{"id":15397,"date":"2020-08-20T12:03:44","date_gmt":"2020-08-20T10:03:44","guid":{"rendered":"https:\/\/www.thema-med.com\/?p=15397"},"modified":"2020-08-20T12:03:44","modified_gmt":"2020-08-20T10:03:44","slug":"main-chianges-provided-for-in-the-ivdr-2017-746","status":"publish","type":"post","link":"https:\/\/www.thema-med.com\/en\/2020\/08\/20\/main-chianges-provided-for-in-the-ivdr-2017-746\/","title":{"rendered":"What are the main changes provided for in the Regulation on in Vitro Diagnostic Medical Devices IVDR (EU) 2017\/746?"},"content":{"rendered":"\n<p>Manufacturers of in vitro diagnostic medical devices must face <strong>important news <\/strong>provided for in the Regulation on in Vitro Diagnostic Medical Devices <strong>IVDR<\/strong> <strong>(EU) 2017\/746<\/strong>, for example:<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li><strong>Expansion\nof product scope. <\/strong>The scope of the IVDs is extended to include\ndevices manufactured for use within a single healthcare institution among high-risk\ndevices. For example, diagnostic services, genetic tests and other tests which\nprovide information on the predisposition of patients to develop a disease or\non sensitivity to medical therapy. <\/li><\/ul>\n\n\n\n<ul class=\"wp-block-list\"><li><strong>Reclassification\nof devices according to the risk. <\/strong>The new Regulation IVDR 2017\/746 provides specific rules to\ncorrectly classify IVDs according to their degree of risk. Risk classes range\nfrom Class A for low-risk devices to Class D for high-risk devices.<strong><\/strong><\/li><\/ul>\n\n\n\n<ul class=\"wp-block-list\"><li><strong>More rigorous documentation. <\/strong>The IVDR provides more detailed content for technical documentation; moreover, Manufacturers must collect and store post-market clinical data for continuous assessment of potential safety risks.<\/li><\/ul>\n\n\n\n<ul class=\"wp-block-list\"><li><strong>Identification of a \u201cqualified person\u201d. <\/strong>In their company, Manufacturers must appoint\nat least one Responsible Person for compliance with requirements of the new\nIVDR. The company must also document the specific qualifications of this person\naccording to the required tasks. <strong><\/strong><\/li><\/ul>\n\n\n\n<ul class=\"wp-block-list\"><li><strong>More rigorous surveillance by Notified\nBodies <\/strong>to reduce risks\nderiving from unsafe devices. The new classification of medical devices, according\nto their degree of risk, will require the intervention of the Notified Body for\nproduct acceptance. Nearly the 90% of IVDs, for which the \u201cself-certification\u201d\nmodality is currently in place, shall be re-certified according to the IVDR\nRegulation. For the first time, most Manufacturers shall relate to Notified\nBodies in a more rigorous field. to demonstrate the conformity of a device,\nindeed, the IVDR provides for stricter requirements and Manufacturers shall\nproduce more information for the technical documentation. <strong><\/strong><\/li><\/ul>\n\n\n\n<ul class=\"wp-block-list\"><li><strong>Implementation of the Unique Device\nIdentification (UDI) <\/strong>for a\nbetter traceability. <strong><\/strong><\/li><\/ul>\n\n\n\n<ul class=\"wp-block-list\"><li><strong>Performances evaluation <\/strong>to demonstrate conformity according to the IVDR. Manufacturers shall re-evaluate their IVDR devices following the new prescriptions. The Post-Market Performance Follow-up (PMPF) should be prepared. It is considered a continuous evaluation process of performances in order to update them during the entire life cycle of the device. The performances evaluation is a continuous process through which data are evaluated and analysed to demonstrate scientific validity, analytic and clinical performances.<\/li><\/ul>\n\n\n\n<p><strong><a href=\"https:\/\/www.thema-med.com\/en\/services\/\">Discover the strategic-regulatory consultancy services Thema<\/a><\/strong><\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>Are you a Manufacturer of in vitro Diagnostic Medical Devices?<\/strong><\/h2>\n\n\n\n<p><strong>Fill out the form!<\/strong><\/p>\n\n\n\n<p>You will receive our White Paper directly on your inbox: a <strong>valuable help<\/strong> to understand the necessary actions to be taken to adapt to the IVDR and to be able <strong>to market your IVDR devices throughout Europe<\/strong>.<\/p>\n\n\n\n<div class=\"wpcf7 no-js\" id=\"wpcf7-f17991-o1\" lang=\"en-US\" dir=\"ltr\" data-wpcf7-id=\"17991\">\n<div class=\"screen-reader-response\"><p role=\"status\" aria-live=\"polite\" aria-atomic=\"true\"><\/p> 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\/><\/span>\n\t\t\t<\/p>\n\t\t<\/td>\n\t<\/tr>\n\t<tr>\n\t\t<td>\n\t\t\t<p>Company\n\t\t\t<\/p>\n\t\t<\/td>\n\t\t<td>\n\t\t\t<p><span class=\"wpcf7-form-control-wrap\" data-name=\"azienda\"><input size=\"40\" maxlength=\"400\" class=\"wpcf7-form-control wpcf7-text wpcf7-validates-as-required\" aria-required=\"true\" aria-invalid=\"false\" value=\"\" type=\"text\" name=\"azienda\" \/><\/span>\n\t\t\t<\/p>\n\t\t<\/td>\n\t<\/tr>\n\t<tr>\n\t\t<td>\n\t\t\t<p>Country of your company\n\t\t\t<\/p>\n\t\t<\/td>\n\t\t<td>\n\t\t\t<p><span class=\"wpcf7-form-control-wrap\" data-name=\"Country\"><select class=\"wpcf7-form-control wpcf7-select wpcf7-validates-as-required\" aria-required=\"true\" aria-invalid=\"false\" name=\"Country\"><option value=\"\">&#8212;Please choose an option&#8212;<\/option><option value=\"Afghanistan\">Afghanistan<\/option><option value=\"Albania\">Albania<\/option><option value=\"Algeria\">Algeria<\/option><option value=\"Angola\">Angola<\/option><option 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value=\"Canada\">Canada<\/option><option value=\"Central African Republic\">Central African Republic<\/option><option value=\"Chad\">Chad<\/option><option value=\"Chile\">Chile<\/option><option value=\"China\">China<\/option><option value=\"Colombia\">Colombia<\/option><option value=\"Comoros\">Comoros<\/option><option value=\"Costa Rica\">Costa Rica<\/option><option value=\"C\u00f4te d\u2019Ivoire\">C\u00f4te d\u2019Ivoire<\/option><option value=\"Croatia\">Croatia<\/option><option value=\"Cuba\">Cuba<\/option><option value=\"Cyprus\">Cyprus<\/option><option value=\"Czech Republic\">Czech Republic<\/option><option value=\"Denmark\">Denmark<\/option><option value=\"Dominica\">Dominica<\/option><option value=\"Dominican Republic\">Dominican Republic<\/option><option value=\"Ecuador\">Ecuador<\/option><option value=\"Egypt\">Egypt<\/option><option value=\"El Salvador\">El Salvador<\/option><option value=\"Equatorial Guinea\">Equatorial Guinea<\/option><option value=\"Eritrea\">Eritrea<\/option><option value=\"Estonia\">Estonia<\/option><option value=\"Eswatini\">Eswatini<\/option><option value=\"Ethiopia\">Ethiopia<\/option><option value=\"Finland\">Finland<\/option><option value=\"France\">France<\/option><option value=\"Georgia\">Georgia<\/option><option value=\"Germany\">Germany<\/option><option value=\"Ghana\">Ghana<\/option><option value=\"Greece\">Greece<\/option><option value=\"Grenada\">Grenada<\/option><option value=\"Guatemala\">Guatemala<\/option><option value=\"Guinea\">Guinea<\/option><option value=\"Guyana\">Guyana<\/option><option value=\"Haiti\">Haiti<\/option><option value=\"Honduras\">Honduras<\/option><option value=\"Hungary\">Hungary<\/option><option value=\"Iceland\">Iceland<\/option><option value=\"India\">India<\/option><option value=\"Indonesia\">Indonesia<\/option><option value=\"Iran\">Iran<\/option><option value=\"Iraq\">Iraq<\/option><option value=\"Ireland\">Ireland<\/option><option value=\"Israel\">Israel<\/option><option value=\"Italy\">Italy<\/option><option value=\"Jamaica\">Jamaica<\/option><option value=\"Japan\">Japan<\/option><option value=\"Jordan\">Jordan<\/option><option value=\"Kazakhstan\">Kazakhstan<\/option><option value=\"Kenya\">Kenya<\/option><option value=\"Kiribati\">Kiribati<\/option><option value=\"Korea, North\">Korea, North<\/option><option value=\"Korea, South\">Korea, South<\/option><option value=\"Kosovo\">Kosovo<\/option><option value=\"Kuwait\">Kuwait<\/option><option value=\"Kyrgyzstan\">Kyrgyzstan<\/option><option value=\"Laos\">Laos<\/option><option value=\"Latvia\">Latvia<\/option><option value=\"Lebanon\">Lebanon<\/option><option value=\"Lesotho\">Lesotho<\/option><option value=\"Liberia\">Liberia<\/option><option value=\"Libya\">Libya<\/option><option value=\"Liechtenstein\">Liechtenstein<\/option><option value=\"Lithuania\">Lithuania<\/option><option value=\"Luxembourg\">Luxembourg<\/option><option value=\"Madagascar\">Madagascar<\/option><option value=\"Malawi\">Malawi<\/option><option value=\"Malaysia\">Malaysia<\/option><option value=\"Maldives\">Maldives<\/option><option value=\"Mali\">Mali<\/option><option value=\"Malta\">Malta<\/option><option value=\"Mauritania\">Mauritania<\/option><option value=\"Mauritius\">Mauritius<\/option><option value=\"Mexico\">Mexico<\/option><option value=\"Moldova\">Moldova<\/option><option value=\"Monaco\">Monaco<\/option><option value=\"Mongolia\">Mongolia<\/option><option value=\"Montenegro\">Montenegro<\/option><option value=\"Morocco\">Morocco<\/option><option value=\"Mozambique\">Mozambique<\/option><option value=\"Myanmar (Burma)\">Myanmar (Burma)<\/option><option value=\"Namibia\">Namibia<\/option><option value=\"Nauru\">Nauru<\/option><option value=\"Nepal\">Nepal<\/option><option value=\"Netherlands\">Netherlands<\/option><option value=\"New Zealand\">New Zealand<\/option><option value=\"Nicaragua\">Nicaragua<\/option><option 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value=\"Seychelles\">Seychelles<\/option><option value=\"Sierra Leone\">Sierra Leone<\/option><option value=\"Singapore\">Singapore<\/option><option value=\"Slovakia\">Slovakia<\/option><option value=\"Slovenia\">Slovenia<\/option><option value=\"Somalia\">Somalia<\/option><option value=\"South Africa\">South Africa<\/option><option value=\"Spain\">Spain<\/option><option value=\"Sri Lanka\">Sri Lanka<\/option><option value=\"Sudan\">Sudan<\/option><option value=\"Sudan, South\">Sudan, South<\/option><option value=\"Suriname\">Suriname<\/option><option value=\"Sweden\">Sweden<\/option><option value=\"Switzerland\">Switzerland<\/option><option value=\"Syria\">Syria<\/option><option value=\"Taiwan\">Taiwan<\/option><option value=\"Tajikistan\">Tajikistan<\/option><option value=\"Tanzania\">Tanzania<\/option><option value=\"Thailand\">Thailand<\/option><option value=\"The Gambia\">The Gambia<\/option><option value=\"Togo\">Togo<\/option><option value=\"Tonga\">Tonga<\/option><option value=\"Tunisia\">Tunisia<\/option><option value=\"Turkey\">Turkey<\/option><option value=\"Turkmenistan\">Turkmenistan<\/option><option value=\"Uganda\">Uganda<\/option><option value=\"Ukraine\">Ukraine<\/option><option value=\"United Arab Emirates\">United Arab Emirates<\/option><option value=\"United Kingdom\">United Kingdom<\/option><option value=\"United States\">United States<\/option><option value=\"Uruguay\">Uruguay<\/option><option value=\"Uzbekistan\">Uzbekistan<\/option><option value=\"Vatican City\">Vatican City<\/option><option value=\"Venezuela\">Venezuela<\/option><option value=\"Vietnam\">Vietnam<\/option><option value=\"Yemen\">Yemen<\/option><option value=\"Zambia\">Zambia<\/option><option value=\"Zimbabwe\">Zimbabwe<\/option><option value=\"Other\">Other<\/option><\/select><\/span>\n\t\t\t<\/p>\n\t\t<\/td>\n\t<\/tr>\n\t<tr>\n\t\t<td>\n\t\t\t<p>Role\n\t\t\t<\/p>\n\t\t<\/td>\n\t\t<td>\n\t\t\t<p><span class=\"wpcf7-form-control-wrap\" data-name=\"ruolo\"><select class=\"wpcf7-form-control wpcf7-select wpcf7-validates-as-required\" aria-required=\"true\" aria-invalid=\"false\" name=\"ruolo\"><option value=\"\">&#8212;Please choose an option&#8212;<\/option><option value=\"Purchasing\">Purchasing<\/option><option value=\"Sales\">Sales<\/option><option value=\"Marketing\">Marketing<\/option><option value=\"Administration\">Administration<\/option><option value=\"QA\/RA\">QA\/RA<\/option><option value=\"Management\">Management<\/option><option value=\"R &amp; D\">R &amp; D<\/option><option value=\"Other\">Other<\/option><\/select><\/span>\n\t\t\t<\/p>\n\t\t<\/td>\n\t<\/tr>\n\t<tr>\n\t\t<td>\n\t\t\t<p>Email\n\t\t\t<\/p>\n\t\t<\/td>\n\t\t<td>\n\t\t\t<p><span class=\"wpcf7-form-control-wrap\" data-name=\"your-email\"><input size=\"40\" maxlength=\"400\" class=\"wpcf7-form-control wpcf7-email wpcf7-validates-as-required wpcf7-text wpcf7-validates-as-email\" aria-required=\"true\" aria-invalid=\"false\" value=\"\" type=\"email\" name=\"your-email\" 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Lgs. 101\/2018, I agree to receive the CONTENT referred to in question and receive the periodic NEWSLETTER INFORMATION Thema S.r.l<br \/>\n<a href=\"https:\/\/www.thema-med.com\/en\/newsletter-information\/ \">Information concerning the processing of personal data<\/a>\n\t\t\t\t\t\t<\/p>\n\t\t\t\t\t<\/td>\n\t\t\t\t<\/tr>\n\t\t\t<\/table>\n\t\t<\/td>\n\t<\/tr>\n\t<tr>\n\t\t<td>\n\t\t\t<p>&nbsp;\n\t\t\t<\/p>\n\t\t<\/td>\n\t\t<td>\n\t\t\t<p><input class=\"wpcf7-form-control wpcf7-submit has-spinner\" type=\"submit\" value=\"Download the Whitepaper\" \/>\n\t\t\t<\/p>\n\t\t<\/td>\n\t<\/tr>\n<\/table><div class=\"fusion-alert alert custom alert-custom fusion-alert-center wpcf7-response-output fusion-alert-capitalize awb-alert-native-link-color\" style=\"--awb-border-top-left-radius:0px;--awb-border-top-right-radius:0px;--awb-border-bottom-left-radius:0px;--awb-border-bottom-right-radius:0px;\" role=\"alert\"><div class=\"fusion-alert-content-wrapper\"><span 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