[{"data":1,"prerenderedAt":4},["ShallowReactive",2],{"guide-well-established-technology":3},"\u003Ch2 id=\"mdr-wet\">1 MDR-WET\u003C/h2>\n\u003Cp>\u003Cspan>=Common Specifications (CS)\u003C/span>\u003C/p>\n\u003Cfigure>\n  \u003Cimg src=\"/guides/well-established-technology/figure-1.svg\" />\n  \u003Cdiv id=\"fig-mdr-wet\">\u003C/div>\n  \u003Cfigcaption>\n    Figure 1: Class IIb implantables and Class III devices that qualify as MDR–WET benefit from the\n    exemptions provided in \u003Ca href=\"#ref-mdr\">MDR\u003C/a> Article 52(4) (assessment based on\n    representative devices) and Article 61(6)(b) (exemption from mandatory clinical investigations).\n    The figure also highlights that legacy devices may benefit from Article 61(6)(a), which provides\n    the same exemption from the requirement to conduct a clinical investigation as Article 61(6)(b).\n  \u003C/figcaption>\n\u003C/figure>\n\u003Cp>\n  The \u003Ca href=\"#ref-mdr\">MDR\u003C/a> does not define what it means for a technology to be\n  \"well-established\". This is not an oversight. For the purposes of the regulation, a formal\n  definition simply is unnecessary. Let’s see why.\n\u003C/p>\n\u003Cp>\n  The expression Well-Established Technology (WET) appears in \u003Ca href=\"#ref-mdr\">MDR\u003C/a> Article\n  52(5) and Article 61(8). Here it is used in reference to the following class IIb implantable or\n  class III devices: sutures, staples, dental fillings, dental braces, tooth crowns, screws, wedges,\n  plates, wires, pins, clips, and connectors. These devices have been singled out by the European\n  Commission for a more favorable regulatory treatment compared to other class IIb implantable or\n  class III, Figure \u003Ca href=\"#fig-mdr-wet\">1\u003C/a>. The advantages include:\n\u003C/p>\n\u003Cul>\n  \u003Cli>\n    \u003Cp>\n      \u003Cstrong>Assessment based on representative devices\u003C/strong> (Article 52(4)):\u003Cbr />\n      For MDR–WET devices, the technical documentation does not need to be submitted and assessed\n      individually for every device within a generic device group. Instead, a sample or\n      representative device can be used to demonstrate conformity for the entire group. This\n      significantly reduces the regulatory burden and accelerates the conformity assessment process.\n    \u003C/p>\n  \u003C/li>\n  \u003Cli>\n    \u003Cp>\n      \u003Cstrong>Exemption from mandatory clinical investigations\u003C/strong> (Article 61(6)(b)):\u003Cbr />\n      If the device qualifies as MDR–WET, the manufacturer may be exempt from conducting new\n      clinical investigations, provided that sufficient clinical data already exist. This can lead\n      to significant time and cost savings, particularly for implantable or Class III devices, where\n      clinical investigations are otherwise extensive and resource-intensive.\n    \u003C/p>\n  \u003C/li>\n\u003C/ul>\n\u003Cp>\n  In the \u003Ca href=\"#ref-mdr\">MDR\u003C/a> the expression \"well-established\", therefore, does not\n  explicitly imply any specific technological or clinical status. If we were to infer an\n  \u003Ca href=\"#ref-mdr\">MDR\u003C/a> definition of well-established technology–which we will refer to as\n  \u003Cem>MDR–WET\u003C/em>–based solely on these two articles, it would essentially be limited to the\n  following characteristics:\n\u003C/p>\n\u003Col>\n  \u003Cli>\u003Cp>class IIb implantables or class III\u003C/p>\u003C/li>\n  \u003Cli>\u003Cp>explicitely selected by the European Commission\u003C/p>\u003C/li>\n\u003C/ol>\n\u003Cp>\n  The \u003Ca href=\"#ref-mdr\">MDR\u003C/a> is also unequivocal on one point: The authority to amend the list\n  of devices that benefit from the favorable treatment lies \u003Cem>solely\u003C/em> with the European\n  Commission. In other words: Manufacturers of devices \u003Cem>other than\u003C/em> sutures, staples, dental\n  fillings, dental braces, tooth crowns, screws, wedges, plates, wires, pins, clips, and connectors\n  \u003Cem>cannot\u003C/em> currently invoke the favourable provisions that specifically reduce the\n  certification burden for these designated devices specified in Article Articles 52(4) and\n  61(6)(b). Period.\n\u003C/p>\n\u003Cp>\n  If the \u003Ca href=\"#ref-mdr\">MDR\u003C/a> is clear on the matter, why did WET become such a hotly debated\n  topic in the field? The controversy began with \u003Ca href=\"#ref-mdcg-2020-6\">MDCG 2020-6\u003C/a>.\n\u003C/p>\n\u003Ch2 id=\"mdcgwet\">2 MDCG–WET\u003C/h2>\n\u003Cp>\n  In 2020, the Medical Device Coordination Group (MDCG) released guidance\n  \u003Ca href=\"#ref-mdcg-2020-6\">MDCG 2020-6\u003C/a> outlining a set of characteristics that it considers\n  common to the products specifically mentioned in the \u003Ca href=\"#ref-mdr\">MDR\u003C/a>—namely, sutures,\n  staples, dental fillings, dental braces, tooth crowns, screws, wedges, plates, wires, pins, clips,\n  and connectors. According to the MDCG, these characteristics are:\n\u003C/p>\n\u003Col>\n  \u003Cli>\u003Cp>relatively simple, common and stable designs with little evolution;\u003C/p>\u003C/li>\n  \u003Cli>\n    \u003Cp>\n      their generic device group has well-known safety and has not been associated with safety\n      issues in the past;\n    \u003C/p>\n  \u003C/li>\n  \u003Cli>\n    \u003Cp>\n      well-known clinical performance characteristics and their generic device group are standard of\n      care devices where there is little evolution in indications and the state of the art;\n    \u003C/p>\n  \u003C/li>\n  \u003Cli>\u003Cp>a long history on the market.\u003C/p>\u003C/li>\n\u003C/ol>\n\u003Cp>\n  These properties define what we’ll refer to as an \"MDCG–WET\". As highlighted in Table\n  \u003Ca href=\"#tab-mdrvsmdcg-wet\">1\u003C/a>, the MDCG–WET definition strongly differs from the MDR–WET\n  discussed in the previous section.\n\u003C/p>\n\u003Cdiv class=\"table-wrap\">\n  \u003Ctable>\n    \u003Ccaption>\n      Table 1: Comparison between the MDR–WET and MDCG–WET definitions.\n    \u003C/caption>\n    \u003Ctbody>\n      \u003Ctr class=\"odd\">\n        \u003Ctd style=\"text-align: left\" class=\"cell-gray20\">\u003Cstrong>MDR–WET\u003C/strong>\u003C/td>\n        \u003Ctd style=\"text-align: left\" class=\"cell-gray20\">\u003Cstrong>MDCG–WET\u003C/strong>\u003C/td>\n      \u003C/tr>\n      \u003Ctr class=\"even\">\n        \u003Ctd style=\"text-align: left\" class=\"cell-verylightgray\">\n          \u003Cem>Class:\u003C/em> Class IIb implantable and Class III devices\n        \u003C/td>\n        \u003Ctd style=\"text-align: left\" class=\"cell-verylightgray\">\n          \u003Cem>Class:\u003C/em> Applicable to any class (\u003Ca href=\"#ref-mdcg-2020-6\">MDCG 2020-6\u003C/a>, page\n          5); however, the suggested hierarchy of evidence outlined in Annex III of\n          \u003Ca href=\"#ref-mdcg-2020-6\">MDCG 2020-6\u003C/a> specifically applies to Class IIb implantable\n          and Class III devices.\n        \u003C/td>\n      \u003C/tr>\n      \u003Ctr class=\"odd\">\n        \u003Ctd style=\"text-align: left\" class=\"cell-verylightgray\">\n          \u003Cem>Legacy status:\u003C/em> Applicable to legacy and non legacy devices (\u003Ca\n            href=\"#ref-mdcg-2020-6\"\n            >MDCG 2020-6\u003C/a\n          >, page 5).\n        \u003C/td>\n        \u003Ctd style=\"text-align: left\" class=\"cell-verylightgray\">\n          \u003Cem>Legacy status:\u003C/em> Applicable to legacy and non-legacy devices; however, the\n          suggested hierarchy of evidence outlined in Annex III of\n          \u003Ca href=\"#ref-mdcg-2020-6\">MDCG 2020-6\u003C/a> specifically applies to legacy devices.\n        \u003C/td>\n      \u003C/tr>\n      \u003Ctr class=\"even\">\n        \u003Ctd style=\"text-align: left\" class=\"cell-verylightgray\">\n          \u003Cem>Device type:\u003C/em> Applicable only to sutures, staples, dental fillings, dental braces,\n          tooth crowns, screws, wedges, plates, wires, pins, clips, and connectors\n        \u003C/td>\n        \u003Ctd style=\"text-align: left\">\n          \u003Cp>\n            \u003Cem>Device type:\u003C/em> applicable to devices that fulfill the following requirements:\n          \u003C/p>\n          \u003Cul>\n            \u003Cli>\u003Cp>Relatively simple, common and stable designs with little evolution;\u003C/p>\u003C/li>\n            \u003Cli>\n              \u003Cp>\n                Their generic device group has well-known safety and has not been associated with\n                safety issues in the past;\n              \u003C/p>\n            \u003C/li>\n            \u003Cli>\n              \u003Cp>\n                Well-known clinical performance characteristics and their generic device group are\n                standard of care devices where there is little evolution in indications and the\n                state of the art;\n              \u003C/p>\n            \u003C/li>\n            \u003Cli>\u003Cp>A long history on the market.\u003C/p>\u003C/li>\n          \u003C/ul>\n        \u003C/td>\n      \u003C/tr>\n    \u003C/tbody>\n  \u003C/table>\n\u003C/div>\n\u003Cdiv id=\"tab-mdrvsmdcg-wet\">\u003C/div>\n\u003Cp>\n  Each of the four criteria in the MDCG-WET definition consists of multiple elements—each of\n  requirements which must be demonstrated separately. In Table \u003Ca href=\"#fig-mdcg-wet\">2\u003C/a> we\n  illustrates these requirements and propose how to demonstrate MDCG–WET status using documents\n  specific to the device under evaluation (device description, device history, vigilance data), SOTA\n  reviews and meta-analyses (medical background\u003Ca\n    href=\"#fn1\"\n    class=\"footnote-ref\"\n    id=\"fnref1\"\n    role=\"doc-noteref\"\n    >\u003Csup>1\u003C/sup>\u003C/a\n  >, meta-analyses or umbrella reviews of device group performance and safety characteristics\u003Ca\n    href=\"#fn2\"\n    class=\"footnote-ref\"\n    id=\"fnref2\"\n    role=\"doc-noteref\"\n    >\u003Csup>2\u003C/sup>\u003C/a\n  >), and post-market literature searches focusing on similar devices\u003Ca\n    href=\"#fn3\"\n    class=\"footnote-ref\"\n    id=\"fnref3\"\n    role=\"doc-noteref\"\n    >\u003Csup>3\u003C/sup>\u003C/a\n  >.\n\u003C/p>\n\u003Cdiv class=\"table-wrap\">\n  \u003Ctable>\n    \u003Ccaption>\n      Table 2: Mapping of evidence sources to the four MDCG–WET criteria.\n    \u003C/caption>\n    \u003Ctbody>\n      \u003Ctr class=\"odd\">\n        \u003Ctd style=\"text-align: left\" class=\"cell-gray20\">\u003Cstrong>Evidence\u003C/strong>\u003C/td>\n        \u003Ctd style=\"text-align: left\" class=\"cell-gray20\">\u003Cstrong>Criterion 1\u003C/strong>\u003C/td>\n        \u003Ctd style=\"text-align: left\" class=\"cell-gray20\">\u003Cstrong>Criterion 2\u003C/strong>\u003C/td>\n        \u003Ctd style=\"text-align: left\" class=\"cell-gray20\">\u003Cstrong>Criterion 3\u003C/strong>\u003C/td>\n        \u003Ctd style=\"text-align: left\" class=\"cell-gray20\">\u003Cstrong>Criterion 4\u003C/strong>\u003C/td>\n      \u003C/tr>\n      \u003Ctr class=\"even\">\n        \u003Ctd style=\"text-align: left\" class=\"cell-gray20\">\n          \u003Cstrong\n            >SOTA reviews addressing the medical background and the generic device group\u003C/strong\n          >\n        \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\" class=\"cell-gray20\">SOTA medical background\u003C/td>\n        \u003Ctd style=\"text-align: left\" class=\"cell-verylightgray\">\u003C/td>\n        \u003Ctd style=\"text-align: left\" class=\"cell-verylightgray\">\u003C/td>\n        \u003Ctd style=\"text-align: left\" class=\"cell-lightgreen\">\n          Device group has is considered standard of care\n        \u003C/td>\n        \u003Ctd style=\"text-align: left\" class=\"cell-verylightgray\">\u003C/td>\n      \u003C/tr>\n      \u003Ctr class=\"even\">\n        \u003Ctd style=\"text-align: left\" class=\"cell-gray20\">SOTA device group meta-analysis\u003C/td>\n        \u003Ctd style=\"text-align: left\" class=\"cell-verylightgray\">\u003C/td>\n        \u003Ctd style=\"text-align: left\" class=\"cell-lightgreen\">\n          Device group has a well-known safety profile\n        \u003C/td>\n        \u003Ctd style=\"text-align: left\" class=\"cell-lightgreen\">\n          \u003Cp>Device group has:\u003C/p>\n          \u003Cul>\n            \u003Cli>\u003Cp>well-known clinical performance characteristics\u003C/p>\u003C/li>\n            \u003Cli>\u003Cp>little change in SOTA\u003C/p>\u003C/li>\n          \u003C/ul>\n        \u003C/td>\n        \u003Ctd style=\"text-align: left\" class=\"cell-verylightgray\">\u003C/td>\n      \u003C/tr>\n      \u003Ctr class=\"odd\">\n        \u003Ctd style=\"text-align: left\" class=\"cell-gray20\">SOTA market analysis\u003C/td>\n        \u003Ctd style=\"text-align: left\" class=\"cell-lightgreen\">\n          \u003Cp>Device group has:\u003C/p>\n          \u003Cul>\n            \u003Cli>\u003Cp>common design\u003C/p>\u003C/li>\n            \u003Cli>\u003Cp>similar to that of DUE\u003C/p>\u003C/li>\n            \u003Cli>\u003Cp>with little evolution\u003C/p>\u003C/li>\n          \u003C/ul>\n        \u003C/td>\n        \u003Ctd style=\"text-align: left\" class=\"cell-verylightgray\">\u003C/td>\n        \u003Ctd style=\"text-align: left\" class=\"cell-lightgreen\">\n          Device group had little change in indications\n        \u003C/td>\n        \u003Ctd style=\"text-align: left\" class=\"cell-lightgreen\">\n          Device group has long history on the market\n        \u003C/td>\n      \u003C/tr>\n      \u003Ctr class=\"even\">\n        \u003Ctd style=\"text-align: left\" class=\"cell-gray20\">\n          \u003Cstrong>Documents specific to the Device Under Evaluation (DUE)\u003C/strong>\n        \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\" class=\"cell-gray20\">Functional specifications\u003C/td>\n        \u003Ctd style=\"text-align: left\" class=\"cell-lightgreen\">DUE has a simple design\u003C/td>\n        \u003Ctd style=\"text-align: left\" class=\"cell-verylightgray\">\u003C/td>\n        \u003Ctd style=\"text-align: left\" class=\"cell-verylightgray\">\u003C/td>\n        \u003Ctd style=\"text-align: left\" class=\"cell-verylightgray\">\u003C/td>\n      \u003C/tr>\n      \u003Ctr class=\"even\">\n        \u003Ctd style=\"text-align: left\" class=\"cell-gray20\">Device history\u003C/td>\n        \u003Ctd style=\"text-align: left\" class=\"cell-verylightgray\">\u003C/td>\n        \u003Ctd style=\"text-align: left\" class=\"cell-verylightgray\">\u003C/td>\n        \u003Ctd style=\"text-align: left\" class=\"cell-lightgreen\">\n          DUE has had little change in indications\n        \u003C/td>\n        \u003Ctd style=\"text-align: left\" class=\"cell-lightgreen\">\n          DUE has a long history on the market\n        \u003C/td>\n      \u003C/tr>\n      \u003Ctr class=\"odd\">\n        \u003Ctd style=\"text-align: left\" class=\"cell-gray20\">PSMR/PSUR\u003C/td>\n        \u003Ctd style=\"text-align: left\" class=\"cell-verylightgray\">\u003C/td>\n        \u003Ctd style=\"text-align: left\" class=\"cell-lightgreen\">\n          DUE not associated with significant safety issues\n        \u003C/td>\n        \u003Ctd style=\"text-align: left\" class=\"cell-verylightgray\">\u003C/td>\n        \u003Ctd style=\"text-align: left\" class=\"cell-verylightgray\">\u003C/td>\n      \u003C/tr>\n      \u003Ctr class=\"even\">\n        \u003Ctd style=\"text-align: left\" class=\"cell-gray20\">\n          \u003Cstrong>Post-market literature searches on similar devices\u003C/strong>\n        \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\" class=\"cell-gray20\">PMCF literature search\u003C/td>\n        \u003Ctd style=\"text-align: left\" class=\"cell-verylightgray\">\u003C/td>\n        \u003Ctd style=\"text-align: left\" class=\"cell-lightgreen\">\n          Similar devices have not been associated with significant safety issues in the past.\n        \u003C/td>\n        \u003Ctd style=\"text-align: left\" class=\"cell-verylightgray\">\u003C/td>\n        \u003Ctd style=\"text-align: left\" class=\"cell-verylightgray\">\u003C/td>\n      \u003C/tr>\n    \u003C/tbody>\n  \u003C/table>\n\u003C/div>\n\u003Cdiv id=\"tab-mdcg-wet-criteria\">\u003C/div>\n\u003Cp>\n  Below, we analyze how demonstrating MDCG–WET status affects the clinical evidence required for\n  conformity assessment, according to \u003Ca href=\"#ref-mdcg-2020-6\">MDCG 2020-6\u003C/a>.\n\u003C/p>\n\u003Cp>\n  First, \u003Ca href=\"#ref-mdcg-2020-6\">MDCG 2020-6\u003C/a> focuses on legacy devices—that is, devices\n  certified under \u003Ca href=\"#ref-mdd\">MDD\u003C/a> or \u003Ca href=\"#ref-aimdd\">AIMDD\u003C/a>. Even if these legacy\n  devices are not yet certified under the \u003Ca href=\"#ref-mdr\">MDR\u003C/a>, Article 120(3d) requires them\n  to comply with the \u003Ca href=\"#ref-mdr\">MDR\u003C/a>’s post-market surveillance requirements. This means\n  that legacy devices must have PMS data at their disposal—for example, complaints and vigilance\n  data. According to the definition in Article 2(48) of the \u003Ca href=\"#ref-mdr\">MDR\u003C/a>, such PMS\n  data qualify as \"clinical data\" and—as we know from Article 61(1)—clinical data form the basis for\n  demonstrating conformity with the relevant s in the clinical evaluation. So does this mean that\n  legacy devices automatically possess the data required for certification under the\n  \u003Ca href=\"#ref-mdr\">MDR\u003C/a>? \u003Ca href=\"#ref-mdcg-2020-6\">MDCG 2020-6\u003C/a> (pages 17 and 21) provides\n  a clear answer to this question: regardless of the device type, complaints and vigilance data may\n  only support other forms of clinical evidence—reliance on such data alone is\n  \u003Cem>not\u003C/em> sufficient.\n\u003C/p>\n\u003Cp>\n  Note that this requirement is not explicitly stated in the \u003Ca href=\"#ref-mdr\">MDR\u003C/a>. The\n  regulation merely states that PMS data—including complaints and vigilance data—are considered\n  clinical data. As such, the threshold set out in\n  \u003Ca href=\"#ref-mdcg-2020-6\">MDCG 2020-6\u003C/a> represents an interpretation by the MDCG. However, in\n  practice, you can expect most notified bodies to align with the MDCG interpretation.\n\u003C/p>\n\u003Cp>\n  According to \u003Ca href=\"#ref-mdcg-2020-6\">MDCG 2020-6\u003C/a>, therefore, manufacturers of legacy\n  devices must provide clinical data from additional sources beyond complaints and vigilance data.\n  The question that now arises is: which additional data, and from which sources?\n\u003C/p>\n\u003Cp>\n  As is often the case, neither the \u003Ca href=\"#ref-mdr\">MDR\u003C/a> nor the MDCG guidance can tell you\n  exactly which type of data constitutes sufficient clinical evidence for your specific device. This\n  is not due to a lack of willingness, but because too many parameters influence the choice and\n  adequacy of data—device type, clinical context, risk classification, and more. For this reason,\n  the regulations and guidances can only define the minimum requirements—that is, what is clearly\n  \u003Cem>not\u003C/em> sufficient. This is also precisely what\n  \u003Ca href=\"#ref-mdcg-2020-6\">MDCG 2020-6\u003C/a> does for Class IIb implantable and Class III devices.\n\u003C/p>\n\u003Cp>\n  According to \u003Ca href=\"#ref-mdcg-2020-6\">MDCG 2020-6\u003C/a>, Class IIb implantable and Class III\n  devices that do \u003Cem>not\u003C/em> qualify as MDCG–WET cannot rely solely on \"low level\" clinical data\n  to demonstrate conformity with the General Safety and Performance Requirement (GSPR). Instead,\n  these devices must be supported by what the MDCG calls “Rank 1 to 4” data. This includes:\n\u003C/p>\n\u003Col>\n  \u003Cli>\n    \u003Cp>\n      High quality clinical investigations covering all device variants, indications, patient\n      populations, duration of treatment effect, etc\n    \u003C/p>\n  \u003C/li>\n  \u003Cli>\u003Cp>High quality clinical investigations with justifiable gaps\u003C/p>\u003C/li>\n  \u003Cli>\u003Cp>High quality clinical data collection systems such as registries\u003C/p>\u003C/li>\n  \u003Cli>\n    \u003Cp>\n      Outcomes from studies with potential methodological flaws but where data can still be\n      quantified and acceptability justified\u003Ca\n        href=\"#fn4\"\n        class=\"footnote-ref\"\n        id=\"fnref4\"\n        role=\"doc-noteref\"\n        >\u003Csup>4\u003C/sup>\u003C/a\n      >.\n    \u003C/p>\n  \u003C/li>\n\u003C/ol>\n\u003Cfigure>\n  \u003Cimg src=\"/guides/well-established-technology/figure-2.svg\" />\n  \u003Cdiv id=\"fig-mdcg-wet\">\u003C/div>\n  \u003Cfigcaption>\n    Figure 2: Class IIb implantable and Class III devices that qualify as MDCG–WET and may\n    demonstrate conformity with the relevant s without relying on Rank 1–4 evidence. The figure also\n    illustrates that, according to \u003Ca href=\"#ref-mdcg-2020-6\">MDCG 2020-6\u003C/a>, the MDR–WET group is\n    a subset of the MDCG–WET group.\n  \u003C/figcaption>\n\u003C/figure>\n\u003Cp>\n  Note that the requirement that Class IIb implantable and Class III devices which do not qualify as\n  MDCG–WET must be supported by Rank 1–4 clinical evidence is not specified in the regulation itself\n  but is introduced in the \u003Ca href=\"#ref-mdcg-2020-6\">MDCG 2020-6\u003C/a> guidance as a form of \"best\n  practice\"—and, indeed, one that most notified bodies are likely to follow. It is also important to\n  emphasize that this requirement does not mean all clinical evidence for a device must come from\n  the top-ranked sources and it does not exclude the use of lower-ranked evidence to support or\n  complement a submission.\n\u003C/p>\n\u003Cp>\n  In a nutshell, Figure \u003Ca href=\"#fig-mdcg-wet\">2\u003C/a>, the core benefit of demonstrating MDCG–WET\n  status is that, for Class IIb implantable and Class III devices, this strategy may open the door\n  to basing the demonstration of conformity on lower-level clinical data—such as Rank 5 (data from\n  equivalent devices), Rank 7 (complaint and vigilance data), or Rank 8 (proactive post-market\n  surveillance data)—even though reliance on such levels of evidence is typically accepted only for\n  lower-risk device classes.\n\u003C/p>\n\u003Cp>\n  It is important to emphasize that while \u003Ca href=\"#ref-mdcg-2020-6\">MDCG 2020-6\u003C/a> acknowledges\n  the use of supporting evidence such as clinical data from similar devices (Rank 6), compliance\n  with non-clinical elements of common specifications (Rank 10), and other forms of non-clinical\n  data—including preclinical studies, simulations, and engineering data (Ranks 11 and 12)—it does\n  not suggest that conformity for MDCG–WET devices can be demonstrated on the basis of these sources\n  alone. On the contrary, it explicitly states that, in line with Article 61(1) of the\n  \u003Ca href=\"#ref-mdr\">MDR\u003C/a>, the demonstration of conformity with the GSPRs must be based on\n  clinical data generated with the device under evaluation or an equivalent device.\n\u003C/p>\n\u003Cp>\n  For devices in risk classes lower than Class IIb implantable and Class III, the benefit of\n  demonstrating MDCG–WET status becomes less pronounced. It is important to highlight that Article\n  61(1) of the \u003Ca href=\"#ref-mdr\">MDR\u003C/a> simply requires that conformity with the relevant GSPRs be\n  demonstrated on the basis of sufficient clinical evidence—leaving it to manufacturers to justify\n  what constitutes “sufficient,” in light of the state of the art in medicine. In general, the\n  \u003Ca href=\"#ref-mdr\">MDR\u003C/a> does not prohibit the use of lower-ranked evidence to support a\n  demonstration of conformity, provided that the approach is adequately justified. Similarly, the\n  MDR allows cumulative approaches to clinical evidence. In fact, clinical validation is inherently\n  cumulative: it builds on preclinical data and information from similar devices, gradually\n  progressing toward a full demonstration of conformity using multiple sources of evidence. The\n  lower the device’s risk class, the more likely notified bodies are to accept flexible, risk-based\n  approaches.\n\u003C/p>\n\u003Ch2 class=\"unnumbered\" id=\"references\">References\u003C/h2>\n\u003Cul>\n  \u003Cli>\n    \u003Cdiv id=\"ref-aimdd\">\u003C/div>\n    \u003Cp>\n      \u003Cstrong>AIMDD\u003C/strong> — Council Directive 90/385/EEC of 20 June 1990 on the approximation of\n      the laws of the Member States relating to active implantable medical devices (AIMDD). Council\n      of the European Communities, 1990\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-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-medical-background-sota\">\u003C/div>\n    \u003Cp>\n      \u003Cstrong>Medical Background SOTA\u003C/strong> — Ho to conductd medical background SOTA analyses.\n      4BetterDevices GmbH, 2025\n    \u003C/p>\n  \u003C/li>\n  \u003Cli>\n    \u003Cdiv id=\"ref-post-market-searches\">\u003C/div>\n    \u003Cp>\n      \u003Cstrong>POST-MARKET SEARCHES\u003C/strong> — How to conduct post-market searches. 4BetterDevices\n      GmbH, 2025\n    \u003C/p>\n  \u003C/li>\n  \u003Cli>\n    \u003Cdiv id=\"ref-surveys\">\u003C/div>\n    \u003Cp>\n      \u003Cstrong>SURVEYS\u003C/strong> — When are surveys clinical investigations?. 4BetterDevices GmbH,\n      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        See our guide on \u003Ca href=\"#ref-medical-background-sota\">Medical Background SOTA\u003C/a>.\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>Guide coming soon.\u003Ca href=\"#fnref2\" class=\"footnote-back\" role=\"doc-backlink\">↩︎\u003C/a>\u003C/p>\n    \u003C/li>\n    \u003Cli id=\"fn3\">\n      \u003Cp>\n        See our guide on \u003Ca href=\"#ref-post-market-searches\">POST-MARKET SEARCHES\u003C/a>.\u003Ca\n          href=\"#fnref3\"\n          class=\"footnote-back\"\n          role=\"doc-backlink\"\n          >↩︎\u003C/a\n        >\n      \u003C/p>\n    \u003C/li>\n    \u003Cli id=\"fn4\">\n      \u003Cp>\n        For more on Rank 4 evidence—specifically, high-quality surveys—see our guide\n        \u003Ca href=\"#ref-surveys\">SURVEYS\u003C/a>.\u003Ca\n          href=\"#fnref4\"\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",1792608381979]