = indication )\n    \u003C/p>\n  \u003C/div>\n  \u003Cp>\n    A continuous passive motion device intended to \u003Cmark class=\"hl hl-yellow\">prevent\u003C/mark> and\n    \u003Cmark class=\"hl hl-yellow\">treat joint stiffness\u003C/mark> […]\n  \u003C/p>\n\u003C/div>\n\u003Cp>\n  These two indications (treatment and prevention) identify two different intended purposes of the\n  device. It is important to be aware of the distinction since the two intended purposed might\n  require separate considerations for certification (risk management, clinical validation,\n  post-market surveillance, etc.).\n\u003C/p>\n\u003Cdiv class=\"warningbox\">\n  \u003Cdiv class=\"boxtitle\" id=\"box-1\">\u003Cp>Box 1: Indications, target population, and claims\u003C/p>\u003C/div>\n  \u003Cdiv class=\"center\">\n    \u003Cp>\u003Cimg src=\"/guides/intended-purpose/drawing-1.svg\" alt=\"image\" />\u003C/p>\n  \u003C/div>\n  \u003Cp>\n    The condition specified in a condition-based indication is not necessarily the clinical picture\n    of the target populations of the device (see Section \u003Ca href=\"#sec-target\">5\u003C/a>). For example,\n    devices with prediagnostic clinical pictures (see Section \u003Ca href=\"#sec-prediagnostic\">2\u003C/a>)\n    target patients with symptoms, signs, and risk factors that suggest the presence of a condition.\n  \u003C/p>\n  \u003Cp>\n    Similarly, indications and claims\u003Ca\n      href=\"#fn1\"\n      class=\"footnote-ref\"\n      id=\"fnref1\"\n      role=\"doc-noteref\"\n      >\u003Csup>1\u003C/sup>\u003C/a\n    >\n    can be very different. For example, the manufacturer of the AI system in the example above might\n    claim that the device improves the efficiency of healthcare professionals without affecting the\n    sensitivity or specificity of the diagnosis. However, the indication for the software device\n    remains \"provide information used for diagnosis,\" whereas the performance claim would be \"reduce\n    time required by the healthcare professional for diagnosis.\"\n  \u003C/p>\n\u003C/div>\n\u003Ch3 id=\"procedure-based-indications\">4.2 Procedure-based indications\u003C/h3>\n\u003Cp>\n  Whenever a condition-based indication is possible, it should be the preferred approach. However,\n  some devices do not have condition-based indications because their medical purpose is not directed\n  at specific conditions (such as diseases, injuries, or disabilities). Instead, these devices are\n  intended to assist, enable, or perform a medical procedure, regardless of the underlying\n  condition. Many routine, day-to-day medical devices are procedure-based, such as thermometers,\n  intravenous cannulas, or surgical scalpels\n\u003C/p>\n\u003Cdiv class=\"examplebox\">\n  \u003Cdiv class=\"boxtitle\">\n    \u003Cp>\n      Example: Capillary patient thermometer, mercury (\n      \u003Cspan class=\"legend hl-yellow\" aria-hidden=\"true\">\u003C/span> = indication )\n    \u003C/p>\n  \u003C/div>\n  \u003Cp>\n    An instrument designed\n    \u003Cmark class=\"hl hl-yellow\">to measure a patient’s body temperature\u003C/mark> […]\n  \u003C/p>\n\u003C/div>\n\u003Cdiv class=\"examplebox\">\n  \u003Cdiv class=\"boxtitle\">\n    \u003Cp>\n      Example: Peripheral intravenous cannula (\n      \u003Cspan class=\"legend hl-yellow\" aria-hidden=\"true\">\u003C/span> = indication )\n    \u003C/p>\n  \u003C/div>\n  \u003Cp>\n    A short, thin tube intended to be inserted into a peripheral vein (typically on the hand/arm) to\n    enable short-term (< 30 days) intravenous (IV) access\n    \u003Cmark class=\"hl hl-yellow\">for administration of fluids/medication and blood sampling\u003C/mark> […]\n  \u003C/p>\n\u003C/div>\n\u003Cp>\n  However, there are also more complex procedure-based devices, such as cell savers, which are used\n  in surgical settings to recover and reinfuse a patient’s own blood, reducing the need for donor\n  transfusions.\n\u003C/p>\n\u003Cdiv class=\"examplebox\">\n  \u003Cdiv class=\"boxtitle\">\n    \u003Cp>\n      Example: Autotransfusion system ( \u003Cspan class=\"legend hl-yellow\" aria-hidden=\"true\">\u003C/span> =\n      indication )\n    \u003C/p>\n  \u003C/div>\n  \u003Cp>\n    An assembly of devices that includes an electrically-powered aspiration (suction) pump intended\n    to be used\n    \u003Cmark class=\"hl hl-yellow\"\n      >to collect, filter, and reinfuse intraoperative and/or postoperative autologous blood shed\n      during and/or after surgery\u003C/mark\n    >\n    […]\n  \u003C/p>\n\u003C/div>\n\u003Cp>\n  The fact that a device is procedure-based rather than condition-based does not mean it lacks a\n  target population or that its target population (see Section \u003Ca href=\"#sec-target\">5\u003C/a>) cannot\n  include a clinical picture. For example, an autotransfusion system is intended for adult patients\n  experiencing blood loss exceeding 500ṁl (or more than 10% of their calculated total blood volume)\n  and for children weighing over 10 kg with a blood loss greater than 8 ml/kg (or more than 10% of\n  their calculated total blood volume).\n\u003C/p>\n\u003Ch3 id=\"devices-without-a-medical-purpose\">4.3 Devices without a medical purpose\u003C/h3>\n\u003Cp>\n  The \u003Ca href=\"#ref-mdr\">MDR\u003C/a> covers devices that do not have a medical purpose, the Annex XVI\n  devices. These devices require nonetheless an intended purpose. Notice that the\n  \u003Ca href=\"#ref-mdr\">MDR\u003C/a> readily provides the purposes for most of the classes listed in Annex\n  XVI, these are:\n\u003C/p>\n\u003Cul>\n  \u003Cli>\u003Cp>modifying the anatomy or fixation of body parts […]\u003C/p>\u003C/li>\n  \u003Cli>\u003Cp>filling of facial or other dermal or mucous membrane […]\u003C/p>\u003C/li>\n  \u003Cli>\u003Cp>reduce, remove or destroy adipose tissue […]\u003C/p>\u003C/li>\n  \u003Cli>\u003Cp>skin resurfacing, tattoo or hair removal or other skin treatment […]\u003C/p>\u003C/li>\n  \u003Cli>\u003Cp>brain stimulation […]\u003C/p>\u003C/li>\n\u003C/ul>\n\u003Ch2 id=\"target-populations\">5 Target population(s)\u003C/h2>\n\u003Cdiv id=\"sec-target\">\u003C/div>\n\u003Cp>\n  While it is conceivable to design medical devices without a user (think of a futuristic, fully\n  automated medical system), a medical device cannot exist without a target population. Therefore,\n  after specifying the device indication, the next step is to define the population profile. For\n  those familiar with clinical studies, this part of the intended purpose can be likened to the\n  inclusion criteria of the CIP. There are two aspects of the target population that need\n  specification:\n\u003C/p>\n\u003Col>\n  \u003Cli>\u003Cp>The demongraphics\u003C/p>\u003C/li>\n  \u003Cli>\u003Cp>The clinical picture\u003C/p>\u003C/li>\n\u003C/ol>\n\u003Cp>Below we consider both aspects in detail.\u003C/p>\n\u003Ch3 id=\"demographics\">5.1 Demographics\u003C/h3>\n\u003Cp>\n  Demographics can include information such as patient age class (neonates, children, adults,\n  elderly, etc.), gender, weight, height, race, ethnicity, nationality, skin type, marital status,\n  socioeconomic status (e.g., occupation, employment status, income level, education level, housing\n  status, access to healthcared, social support networks, access to transportation, household size\n  and composition, neighborhood characteristics, debt level, etc), cultural background, lifestyle\n  factors (e.g., smoking, alchohol consumption, physical activity), and many more that can affect\n  the ability of a device to achieve its intended performance and safety.\n\u003C/p>\n\u003Cp>\n  For example, a phototherapy device might be restricted to use in adult patients only. Furthermore,\n  due to its construction, the device might only accomodate patients up to a certain height. This\n  information should be included in the intended purpose demographics specifications:\n\u003C/p>\n\u003Cdiv class=\"examplebox\">\n  \u003Cdiv class=\"boxtitle\">\n    \u003Cp>\n      Example: Phototherapy device ( \u003Cspan class=\"legend hl-lilac\" aria-hidden=\"true\">\u003C/span> =\n      Demographics )\n    \u003C/p>\n  \u003C/div>\n  \u003Cp>\n    A phototherapy device emits UVB and UVA radiation for the treatment of psoriasis in\n    \u003Cmark class=\"hl hl-lilac\">adult patients (maximum height 190 cm)\u003C/mark> with moderate to severe\n    psoriasis […]\n  \u003C/p>\n\u003C/div>\n\u003Cdiv class=\"warningbox\">\n  \u003Cdiv class=\"boxtitle\" id=\"box-2\">\u003Cp>Box 2: Vulnerable populations\u003C/p>\u003C/div>\n  \u003Cp>\n    Notified bodies will pay particular attention to whether the device’s target patient population\n    includes “vulnerable populations” such as neonates, infants, children, adolescents, disabled\n    individuals, geriatric patients, lactating or pregnant women, etc. If your device addresses one\n    of these populations, you must state it clearly in your intended purpose.\n  \u003C/p>\n\u003C/div>\n\u003Ch3 id=\"clinical-picture\">5.2 Clinical picture\u003C/h3>\n\u003Cp>\n  The clinical picture specifies the medical conditions, symptoms, or diseases of the target\n  population. There is often confusion regarding the difference between the conditions (disease,\n  injury, disability, processes) specified in the indication and the clinical picture of the target\n  population.\n\u003C/p>\n\u003Cp>We can consider analyze three cases:\u003C/p>\n\u003Cul>\n  \u003Cli>\u003Cp>The target population does not include a clinical picture;\u003C/p>\u003C/li>\n  \u003Cli>\u003Cp>The clinical picture is prediagnostic;\u003C/p>\u003C/li>\n  \u003Cli>\u003Cp>The clinical picture is postdiagnostic.\u003C/p>\u003C/li>\n\u003C/ul>\n\u003Cp>\n  Table \u003Ca href=\"#purposes-vs-indication\">2\u003C/a> summarizes which scenarios are applicable for which\n  indication. Below we analyze each scenario separately.\n\u003C/p>\n\u003Cdiv class=\"table-wrap\">\n  \u003Ctable>\n    \u003Ccaption>\n      Table 2: Relationship between medical purposes and clinical picture in the target population\n      (• = combination applicable,\n      \u003Cspan class=\"math inline\">∘\u003C/span>\n      = combination not applicable).\n    \u003C/caption>\n    \u003Ctbody>\n      \u003Ctr class=\"odd\">\n        \u003Ctd style=\"text-align: left\">\u003C/td>\n        \u003Ctd style=\"text-align: left\">Healthy subjects\u003C/td>\n        \u003Ctd style=\"text-align: left\">Prediagnosis clinical picture\u003C/td>\n        \u003Ctd style=\"text-align: left\">Postdiagnosis clinical picture\u003C/td>\n      \u003C/tr>\n      \u003Ctr class=\"even\">\n        \u003Ctd style=\"text-align: left\">Diagnosis\u003C/td>\n        \u003Ctd style=\"text-align: left\" class=\"cell-lightgray\">\u003Cspan class=\"math inline\">∘\u003C/span>\u003C/td>\n        \u003Ctd style=\"text-align: left\" class=\"cell-lightgreen\">•\u003C/td>\n        \u003Ctd style=\"text-align: left\" class=\"cell-lightgray\">\u003Cspan class=\"math inline\">∘\u003C/span>\u003C/td>\n      \u003C/tr>\n      \u003Ctr class=\"odd\">\n        \u003Ctd style=\"text-align: left\">Prevention\u003C/td>\n        \u003Ctd style=\"text-align: left\" class=\"cell-lightgreen\">•\u003C/td>\n        \u003Ctd style=\"text-align: left\" class=\"cell-lightgreen\">•\u003C/td>\n        \u003Ctd style=\"text-align: left\" class=\"cell-lightgray\">\u003Cspan class=\"math inline\">∘\u003C/span>\u003C/td>\n      \u003C/tr>\n      \u003Ctr class=\"even\">\n        \u003Ctd style=\"text-align: left\">Prediction\u003C/td>\n        \u003Ctd style=\"text-align: left\" class=\"cell-lightgreen\">•\u003C/td>\n        \u003Ctd style=\"text-align: left\" class=\"cell-lightgreen\">•\u003C/td>\n        \u003Ctd style=\"text-align: left\" class=\"cell-lightgray\">\u003Cspan class=\"math inline\">∘\u003C/span>\u003C/td>\n      \u003C/tr>\n      \u003Ctr class=\"odd\">\n        \u003Ctd style=\"text-align: left\">Prognosis\u003C/td>\n        \u003Ctd style=\"text-align: left\" class=\"cell-lightgray\">\u003Cspan class=\"math inline\">∘\u003C/span>\u003C/td>\n        \u003Ctd style=\"text-align: left\" class=\"cell-lightgray\">\u003Cspan class=\"math inline\">∘\u003C/span>\u003C/td>\n        \u003Ctd style=\"text-align: left\" class=\"cell-lightgreen\">•\u003C/td>\n      \u003C/tr>\n      \u003Ctr class=\"even\">\n        \u003Ctd style=\"text-align: left\">Monitoring\u003C/td>\n        \u003Ctd style=\"text-align: left\" class=\"cell-lightgray\">\u003Cspan class=\"math inline\">∘\u003C/span>\u003C/td>\n        \u003Ctd style=\"text-align: left\" class=\"cell-lightorange\">•\u003C/td>\n        \u003Ctd style=\"text-align: left\" class=\"cell-lightgreen\">•\u003C/td>\n      \u003C/tr>\n      \u003Ctr class=\"odd\">\n        \u003Ctd style=\"text-align: left\">Investigation\u003C/td>\n        \u003Ctd style=\"text-align: left\" class=\"cell-lightgreen\">•\u003C/td>\n        \u003Ctd style=\"text-align: left\" class=\"cell-lightgreen\">•\u003C/td>\n        \u003Ctd style=\"text-align: left\" class=\"cell-lightgreen\">•\u003C/td>\n      \u003C/tr>\n      \u003Ctr class=\"even\">\n        \u003Ctd style=\"text-align: left\">Treatment\u003C/td>\n        \u003Ctd style=\"text-align: left\" class=\"cell-lightgray\">\u003Cspan class=\"math inline\">∘\u003C/span>\u003C/td>\n        \u003Ctd style=\"text-align: left\" class=\"cell-lightgray\">\u003Cspan class=\"math inline\">∘\u003C/span>\u003C/td>\n        \u003Ctd style=\"text-align: left\" class=\"cell-lightgreen\">•\u003C/td>\n      \u003C/tr>\n      \u003Ctr class=\"odd\">\n        \u003Ctd style=\"text-align: left\">Alleviation\u003C/td>\n        \u003Ctd style=\"text-align: left\" class=\"cell-lightgray\">\u003Cspan class=\"math inline\">∘\u003C/span>\u003C/td>\n        \u003Ctd style=\"text-align: left\" class=\"cell-lightgray\">\u003Cspan class=\"math inline\">∘\u003C/span>\u003C/td>\n        \u003Ctd style=\"text-align: left\" class=\"cell-lightgreen\">•\u003C/td>\n      \u003C/tr>\n      \u003Ctr class=\"even\">\n        \u003Ctd style=\"text-align: left\">Compensation\u003C/td>\n        \u003Ctd style=\"text-align: left\" class=\"cell-lightgray\">\u003Cspan class=\"math inline\">∘\u003C/span>\u003C/td>\n        \u003Ctd style=\"text-align: left\" class=\"cell-lightgray\">\u003Cspan class=\"math inline\">∘\u003C/span>\u003C/td>\n        \u003Ctd style=\"text-align: left\" class=\"cell-lightgreen\">•\u003C/td>\n      \u003C/tr>\n      \u003Ctr class=\"odd\">\n        \u003Ctd style=\"text-align: left\">Replacement\u003C/td>\n        \u003Ctd style=\"text-align: left\" class=\"cell-lightgray\">\u003Cspan class=\"math inline\">∘\u003C/span>\u003C/td>\n        \u003Ctd style=\"text-align: left\" class=\"cell-lightgray\">\u003Cspan class=\"math inline\">∘\u003C/span>\u003C/td>\n        \u003Ctd style=\"text-align: left\" class=\"cell-lightgreen\">•\u003C/td>\n      \u003C/tr>\n      \u003Ctr class=\"even\">\n        \u003Ctd style=\"text-align: left\">Modification\u003C/td>\n        \u003Ctd style=\"text-align: left\" class=\"cell-lightgreen\">•\u003C/td>\n        \u003Ctd style=\"text-align: left\" class=\"cell-lightgray\">\u003Cspan class=\"math inline\">∘\u003C/span>\u003C/td>\n        \u003Ctd style=\"text-align: left\" class=\"cell-lightgreen\">•\u003C/td>\n      \u003C/tr>\n    \u003C/tbody>\n  \u003C/table>\n\u003C/div>\n\u003Cdiv id=\"purposes-vs-indication\">\u003C/div>\n\u003Ch4 id=\"the-target-population-does-not-include-a-clinical-picture\">\n  The target population does not include a clinical picture\n\u003C/h4>\n\u003Cp>\n  While all target population specifications include demographic details, not all include a clinical\n  picture. This is because some devices are not intended for a specific medical condition. For\n  example, a thermometer is designed for temperature measurement and can be used on any individual,\n  regardless of their clinical status. However, the target population may still specify whether the\n  thermometer is intended for adults, children, or both based on factors such as usability,\n  accuracy, or safety considerations.\n\u003C/p>\n\u003Cp>\n  Devices can also target subjects who have not received any diagnosis nor are manifesting symptoms.\n  This can be, for example, the case with devices for prevention. For example:\n\u003C/p>\n\u003Cdiv class=\"examplebox\">\n  \u003Cdiv class=\"boxtitle\">\n    \u003Cp>\n      Example: Lice prevention solution (\n      \u003Cspan class=\"legend hl-yellow\" aria-hidden=\"true\">\u003C/span> = indication )\n    \u003C/p>\n  \u003C/div>\n  \u003Cp>\n    A liquid substance intended to be applied topically to the scalp and head hair to\n    \u003Cmark class=\"hl hl-yellow\">prevent infestation of human head lice\u003C/mark> (Pediculus humanus\n    capitis) […]\n  \u003C/p>\n\u003C/div>\n\u003Cp>\n  In this example, the substance is applied before the infestation. The same can occurr with devices\n  for prediction. For example:\n\u003C/p>\n\u003Cdiv class=\"examplebox\">\n  \u003Cdiv class=\"boxtitle\">\n    \u003Cp>\n      Example: Framingham Risk Score ( \u003Cspan class=\"legend hl-yellow\" aria-hidden=\"true\">\u003C/span> =\n      indication )\n    \u003C/p>\n  \u003C/div>\n  \u003Cp>\n    A software device indicated for the\n    \u003Cmark class=\"hl hl-yellow\">prediction of coronary heart disease\u003C/mark> […]\n  \u003C/p>\n\u003C/div>\n\u003Cp>\n  Such prediction tools are commonly used in screening programs targeting asymptomatic individuals.\n  However, not all devices targeting healthy patients are solely focused on future outcomes. For\n  example, investigational devices can also serve healthy individuals but for immediate assessments.\n  For example:\n\u003C/p>\n\u003Cdiv class=\"examplebox\">\n  \u003Cdiv class=\"boxtitle\">\n    \u003Cp>\n      Example: Pelvimeter ( \u003Cspan class=\"legend hl-yellow\" aria-hidden=\"true\">\u003C/span> = indication )\n    \u003C/p>\n  \u003C/div>\n  \u003Cp>\n    A measuring device used to \u003Cmark class=\"hl hl-yellow\">determine the pelvic dimensions\u003C/mark> […]\n  \u003C/p>\n\u003C/div>\n\u003Cp>\n  Indeed, a pelvimeter helps healthcare providers determine whether the pelvic dimensions are\n  adequate for a vaginal delivery or if there might be complications that would necessitate a\n  Cesarean section. Alternatively, the anatomy could be modified for esthetic reasons:\n\u003C/p>\n\u003Cdiv class=\"examplebox\">\n  \u003Cdiv class=\"boxtitle\">\n    \u003Cp>\n      Example: Breast implant ( \u003Cspan class=\"legend hl-yellow\" aria-hidden=\"true\">\u003C/span> =\n      indication )\n    \u003C/p>\n  \u003C/div>\n  \u003Cp>\n    A sterile implantable device designed to\n    \u003Cmark class=\"hl hl-yellow\">augment the breast\u003C/mark> […]\n  \u003C/p>\n\u003C/div>\n\u003Ch4 id=\"the-clinical-picture-is-prediagnostic\">The clinical picture is prediagnostic\u003C/h4>\n\u003Cdiv id=\"sec-prediagnostic\">\u003C/div>\n\u003Cp>\n  Devices intended for diagnosis are used with patients for whom the disease, injury, disability, or\n  condition to be diagnosed has not yet manifested nor has been diagnosed. This means that for\n  devices with diagnostic purposes, the clinical picture is prediagnostic: it cannot include the\n  specific disease, injury, or disability in question. Instead, the clinical picture must list the\n  symptoms, signs, and factors that may potentially lead to these conditions. For example:\n\u003C/p>\n\u003Cdiv class=\"examplebox\">\n  \u003Cdiv class=\"boxtitle\">\n    \u003Cp>\n      Example: Polysomnogram ( \u003Cspan class=\"legend hl-yellow\" aria-hidden=\"true\">\u003C/span> =\n      indication; \u003Cspan class=\"legend hl-cyan\" aria-hidden=\"true\">\u003C/span> = clinical picture )\n    \u003C/p>\n  \u003C/div>\n  \u003Cp>\n    A polysomnogram that can be used or at home or in-hospital for\n    \u003Cmark class=\"hl hl-yellow\">diagnosing of sleep apnea\u003C/mark>. It is indicated for patients with\n    symptoms such as\n    \u003Cmark class=\"hl hl-cyan\"\n      >loud snoring, gasping for air during sleep, awakening with a dry mouth, morning headache,\n      difficulty staying asleep, daytime sleepiness, irritability\u003C/mark\n    >\n    […]\n  \u003C/p>\n\u003C/div>\n\u003Cp>\n  The device is used to detect irregular breathing patterns during sleep that might indicate sleep\n  apnea. Therefore, at the time the device is used, the patient cannot have a diagnosed sleep apnea\n  condition yet. The clinical picture specifies sleep apnea’s symptoms or risk factors (snoring,\n  daytime sleepiness, etc.).\n\u003C/p>\n\u003Cp>\n  Prediagnostic clinical pictures are not an exclusive of diagnostic devices but can also be the\n  target of devices for prevention, prediction, monitoring and investigation. Let’s consider some\n  examples:\n\u003C/p>\n\u003Cdiv class=\"examplebox\">\n  \u003Cdiv class=\"boxtitle\">\n    \u003Cp>\n      Example: CHA\u003Csub>2\u003C/sub>DS\u003Csub>2\u003C/sub>-VASc score calculator (\n      \u003Cspan class=\"legend hl-yellow\" aria-hidden=\"true\">\u003C/span> = indication;\n      \u003Cspan class=\"legend hl-cyan\" aria-hidden=\"true\">\u003C/span> = clinical picture )\n    \u003C/p>\n  \u003C/div>\n  \u003Cp>\n    A software device indicated for the \u003Cmark class=\"hl hl-yellow\">prediction of stroke\u003C/mark>. It\n    is indicated in patients with \u003Cmark class=\"hl hl-cyan\">atrial fibrillation\u003C/mark> […]\n  \u003C/p>\n\u003C/div>\n\u003Cp>\n  This software score calculator is indicated for the prediction of stroke. The device’s purpose is\n  to prevent stroke from occurring. Therefore, at the time the device is used, the patient cannot\n  have developed this condition yet. The clinical picture, instead, specifies another condition\n  (atrial fibrillation) that must have been diagnosed in the patient before a user can utilize the\n  device.\n\u003C/p>\n\u003Ch4 id=\"the-clinical-picture-is-postdiagnostic\">The clinical picture is postdiagnostic\u003C/h4>\n\u003Cp>\n  For purposes other than diagnosis, prevention, and prediciton, the clinical picture can be\n  postdiagnostic. This implies that the subject has already received a diagnosis for a condition. In\n  such cases, the clinical picture can provide additional insights into the condition. For instance,\n  it might specify the severity or stage of the condition in more detail. Consider the following\n  examples:\n\u003C/p>\n\u003Cdiv class=\"examplebox\">\n  \u003Cdiv class=\"boxtitle\">\n    \u003Cp>\n      Example: Extracorporeal shock wave lithotripsy device (\n      \u003Cspan class=\"legend hl-yellow\" aria-hidden=\"true\">\u003C/span> = indication;\n      \u003Cspan class=\"legend hl-cyan\" aria-hidden=\"true\">\u003C/span> = clinical picture )\n    \u003C/p>\n  \u003C/div>\n  \u003Cp>\n    A system for the \u003Cmark class=\"hl hl-yellow\">treatment of kidney stones\u003C/mark>. It can be used\n    with\n    \u003Cmark class=\"hl hl-cyan\"\n      >patients with kidney stones of moderate size (smaller than 2 cm), and are located in the\n      kidneys or the upper ureters\u003C/mark\n    >. […]\n  \u003C/p>\n\u003C/div>\n\u003Ch3 id=\"multiple-target-populations\">5.3 Multiple target populations\u003C/h3>\n\u003Cp>\n  Like indications, a device can have several different target populations. The following example\n  includes two distinct patient populations (treatment of psoriasis in adults and treatment of\n  eczema in children):\n\u003C/p>\n\u003Cdiv class=\"examplebox\">\n  \u003Cdiv class=\"boxtitle\">\n    \u003Cp>\n      Example: Phototherapy device ( \u003Cspan class=\"legend hl-lilac\" aria-hidden=\"true\">\u003C/span> =\n      demographics; \u003Cspan class=\"legend hl-cyan\" aria-hidden=\"true\">\u003C/span> = clinical picture )\n    \u003C/p>\n  \u003C/div>\n  \u003Cp>\n    A phototherapy device that emits UVB and UVA radiation. The device is indicated for the\n    treatment of psoriasis and eczema. Specifically, the device is indicated for\n    \u003Cmark class=\"hl hl-lilac\">adult patients (maximum height 190 cm)\u003C/mark> with\n    \u003Cmark class=\"hl hl-cyan\">moderate to severe psoriasis\u003C/mark> and for\n    \u003Cmark class=\"hl hl-lilac\">pediatric patients (aged 6-17 years)\u003C/mark>\n    \u003Cmark class=\"hl hl-cyan\"\n      >with eczema who have not responded adequately to conventional treatments\u003C/mark\n    >. […]\n  \u003C/p>\n\u003C/div>\n\u003Cp>\n  The two target populations will require separate considerations for certification (risk\n  management, clinical validation, post-market surveillance, etc.).\n\u003C/p>\n\u003Ch3 id=\"contraindications-and-warnings\">5.4 Contraindications and warnings\u003C/h3>\n\u003Cp>\n  Contraindications can be though of as the “opposite\" of the target population: they specify the\n  demographics and clinical conditions of the patients for whom the device should \u003Cem>not\u003C/em> be\n  used. For those familiar with clinical studies, this part of the intended purpose can be likened\n  to the exclusion criteria of a clinical investigation.\n\u003C/p>\n\u003Cdiv class=\"warningbox\">\n  \u003Cdiv class=\"boxtitle\" id=\"box-3\">\u003Cp>Box 3: Contraindication vs. complication\u003C/p>\u003C/div>\n  \u003Cp>\n    Do not confuse contraindications and complications. \u003Cem>Contraindications\u003C/em> are conditions or\n    factors that serve as reason not to use a medical device with a patient. \u003Cem>Complications\u003C/em>,\n    on the other hand, are problems or side effects that arise during or after the treatment.\n    Complications are detailed—together with the device risks and side-effects—in the instructions\n    for use.\n  \u003C/p>\n\u003C/div>\n\u003Cp>Consider an example:\u003C/p>\n\u003Cdiv class=\"examplebox\">\n  \u003Cdiv class=\"boxtitle\">\n    \u003Cp>\n      Example: Lung-cancer detection AI system (\n      \u003Cspan class=\"legend hl-yellow\" aria-hidden=\"true\">\u003C/span> = indication;\n      \u003Cspan class=\"legend hl-red\" aria-hidden=\"true\">\u003C/span> = contraindication )\n    \u003C/p>\n  \u003C/div>\n  \u003Cp>\n    A software AI system intended to\n    \u003Cmark class=\"hl hl-yellow\"\n      >provide information which is used for the diagnosis lung cancer\u003C/mark\n    >\n    […] The device\n    \u003Cmark class=\"hl hl-red\"\n      >is not applicable for patients who have already undergone significant treatment (e.g.,\n      surgery, chemotherapy, radiation therapy)\u003C/mark\n    >\n    as these treatments can alter the appearance of the tumor and surrounding tissues. […]\n  \u003C/p>\n\u003C/div>\n\u003Cp>\n  In this case, the contraindications outline clinical factors that prevent the use of the device.\n  However, there are situations where you must specify non clinical criteria for not using the\n  device. These criteria are referred to as warnings. Let’s consider an example:\n\u003C/p>\n\u003Cdiv class=\"examplebox\">\n  \u003Cdiv class=\"boxtitle\">\n    \u003Cp>\n      Example: Glucose monitor ( \u003Cspan class=\"legend hl-yellow\" aria-hidden=\"true\">\u003C/span> =\n      indication; \u003Cspan class=\"legend hl-red\" aria-hidden=\"true\">\u003C/span> = warning )\n    \u003C/p>\n  \u003C/div>\n  \u003Cp>\n    A continuous glucose monitoring system intended for use by individuals with diabetes to\n    \u003Cmark class=\"hl hl-yellow\">monitor blood glucose levels\u003C/mark> […] The device\n    \u003Cmark class=\"hl hl-red\"\n      >should not be used to measure glucose immediately after eating (immediate postprandial), as\n      this may lead to innacurate readings.\u003C/mark\n    >\n    […]\n  \u003C/p>\n\u003C/div>\n\u003Cp>\n  In this case, “immediate postprandial\" is neither a demographics characteristic of the patient,\n  nor a clinical condition. However, it is a factor that could affect the reliability of the device.\n\u003C/p>\n\u003Cdiv class=\"warningbox\">\n  \u003Cdiv class=\"boxtitle\" id=\"box-4\">\u003Cp>Box 4: Select the relevant warnings carefully\u003C/p>\u003C/div>\n  \u003Cp>\n    The intended purpose should only include warnings essential to the device’s application. It\n    should not just list all warnings from the user manual.\n  \u003C/p>\n\u003C/div>\n\u003Ch2 id=\"intended-users\">6 Intended user(s)\u003C/h2>\n\u003Cp>\n  In the intended purpose, you should provide two essential pieces of information concerning the\n  user:\n\u003C/p>\n\u003Col>\n  \u003Cli>\u003Cp>State whether the user is a healthcare professional, a layperson, or both.\u003C/p>\u003C/li>\n  \u003Cli>\u003Cp>State whether the patient is also a user.\u003C/p>\u003C/li>\n\u003C/ol>\n\u003Cp>\n  If the patient is a user, the intended user must include lay users. Additionally, note that in\n  most countries only healthcare professionals are allowed to emit diagnoses and prognoses. Devices\n  intended to provide information that is used for diagnosis or prognosis must include healthcare\n  professionals as user.\n\u003C/p>\n\u003Cp>\n  Additional information, such as the user’s type and level of education, and requirements\n  concerning device-specific training, should be provided separately in the instructions for use.\n\u003C/p>\n\u003Cdiv class=\"warningbox\">\n  \u003Cdiv class=\"boxtitle\" id=\"box-5\">\u003Cp>Box 5: Intended user vs. IEC 62366\u003C/p>\u003C/div>\n  \u003Cp>\n    In the intended purpose, you only need to specify the users who utilize the device to achieve\n    its medical purpose. It is not necessary to list all users, such as those involved in service,\n    maintenance, and cleaning, as required by \u003Ca href=\"#ref-iec-62366\">IEC 62366\u003C/a>. Detailed\n    specifications for these additional users can be provided in the instructions for use.\n  \u003C/p>\n\u003C/div>\n\u003Ch2 id=\"relevant-safety-and-performance-information\">\n  7 Relevant safety and performance information\n\u003C/h2>\n\u003Cdiv id=\"sec-gspr\">\u003C/div>\n\u003Cp>\n  Indications, target population, contraindications, warnings, and intended users are the essential\n  pieces of information that must be specified for any device’s intended purpose. However, it is\n  sometimes consigliabile to provide additional information relevant to understanding the\n  device-specific application. If you feel uncertain about what to include, here is a tip: refer to\n  the list of design-related requirements in Chapter II of \u003Ca href=\"#ref-mdr\">MDR\u003C/a> Annex I. If\n  these s highlight a specific characteristic, you should include this characteristic in the\n  intended purpose. Below is a (non-exhaustive) list of characteristics to consider.\n\u003C/p>\n\u003Ch3 id=\"invasiveness\">7.1 Invasiveness\u003C/h3>\n\u003Cp>\n  State if the device is invasive (see \u003Ca href=\"#ref-mdr\">MDR\u003C/a> Article 2.6) or or surgically\n  invasive (see \u003Ca href=\"#ref-mdr\">MDR\u003C/a> Annex VIII, Part 2.2).\n\u003C/p>\n\u003Ch3 id=\"implant\">7.2 Implant\u003C/h3>\n\u003Cp>State if the device is implantable (see \u003Ca href=\"#ref-mdr\">MDR\u003C/a> Article 2.5).\u003C/p>\n\u003Ch3 id=\"personalization\">7.3 Personalization\u003C/h3>\n\u003Cp>\n  State if the device is custom-made (see \u003Ca href=\"#ref-mdr\">MDR\u003C/a> Article 2.3). You can also\n  specify whether the device is adaptable or patient-made according to the definition from IMDRF\n  (see \u003Ca href=\"#ref-imdrf-n58\">IMDRF WG/N58\u003C/a>) even though these terms are not directly defined\n  in the \u003Ca href=\"#ref-mdr\">MDR\u003C/a>.\n\u003C/p>\n\u003Ch3 id=\"microbial-state-status\">7.4 Microbial state status\u003C/h3>\n\u003Cp>State if the device is provided sterile.\u003C/p>\n\u003Ch3 id=\"reusability\">7.5 Reusability\u003C/h3>\n\u003Cp>State if the device is single-use or reusable.\u003C/p>\n\u003Ch3 id=\"measuring-function\">7.6 Measuring function\u003C/h3>\n\u003Cp>\u003Ca href=\"#ref-mdcg-2021-24\">MDCG 2021-24\u003C/a> defines measuring function as follows\u003C/p>\n\u003Cblockquote>\n  \u003Cp>\n    The following criteria, if fulfilled together, indicate that a device has a measuring function:\n  \u003C/p>\n  \u003Col>\n    \u003Cli>\n      \u003Cp>The device is intended by the manufacturer to measure:\u003C/p>\n      \u003Cul>\n        \u003Cli>\u003Cp>quantitatively a physiological or anatomical parameter, or\u003C/p>\u003C/li>\n        \u003Cli>\n          \u003Cp>\n            a quantity or a quantifiable characteristic of energy or of substances (including\n            medicinal products) delivered to or removed from the human body. Spoons or plastic\n            syringes co-packed with medicinal products and used to measure a quantity of that\n            medicinal product to be administered to the patient are in this category. Devices for\n            the delivery of liquid to the human body without graduation or scale (e.g. medicine\n            spoons, cups, droppers without graduation or scale or display of measuring unit) are not\n            in this category.\u003Ca href=\"#fn2\" class=\"footnote-ref\" id=\"fnref2\" role=\"doc-noteref\"\n              >\u003Csup>2\u003C/sup>\u003C/a\n            >\n          \u003C/p>\n        \u003C/li>\n      \u003C/ul>\n    \u003C/li>\n    \u003Cli>\n      \u003Cp>The result of the measurement:\u003C/p>\n      \u003Cul>\n        \u003Cli>\n          \u003Cp>\n            is displayed in legal units or other acceptable units within the meaning of Directive\n            80/181/EEC,\u003Ca href=\"#fn3\" class=\"footnote-ref\" id=\"fnref3\" role=\"doc-noteref\"\n              >\u003Csup>3\u003C/sup>\u003C/a\n            >\n            or\n          \u003C/p>\n        \u003C/li>\n        \u003Cli>\n          \u003Cp>\n            is compared to at least one point of reference indicated in legal units or other\n            acceptable units in compliance with the mentioned directive.\n          \u003C/p>\n        \u003C/li>\n      \u003C/ul>\n    \u003C/li>\n    \u003Cli>\n      \u003Cp>\n        The intended purpose implies accuracy, claimed explicitly or implicitly, where a\n        non-compliance with the implied accuracy could result in a significant adverse effect on the\n        patient’s health and safety.\n      \u003C/p>\n      \u003Cp>\n        The expression ‘claimed implicitly’ covers cases where the user, on the basis of the\n        designation of the device or of its accompanying documents, or on the basis of the common\n        use, is entitled to expect accuracy where the accuracy of the measurement has an impact on\n        the diagnosis or therapy of the patient.\n      \u003C/p>\n    \u003C/li>\n  \u003C/ol>\n  \u003Cp>\n    Measuring activities during the manufacturing process including those for calibration purposes\n    are not covered and do not imply a measuring function of the manufactured device.\n  \u003C/p>\n\u003C/blockquote>\n\u003Ch3 id=\"substances\">7.7 Substances\u003C/h3>\n\u003Ch5 id=\"devices-incorporating-or-consisting-of-substances\">\n  Devices incorporating or consisting of substances\n\u003C/h5>\n\u003Cp>State whether the device incorporates or consists of:\u003C/p>\n\u003Cul>\n  \u003Cli>\u003Cp>Medicinal products (including substances derived from human blood, or huma plasma)\u003C/p>\u003C/li>\n  \u003Cli>\u003Cp>Non-viable tissues or cells, or their derivatives, of human origin\u003C/p>\u003C/li>\n  \u003Cli>\u003Cp>Non-viable tissues or cells, or their derivatives, of animal origin\u003C/p>\u003C/li>\n  \u003Cli>\u003Cp>Other non viable substances of biological origins (e.g., bacteria, fungi, viruses)\u003C/p>\u003C/li>\n  \u003Cli>\u003Cp>Gases\u003C/p>\u003C/li>\n  \u003Cli>\u003Cp>Latex\u003C/p>\u003C/li>\n  \u003Cli>\u003Cp>Nanomaterials\u003C/p>\u003C/li>\n  \u003Cli>\u003Cp>Substances which are carcinogenic, mutagenic or toxic to reproduction\u003C/p>\u003C/li>\n  \u003Cli>\u003Cp>Substances having endocrine-disrupting properties\u003C/p>\u003C/li>\n  \u003Cli>\u003Cp>Other substances (specifies)\u003C/p>\u003C/li>\n\u003C/ul>\n\u003Ch5 id=\"absorbed-and-dispersed-substances\">Absorbed and dispersed substances\u003C/h5>\n\u003Cp>\n  State whether the device is composed of substances (or combinations of substances) that are\n  introduced into the body or applied to the skin, and that are absorbed by or locally dispersed in\n  the body. These substances can include:\n\u003C/p>\n\u003Cul>\n  \u003Cli>\u003Cp>Non-viable tissues or cells, or their derivatives, of human origin\u003C/p>\u003C/li>\n  \u003Cli>\u003Cp>Non-viable tissues or cells, or their derivatives, of animal origin\u003C/p>\u003C/li>\n  \u003Cli>\u003Cp>Other non viable substances of biological origins (e.g., bacteria, fungi, viruses)\u003C/p>\u003C/li>\n  \u003Cli>\u003Cp>Gases\u003C/p>\u003C/li>\n  \u003Cli>\u003Cp>Other substances (specify)\u003C/p>\u003C/li>\n\u003C/ul>\n\u003Ch5 id=\"administered-substances\">Administered substances\u003C/h5>\n\u003Cp>State whether the device administers:\u003C/p>\n\u003Cul>\n  \u003Cli>\u003Cp>Medicinal products (including substances derived from human blood, or huma plasma)\u003C/p>\u003C/li>\n  \u003Cli>\u003Cp>Non-viable tissues or cells, or their derivatives, of human origin\u003C/p>\u003C/li>\n  \u003Cli>\u003Cp>Non-viable tissues or cells, or their derivatives, of animal origin\u003C/p>\u003C/li>\n  \u003Cli>\u003Cp>Other non viable substances of biological origins (e.g., bacteria, fungi, viruses)\u003C/p>\u003C/li>\n  \u003Cli>\u003Cp>Gases\u003C/p>\u003C/li>\n  \u003Cli>\u003Cp>Other substances (specifies)\u003C/p>\u003C/li>\n\u003C/ul>\n\u003Ch5 id=\"removed-substances\">Removed substances\u003C/h5>\n\u003Cp>State whether the device removes any of the following substances from the body:\u003C/p>\n\u003Cul>\n  \u003Cli>\u003Cp>Medicinal products (including substances derived from human blood, or huma plasma)\u003C/p>\u003C/li>\n  \u003Cli>\u003Cp>Non-viable tissues or cells, or their derivatives, of human origin\u003C/p>\u003C/li>\n  \u003Cli>\u003Cp>Non-viable tissues or cells, or their derivatives, of animal origin\u003C/p>\u003C/li>\n  \u003Cli>\u003Cp>Other non viable substances of biological origins (e.g., bacteria, fungi, viruses)\u003C/p>\u003C/li>\n  \u003Cli>\u003Cp>Gases\u003C/p>\u003C/li>\n  \u003Cli>\u003Cp>Other substances (specifies)\u003C/p>\u003C/li>\n\u003C/ul>\n\u003Ch3 id=\"radiation\">7.8 Radiation\u003C/h3>\n\u003Cp>\n  State whether the device emits radiation for medical purposes and specify the radiation type (UVA,\n  UVB, UVC, infrared, ionising, etc.).\n\u003C/p>\n\u003Ch3 id=\"energy-supplied-to-the-patient\">7.9 Energy supplied to the patient\u003C/h3>\n\u003Cp>\n  State whether the device supplies energy to the patient and specify the energy type (e.g.,\n  electrical, magnetic, mechanical, thermal, acoustic, etc.).\n\u003C/p>\n\u003Ch3 id=\"power-supply\">7.10 Power supply\u003C/h3>\n\u003Cp>\n  State whether the device has an internal power supply and its type (e.g., disposable batteries,\n  rechargeable batteries, etc.). State whether the device has an external power supply and its type\n  (e.g., AC mains, DC, USB, wireless, etc.).\n\u003C/p>\n\u003Ch3 id=\"compatibilities\">7.11 Compatibilities\u003C/h3>\n\u003Cp>\n  Specify whether the device is intended for use in combination with other devices or equipment, or\n  within a specific medical procedure.\n\u003C/p>\n\u003Ch2 class=\"unnumbered\" id=\"references\">References\u003C/h2>\n\u003Cul>\n  \u003Cli>\n    \u003Cdiv id=\"ref-iec-62366\">\u003C/div>\n    \u003Cp>\n      \u003Cstrong>IEC 62366\u003C/strong> — Medical Devices – Application of Usability Engineering to Medical\n      Devices. IEC, 2015\n    \u003C/p>\n  \u003C/li>\n  \u003Cli>\n    \u003Cdiv id=\"ref-imdrf-n47\">\u003C/div>\n    \u003Cp>\n      \u003Cstrong>IMDRF WG/N47\u003C/strong> — Essential Principles of Safety and Performance of Medical\n      Devices and IVD Medical Devices. IMDRF, 2021\n    \u003C/p>\n  \u003C/li>\n  \u003Cli>\n    \u003Cdiv id=\"ref-imdrf-n58\">\u003C/div>\n    \u003Cp>\u003Cstrong>IMDRF WG/N58\u003C/strong> — Personalized Medical Devices. IMDRF, 2020\u003C/p>\n  \u003C/li>\n  \u003Cli>\n    \u003Cdiv id=\"ref-imdrf-n9\">\u003C/div>\n    \u003Cp>\n      \u003Cstrong>IMDRF WG/N9\u003C/strong> — Non-In Vitro Diagnostic Device Regulatory Submission Table of\n      Contents (nIVD ToC). IMDRF, 2024\n    \u003C/p>\n  \u003C/li>\n  \u003Cli>\n    \u003Cdiv id=\"ref-mdcg-2019-11\">\u003C/div>\n    \u003Cp>\n      \u003Cstrong>MDCG 2019-11\u003C/strong> — Guidance on Qualification and Classification of Software in\n      Regulation (EU) 2017/745 – MDR and Regulation (EU) 2017/746 – IVDR. MDCG, 2019\n    \u003C/p>\n  \u003C/li>\n  \u003Cli>\n    \u003Cdiv id=\"ref-mdcg-2020-6\">\u003C/div>\n    \u003Cp>\n      \u003Cstrong>MDCG 2020-6\u003C/strong> — Regulation (EU) 2017/745: Clinical evidence needed for medical\n      devices previously CE marked under Directives 93/42/EEC or 90/385/EEC. MDCG, 2020\n    \u003C/p>\n  \u003C/li>\n  \u003Cli>\n    \u003Cdiv id=\"ref-mdcg-2021-24\">\u003C/div>\n    \u003Cp>\u003Cstrong>MDCG 2021-24\u003C/strong> — Guidance on classification of medical devices. MDCG, 2021\u003C/p>\n  \u003C/li>\n  \u003Cli>\n    \u003Cdiv id=\"ref-mdcg-2022-9\">\u003C/div>\n    \u003Cp>\u003Cstrong>MDCG 2022-9\u003C/strong> — Summary of Safety and Performance Template. MDCG, 2024\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\u003C/ul>\n\u003Csection id=\"footnotes\" class=\"footnotes footnotes-end-of-document\" role=\"doc-endnotes\">\n  \u003Chr />\n  \u003Col>\n    \u003Cli id=\"fn1\">\n      \u003Cp>\n        Claims are not part of the intended purpose. The topic of performance, clinical, and benefit\n        claims will be addressed in a separate document.\u003Ca\n          href=\"#fnref1\"\n          class=\"footnote-back\"\n          role=\"doc-backlink\"\n          >↩︎\u003C/a\n        >\n      \u003C/p>\n    \u003C/li>\n    \u003Cli id=\"fn2\">\n      \u003Cp>MDCG 2021-24\u003Ca href=\"#fnref2\" class=\"footnote-back\" role=\"doc-backlink\">↩︎\u003C/a>\u003C/p>\n    \u003C/li>\n    \u003Cli id=\"fn3\">\n      \u003Cp>\n        Council Directive 80/181/EEC of 20 December 1979 on the approximation of the laws of the\n        Member States relating to units of measurement\u003Ca\n          href=\"#fnref3\"\n          class=\"footnote-back\"\n          role=\"doc-backlink\"\n          >↩︎\u003C/a\n        >\n      \u003C/p>\n    \u003C/li>\n  \u003C/ol>\n\u003C/section>\n",1792608381978]