{"id":6625,"date":"2023-02-07T10:42:05","date_gmt":"2023-02-07T16:42:05","guid":{"rendered":"https:\/\/casusconsulting.com\/?p=6625"},"modified":"2023-08-16T16:56:16","modified_gmt":"2023-08-16T21:56:16","slug":"frequently-asked-questions","status":"publish","type":"post","link":"https:\/\/casusconsulting.com\/frequently-asked-questions\/","title":{"rendered":"Frequently Asked Questions"},"content":{"rendered":"\n<div style=\"height:65px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<h3 class=\"wp-block-heading\">Frequently Asked Questions<\/h3>\n\n\n\n<div style=\"height:40px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n<div class=\"wp-block-ub-content-filter\" id=\"ub-content-filter-ef0a5257-a317-49eb-9f7f-7f38a93d79b5\" data-currentSelection=\"[[false,false,false,false],[false,false,false,false,false,false,false,false]]\" data-initiallyShowAll=\"true\" data-matchingOption=\"matchAll\"><div class=\"ub-content-filter-category\"\n        data-canUseMultiple=\"true\">\n        <div class=\"ub-content-filter-category-name\">Market<\/div><div data-tagIsSelected=\"false\" data-categoryNumber=\"0\"\n            data-filterNumber=\"0\"  class=\"ub-content-filter-tag\">Europe<\/div><div data-tagIsSelected=\"false\" data-categoryNumber=\"0\"\n            data-filterNumber=\"1\"  class=\"ub-content-filter-tag\">United Kingdom<\/div><div data-tagIsSelected=\"false\" data-categoryNumber=\"0\"\n            data-filterNumber=\"2\"  class=\"ub-content-filter-tag\">Switzerland<\/div><div data-tagIsSelected=\"false\" data-categoryNumber=\"0\"\n            data-filterNumber=\"3\"  class=\"ub-content-filter-tag\">All<\/div><\/div><div class=\"ub-content-filter-category\"\n        data-canUseMultiple=\"true\">\n        <div class=\"ub-content-filter-category-name\">Category<\/div><div data-tagIsSelected=\"false\" data-categoryNumber=\"1\"\n            data-filterNumber=\"0\"  class=\"ub-content-filter-tag\">Labeling<\/div><div data-tagIsSelected=\"false\" data-categoryNumber=\"1\"\n            data-filterNumber=\"1\"  class=\"ub-content-filter-tag\">Transfer<\/div><div data-tagIsSelected=\"false\" data-categoryNumber=\"1\"\n            data-filterNumber=\"2\"  class=\"ub-content-filter-tag\">Importation\/Distribution<\/div><div data-tagIsSelected=\"false\" data-categoryNumber=\"1\"\n            data-filterNumber=\"3\"  class=\"ub-content-filter-tag\">PRRC<\/div><div data-tagIsSelected=\"false\" data-categoryNumber=\"1\"\n            data-filterNumber=\"4\"  class=\"ub-content-filter-tag\">In-Country Representation<\/div><div data-tagIsSelected=\"false\" data-categoryNumber=\"1\"\n            data-filterNumber=\"5\"  class=\"ub-content-filter-tag\">Classification<\/div><div data-tagIsSelected=\"false\" data-categoryNumber=\"1\"\n            data-filterNumber=\"6\"  class=\"ub-content-filter-tag\">CER<\/div><div data-tagIsSelected=\"false\" data-categoryNumber=\"1\"\n            data-filterNumber=\"7\"  class=\"ub-content-filter-tag\">Translation<\/div><\/div>\n<div class=\"ub-content-filter-panel\" style=\"\" data-selectedFilters=\"[[true,false,false,true],[false,false,false,false,false,false,true,false]]\" id=\"ub-content-filter-entry-block-\">\n\n<div style=\"height:25px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n<div class=\"wp-block-ub-content-toggle\" id=\"ub-content-toggle-daf2b3bb-b0dc-4b1f-af24-c664ed0e8879\" data-showonlyone=\"true\" data-mobilecollapse=\"false\" data-desktopcollapse=\"false\">\n<div class=\"wp-block-ub-content-toggle-accordion\" id=\"ub-content-toggle-panel-block-\">\n                <div class=\"wp-block-ub-content-toggle-accordion-title-wrap\"\" aria-controls=\"ub-content-toggle-panel-0-daf2b3bb-b0dc-4b1f-af24-c664ed0e8879\" tabindex=\"0\">\n                    <p class=\"wp-block-ub-content-toggle-accordion-title ub-content-toggle-title-daf2b3bb-b0dc-4b1f-af24-c664ed0e8879\"><strong>How often should a Clinical Evaluation Report (CER) be updated?<\/strong><\/p><div class=\"wp-block-ub-content-toggle-accordion-toggle-wrap right\"><span class=\"wp-block-ub-content-toggle-accordion-state-indicator wp-block-ub-chevron-down\"><\/span>\n                    <\/div><\/div><div role=\"region\" aria-expanded=\"false\" class=\"wp-block-ub-content-toggle-accordion-content-wrap ub-hide\" id=\"ub-content-toggle-panel-0-daf2b3bb-b0dc-4b1f-af24-c664ed0e8879\">\n\n<p class=\"has-black-color has-text-color\">The MDR defines clinical evaluation as the \u201csystematic and planned process to <em>continuously<\/em> generate, collect, analyse and assess the clinical data.\u201d And that manufacturers shall \u201c<em>continuously<\/em> conduct and document a clinical evaluation.\u201d<\/p>\n\n\n\n<p class=\"has-black-color has-text-color\"><strong>The expectations from regulatory authorities and notified bodies are that:<\/strong><\/p>\n\n\n\n<ul class=\"has-black-color has-text-color\">\n<li>Class I device CERs should be updated when necessary (as new evidence becomes known, which may impact the clinical evaluation); however, the best practice is to update it at least every two-to-five years, depending on risk levels<\/li>\n<\/ul>\n\n\n\n<ul class=\"has-black-color has-text-color\">\n<li>Class IIa device CERs should be updated at least every two years, or earlier when necessary<\/li>\n<\/ul>\n\n\n\n<ul class=\"has-black-color has-text-color\">\n<li>Class IIb and III device CERs should be updated at least annually, or earlier when necessary<\/li>\n<\/ul>\n\n\n\n<p class=\"has-black-color has-text-color\">The above dates are not explicitly stated in the regulation. Instead, the regulation simply states that the CER should be updated throughout the life cycle of the device, i.e., through the safe and effective use period for the device, as was defined by the manufacturer in the device documentation.<\/p>\n\n\n\n<p class=\"has-black-color has-text-color\"><strong>So then how do manufacturers determine the appropriate timeframes to update the CER?<\/strong><\/p>\n\n\n\n<p class=\"has-black-color has-text-color\">The short answer is that, at minimum, the CER should be updated on the same schedule as outlined in the device\u2019s Post-Market Surveillance Plan. The reason is that:<\/p>\n\n\n\n<ul class=\"has-black-color has-text-color\">\n<li>The MDR states that post-market surveillance data is clinical data (MDR Art. 2(48))<\/li>\n<\/ul>\n\n\n\n<ul class=\"has-black-color has-text-color\">\n<li>The CER should be updated with any clinical data obtained from Post-Market Clinical Follow-ups* and\/or from the Post-Market Surveillance Plan (MDR Art. 61(11))<\/li>\n<\/ul>\n\n\n\n<ul class=\"has-black-color has-text-color\">\n<li>Post-Market Surveillance data should be used to update the CER (MDR Art. 83(c))<\/li>\n<\/ul>\n\n\n\n<p class=\"has-black-color has-text-color\">Further, a Periodic Safety Update Report (PSUR) is part of Post-Market Surveillance, and those require updates on the following schedule:<\/p>\n\n\n\n<ul class=\"has-black-color has-text-color\">\n<li>Class IIa devices when necessary and at least every two years (MDR Art. 86(1))<\/li>\n<\/ul>\n\n\n\n<ul class=\"has-black-color has-text-color\">\n<li>Class IIb and III devices at least annually (MDR Art. 86(1))<\/li>\n<\/ul>\n\n\n\n<p class=\"has-black-color has-text-color\">Since post-market surveillance data feeds into the CER, the status of the CER should be considered as post-market surveillance data is assessed. Where the post-market data shows potential new risks, this should be investigated and addressed, including in the CER. If the post-market surveillance data continues to show a positive benefit-risk ratio, this should also be noted in the CER.<\/p>\n\n\n\n<p class=\"has-black-color has-text-color\">The requirement for Periodic Safety Update Reports (PSUR) is throughout the device\u2019s lifetime. Where the device is no longer being manufactured, the PSUR is expected to at least include reactive data, e.g., complaints and vigilance. And such information may warrant an update to the CER.<\/p>\n\n\n\n<p class=\"has-black-color has-text-color\">*Where Post-market Clinical Follow-ups (PMCFs) are required, the MDR stipulates that the PMCF evaluation report for Class III and implantable devices shall be updated at least annually (MDR Art. 61(11)(para 2).<\/p>\n\n<\/div><\/div>\n<\/div>\n<\/div>\n\n<div class=\"ub-content-filter-panel\" style=\"\" data-selectedFilters=\"[[true,false,false,true],[true,false,false,false,false,false,false,true]]\" id=\"ub-content-filter-entry-block-\">\n\n<div style=\"height:25px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n<div class=\"wp-block-ub-content-toggle\" id=\"ub-content-toggle-e7f8c1c5-d661-4cd2-a069-a6e585128b17\" data-showonlyone=\"true\" data-mobilecollapse=\"false\" data-desktopcollapse=\"true\">\n<div class=\"wp-block-ub-content-toggle-accordion\" id=\"ub-content-toggle-panel-block-\">\n                <div class=\"wp-block-ub-content-toggle-accordion-title-wrap\"\" aria-controls=\"ub-content-toggle-panel-0-e7f8c1c5-d661-4cd2-a069-a6e585128b17\" tabindex=\"0\">\n                    <p class=\"wp-block-ub-content-toggle-accordion-title ub-content-toggle-title-e7f8c1c5-d661-4cd2-a069-a6e585128b17\"><strong>Does the software interface require translation into the languages in each EU market where the product is being sold?<\/strong><\/p><div class=\"wp-block-ub-content-toggle-accordion-toggle-wrap right\"><span class=\"wp-block-ub-content-toggle-accordion-state-indicator wp-block-ub-chevron-down\"><\/span>\n                    <\/div><\/div><div role=\"region\" aria-expanded=\"false\" class=\"wp-block-ub-content-toggle-accordion-content-wrap ub-hide\" id=\"ub-content-toggle-panel-0-e7f8c1c5-d661-4cd2-a069-a6e585128b17\">\n\n<p class=\"has-black-color has-text-color\">The&nbsp;MDR&nbsp;and&nbsp;IVDR&nbsp;state that it is the manufacturer\u2019s responsibility to translate \u2018Information Supplied with the Device\u2019, as defined by Section 23 of Annex I. This is stipulated per:<\/p>\n\n\n\n<p class=\"has-black-color has-text-color\">MDR Art.10(11): <em>Manufacturers shall ensure that the device is accompanied by the information set out in Section 23 of Annex I in an official Union language(s) determined by the Member State in which the device is made available to the user or patient. The particulars on the label shall be indelible, easily legible and clearly comprehensible to the intended user or patient.<\/em><\/p>\n\n\n\n<p class=\"has-black-color has-text-color\">The question then becomes: Is the software user interface considered information supplied with the device?<\/p>\n\n\n\n<p class=\"has-black-color has-text-color\">The MDR and IVDR do not explicitly identify the software interface as such. Further, to date, there is no official published guidance advising one way or another.<\/p>\n\n\n\n<p class=\"has-black-color has-text-color\">While many notified bodies and regulatory authorities do consider the software interface as \u2018information supplied with the device\u2019, there is no single centralized position published. Therefore, manufacturers, Notified Bodies and Competent Authorities may each have differing interpretations.<\/p>\n\n\n\n<p class=\"has-black-color has-text-color\">Manufacturers would ideally take the following into consideration:<\/p>\n\n\n\n<ul class=\"has-black-color has-text-color\">\n<li>Each Competent Authority has established its own translation requirements for medical devices and IVDs. The requirements may depend on if the device is for professional or layperson use. A full overview of translation requirements per market can be found on our website: <a href=\"https:\/\/casusconsulting.com\/eu-language-translation-requirements\/#tool\" target=\"_blank\" rel=\"noreferrer noopener\"><strong>HERE<\/strong><\/a>\n<ul>\n<li>Can you demonstrate you have met the Competent Authority\u2019s translation requirements if the user interface is not translated into its national language?<\/li>\n<\/ul>\n<\/li>\n\n\n\n<li>The MDR\/IVDR Annex I, Section 23(1) states: \u201c<em>Each device shall be accompanied by the information needed to identify the device and its manufacturer, and by any safety and performance information relevant to the user.<\/em>\u201d\n<ul class=\"has-black-color has-text-color\">\n<li>Is anything within the software interface potentially considered \u2018safety and performance information\u2019 that is relevant to the user?<\/li>\n<\/ul>\n<\/li>\n\n\n\n<li>The MDR\/IVDR\u2019s General Safety and Performance Requirements (GSPRs) stipulate that manufacturers must \u201c<em>reduce risks as far as possible<\/em>\u201d and \u201c<em>give consideration to the technical knowledge, experience, education, training and use environment, where applicable<\/em>\u201d.\n<ul class=\"has-black-color has-text-color\">\n<li>Can you demonstrate that you have reduced the risks as far as possible if the user interface is not translated into the user\u2019s national language?<\/li>\n\n\n\n<li>Can you demonstrate that you have sufficiently considered the user\u2019s knowledge, experience, and education, if the user interface is not translated into the user\u2019s national language?<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n\n\n\n<p class=\"has-black-color has-text-color\">Generally, if the software interface includes information required to ensure the device is used as intended and\/or information related to the safety and performance, this information should be translated. This is especially important for layperson devices.<\/p>\n\n\n\n<p class=\"has-black-color has-text-color\">If, considering the above, a manufacturer chooses not to translate the software interface, the rationale and justification should be clearly documented in the risk assessment.&nbsp; Where more definitive confirmation is needed, manufacturers should confirm directly with the local Competent Authority if it is required and\/or if an exemption can be granted for their device.<\/p>\n\n<\/div><\/div>\n<\/div>\n<\/div>\n\n<div class=\"ub-content-filter-panel\" style=\"\" data-selectedFilters=\"[[true,false,false,true],[false,true,false,false,true,false,false,false]]\" id=\"ub-content-filter-entry-block-\">\n\n<div style=\"height:25px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n<div class=\"wp-block-ub-content-toggle\" id=\"ub-content-toggle-cfd7d0f9-848a-471f-bbd4-fddbec9a107f\" data-showonlyone=\"true\" data-mobilecollapse=\"false\" data-desktopcollapse=\"false\">\n<div class=\"wp-block-ub-content-toggle-accordion\" id=\"ub-content-toggle-panel-block-\">\n                <div class=\"wp-block-ub-content-toggle-accordion-title-wrap\"\" aria-controls=\"ub-content-toggle-panel-0-cfd7d0f9-848a-471f-bbd4-fddbec9a107f\" tabindex=\"0\">\n                    <p class=\"wp-block-ub-content-toggle-accordion-title ub-content-toggle-title-cfd7d0f9-848a-471f-bbd4-fddbec9a107f\"><strong>What is the process to transfer your EU Authorized Representative?<\/strong><\/p><div class=\"wp-block-ub-content-toggle-accordion-toggle-wrap right\"><span class=\"wp-block-ub-content-toggle-accordion-state-indicator wp-block-ub-chevron-down\"><\/span>\n                    <\/div><\/div><div role=\"region\" aria-expanded=\"false\" class=\"wp-block-ub-content-toggle-accordion-content-wrap ub-hide\" id=\"ub-content-toggle-panel-0-cfd7d0f9-848a-471f-bbd4-fddbec9a107f\">\n\n<p class=\"has-black-color has-text-color\">An overview of the process to transfer your EU Authorized Representative (EU AR) can be found in our Knowledge Center: <strong><a rel=\"noreferrer noopener\" href=\"https:\/\/casusconsulting.com\/eu-authorized-representative-transfer-steps\/\" data-type=\"URL\" data-id=\"https:\/\/casusconsulting.com\/eu-authorized-representative-transfer-steps\/\" target=\"_blank\">STEPS AND TIMING TO TRANSFER YOUR EU AR<\/a><\/strong><\/p>\n\n<\/div><\/div>\n<\/div>\n<\/div>\n\n<div class=\"ub-content-filter-panel\" style=\"\" data-selectedFilters=\"[[false,true,false,true],[false,true,false,false,true,false,false,false]]\" id=\"ub-content-filter-entry-block-\">\n\n<div style=\"height:10px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n<div class=\"wp-block-ub-content-toggle\" id=\"ub-content-toggle-a74c8dad-241a-4c6f-8875-ebfefc3ad426\" data-showonlyone=\"true\" data-mobilecollapse=\"false\" data-desktopcollapse=\"false\">\n<div class=\"wp-block-ub-content-toggle-accordion\" id=\"ub-content-toggle-panel-block-\">\n                <div class=\"wp-block-ub-content-toggle-accordion-title-wrap\"\" aria-controls=\"ub-content-toggle-panel-0-a74c8dad-241a-4c6f-8875-ebfefc3ad426\" tabindex=\"0\">\n                    <p class=\"wp-block-ub-content-toggle-accordion-title ub-content-toggle-title-a74c8dad-241a-4c6f-8875-ebfefc3ad426\"><strong>What is the process to transfer your UK Responsible Person?<\/strong><\/p><div class=\"wp-block-ub-content-toggle-accordion-toggle-wrap right\"><span class=\"wp-block-ub-content-toggle-accordion-state-indicator wp-block-ub-chevron-down\"><\/span>\n                    <\/div><\/div><div role=\"region\" aria-expanded=\"false\" class=\"wp-block-ub-content-toggle-accordion-content-wrap ub-hide\" id=\"ub-content-toggle-panel-0-a74c8dad-241a-4c6f-8875-ebfefc3ad426\">\n\n<p class=\"has-black-color has-text-color\">An overview of the process to transfer your UK Responsible Person (UKRP) can be found in our Knowledge Center: <a rel=\"noreferrer noopener\" href=\"https:\/\/casusconsulting.com\/ukrp_transfer_steps\/\" data-type=\"URL\" data-id=\"https:\/\/casusconsulting.com\/ukrp_transfer_steps\/\" target=\"_blank\"><strong>STEPS AND TIMING TO TRANSFER YOUR UKRP<\/strong><\/a><\/p>\n\n<\/div><\/div>\n<\/div>\n<\/div>\n\n<div class=\"ub-content-filter-panel\" style=\"\" data-selectedFilters=\"[[false,false,true,true],[false,true,false,false,true,false,false,false]]\" id=\"ub-content-filter-entry-block-\">\n\n<div style=\"height:10px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n<div class=\"wp-block-ub-content-toggle\" id=\"ub-content-toggle-e77c34b7-c2b1-40bc-b5e7-37c631130bc4\" data-showonlyone=\"true\" data-mobilecollapse=\"false\" data-desktopcollapse=\"false\">\n<div class=\"wp-block-ub-content-toggle-accordion\" id=\"ub-content-toggle-panel-block-\">\n                <div class=\"wp-block-ub-content-toggle-accordion-title-wrap\"\" aria-controls=\"ub-content-toggle-panel-0-e77c34b7-c2b1-40bc-b5e7-37c631130bc4\" tabindex=\"0\">\n                    <p class=\"wp-block-ub-content-toggle-accordion-title ub-content-toggle-title-e77c34b7-c2b1-40bc-b5e7-37c631130bc4\"><strong>What is the process to transfer your Swiss Authorized Representative?<\/strong><\/p><div class=\"wp-block-ub-content-toggle-accordion-toggle-wrap right\"><span class=\"wp-block-ub-content-toggle-accordion-state-indicator wp-block-ub-chevron-down\"><\/span>\n                    <\/div><\/div><div role=\"region\" aria-expanded=\"false\" class=\"wp-block-ub-content-toggle-accordion-content-wrap ub-hide\" id=\"ub-content-toggle-panel-0-e77c34b7-c2b1-40bc-b5e7-37c631130bc4\">\n\n<p class=\"has-black-color has-text-color\">An overview of the process to transfer your Swiss Authorized Representative (CH-REP) can be found in our Knowledge Center: <strong><a rel=\"noreferrer noopener\" href=\"https:\/\/casusconsulting.com\/ch-swiss-authorized-representative-transfer-steps\/\" data-type=\"URL\" data-id=\"https:\/\/casusconsulting.com\/ch-swiss-authorized-representative-transfer-steps\/\" target=\"_blank\">STEPS AND TIMING TO TRANSFER YOUR CH-REP<\/a><\/strong><\/p>\n\n<\/div><\/div>\n<\/div>\n<\/div>\n\n<div class=\"ub-content-filter-panel\" style=\"\" data-selectedFilters=\"[[true,false,false,true],[false,false,true,false,false,false,false,false]]\" id=\"ub-content-filter-entry-block-\">\n\n<div style=\"height:10px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n<div class=\"wp-block-ub-content-toggle\" id=\"ub-content-toggle-3d24b71d-6c4f-47b8-b96b-550873a5ee57\" data-showonlyone=\"true\" data-mobilecollapse=\"false\" data-desktopcollapse=\"false\">\n<div class=\"wp-block-ub-content-toggle-accordion\" id=\"ub-content-toggle-panel-block-\">\n                <div class=\"wp-block-ub-content-toggle-accordion-title-wrap\"\" aria-controls=\"ub-content-toggle-panel-0-3d24b71d-6c4f-47b8-b96b-550873a5ee57\" tabindex=\"0\">\n                    <p class=\"wp-block-ub-content-toggle-accordion-title ub-content-toggle-title-3d24b71d-6c4f-47b8-b96b-550873a5ee57\"><strong>Am I allowed to donate non-CE Marked medical devices to Europe<\/strong>?<\/p><div class=\"wp-block-ub-content-toggle-accordion-toggle-wrap right\"><span class=\"wp-block-ub-content-toggle-accordion-state-indicator wp-block-ub-chevron-down\"><\/span>\n                    <\/div><\/div><div role=\"region\" aria-expanded=\"false\" class=\"wp-block-ub-content-toggle-accordion-content-wrap ub-hide\" id=\"ub-content-toggle-panel-0-3d24b71d-6c4f-47b8-b96b-550873a5ee57\">\n\n<p class=\"has-black-color has-text-color\">Devices being placed on the market for the first time in the EU must be CE Marked or have been granted a derogation by an EU Competent Authority, whether they are for donation or for sale (see definition of \u2018placed on the market\u2019 in the EU<strong> <\/strong><a href=\"https:\/\/casusconsulting.com\/placing-on-market-eu-uk-switzerland\/#Place_on_Mkt_EU\" target=\"_blank\" rel=\"noreferrer noopener\"><strong>here<\/strong><\/a>). Each EU Competent Authority can only grant a derogation for its specific market, so manufacturers must seek individual derogations for each EU country where they would like to place their product on the market without CE Marking.<\/p>\n\n\n\n<p class=\"has-black-color has-text-color\">Once the device has been placed on the market, it can be further resold or donated.<\/p>\n\n\n\n<p class=\"has-black-color has-text-color\">The MDR and IVDR only apply to medical devices being placed on the market for the first time. The<strong> <\/strong><a href=\"https:\/\/eur-lex.europa.eu\/legal-content\/EN\/TXT\/?uri=uriserv%3AOJ.C_.2022.247.01.0001.01.ENG&amp;toc=OJ%3AC%3A2022%3A247%3ATOC\" target=\"_blank\" rel=\"noreferrer noopener\"><strong>EU Blue Guide 2022<\/strong><\/a> clarifies that second-hand products from third countries placed on the market for the first time must comply with the EU legislation (MDR and IVDR).<\/p>\n\n\n\n<p class=\"has-black-color has-text-color\">There is no medical device legislation that specifically covers devices for resale or reuse, including providing devices second-hand for donation.&nbsp;Therefore, if a device was compliant at the time it was placed on the market, it can be further sold or donated for reuse. That being said, those further resold medical devices are still required to be safe and within their effective use period.<\/p>\n\n<\/div><\/div>\n<\/div>\n<\/div>\n\n<div class=\"ub-content-filter-panel\" style=\"\" data-selectedFilters=\"[[false,false,true,true],[false,false,true,false,false,false,false,false]]\" id=\"ub-content-filter-entry-block-\">\n\n<div style=\"height:10px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n<div class=\"wp-block-ub-content-toggle\" id=\"ub-content-toggle-5c7b94fa-4f2c-4be0-ba6b-f8573f8d6673\" data-showonlyone=\"true\" data-mobilecollapse=\"false\" data-desktopcollapse=\"false\">\n<div class=\"wp-block-ub-content-toggle-accordion\" id=\"ub-content-toggle-panel-block-\">\n                <div class=\"wp-block-ub-content-toggle-accordion-title-wrap\"\" aria-controls=\"ub-content-toggle-panel-0-5c7b94fa-4f2c-4be0-ba6b-f8573f8d6673\" tabindex=\"0\">\n                    <p class=\"wp-block-ub-content-toggle-accordion-title ub-content-toggle-title-5c7b94fa-4f2c-4be0-ba6b-f8573f8d6673\"><strong>Am I allowed to donate non-CE Marked medical devices to Switzerland?<\/strong><\/p><div class=\"wp-block-ub-content-toggle-accordion-toggle-wrap right\"><span class=\"wp-block-ub-content-toggle-accordion-state-indicator wp-block-ub-chevron-down\"><\/span>\n                    <\/div><\/div><div role=\"region\" aria-expanded=\"false\" class=\"wp-block-ub-content-toggle-accordion-content-wrap ub-hide\" id=\"ub-content-toggle-panel-0-5c7b94fa-4f2c-4be0-ba6b-f8573f8d6673\">\n\n<p class=\"has-black-color has-text-color\">Devices being placed on the market for the first time in the Switzerland must meet the requirements of the applicable device Ordinance (<strong><a rel=\"noreferrer noopener\" href=\"https:\/\/www.fedlex.admin.ch\/eli\/cc\/2020\/552\/en\" target=\"_blank\">MedDO<\/a> <\/strong>or&nbsp;<strong><a rel=\"noreferrer noopener\" href=\"https:\/\/www.fedlex.admin.ch\/eli\/oc\/2022\/291\/en\" target=\"_blank\">IvDO<\/a><\/strong>) or have been granted an exemption by Swissmedic, whether they are for donation or for sale (see definition of \u2018placed on the market\u2019 in Switzerland <strong><a rel=\"noreferrer noopener\" href=\"https:\/\/casusconsulting.com\/placing-on-market-eu-uk-switzerland\/#Place_on_Mkt_Swiss\" target=\"_blank\">here<\/a><\/strong>). Information on requesting an exemption from Swissmedic can be found <strong><a href=\"https:\/\/www.swissmedic.ch\/swissmedic\/en\/home\/medical-devices\/market-access\/authorisations-for-non-conforming-medical-devices.html\" target=\"_blank\" rel=\"noreferrer noopener\">here<\/a><\/strong>.<\/p>\n\n\n\n<p class=\"has-black-color has-text-color\">The Swiss Ordinances only apply to medical devices being sold for the first time.&nbsp;And, there is no medical device legislation which specifically covers devices for resale or reuse, including providing devices second-hand for donation.&nbsp;Therefore, if a device was compliant at the time it was placed on the market, it can be further sold or donated for reuse. That being said, those further resold medical devices are still required to be safe and within their effective use period.<\/p>\n\n<\/div><\/div>\n<\/div>\n<\/div>\n\n<div class=\"ub-content-filter-panel\" style=\"\" data-selectedFilters=\"[[false,true,false,true],[false,false,true,false,false,false,false,false]]\" id=\"ub-content-filter-entry-block-\">\n\n<div style=\"height:10px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n<div class=\"wp-block-ub-content-toggle\" id=\"ub-content-toggle-349e25da-2e44-4c81-b2de-5c4f805a0c58\" data-showonlyone=\"true\" data-mobilecollapse=\"false\" data-desktopcollapse=\"false\">\n<div class=\"wp-block-ub-content-toggle-accordion\" id=\"ub-content-toggle-panel-block-\">\n                <div class=\"wp-block-ub-content-toggle-accordion-title-wrap\"\" aria-controls=\"ub-content-toggle-panel-0-349e25da-2e44-4c81-b2de-5c4f805a0c58\" tabindex=\"0\">\n                    <p class=\"wp-block-ub-content-toggle-accordion-title ub-content-toggle-title-349e25da-2e44-4c81-b2de-5c4f805a0c58\"><strong><strong>Am I allowed to donate non-CE Marked\/UKCA Marked medical devices to the UK?<\/strong><\/strong><\/p><div class=\"wp-block-ub-content-toggle-accordion-toggle-wrap right\"><span class=\"wp-block-ub-content-toggle-accordion-state-indicator wp-block-ub-chevron-down\"><\/span>\n                    <\/div><\/div><div role=\"region\" aria-expanded=\"false\" class=\"wp-block-ub-content-toggle-accordion-content-wrap ub-hide\" id=\"ub-content-toggle-panel-0-349e25da-2e44-4c81-b2de-5c4f805a0c58\">\n\n<p class=\"has-black-color has-text-color\">Devices being placed on the market for the first time in the UK must be CE Marked, UKCA marked, or have been granted an exemption by the MHRA, whether they are for donation or for sale (see definition of \u2018placed on the market\u2019 in the UK<strong> <a href=\"https:\/\/casusconsulting.com\/placing-on-market-eu-uk-switzerland\/#Place_on_Mkt_UK\" target=\"_blank\" rel=\"noreferrer noopener\">here<\/a><\/strong>). Information on requesting an exemption from the MRHA can be found <strong><a href=\"https:\/\/www.gov.uk\/guidance\/exemptions-from-devices-regulations-during-the-coronavirus-covid-19-outbreak#exemptions-for-all-other-kind-of-medical-device\" target=\"_blank\" rel=\"noreferrer noopener\">here<\/a><\/strong>.<\/p>\n\n\n\n<p class=\"has-black-color has-text-color\">Once the device has been placed on the market, it can be further resold or donated.<\/p>\n\n\n\n<p class=\"has-black-color has-text-color\">The UK MDR 2002 only applies to medical devices being sold for the first time.&nbsp;And, there is no medical device legislation which specifically covers devices for resale or reuse, including providing devices second-hand for donation.&nbsp;Therefore, if a device was compliant at the time it was placed on the market, it can be further sold or donated for reuse.<\/p>\n\n\n\n<p class=\"has-black-color has-text-color\">That being said, used medical devices are still required to be safe and still need to comply with certain consumer and trade regulations. Further, the supplier of the used products should still provide certain information to the purchaser to demonstrate the safety and efficacy of the device and the device\u2019s service history.&nbsp;<\/p>\n\n\n\n<p class=\"has-black-color has-text-color\">More information about the specific regulations and device safety information that may be applicable is included in section 10.4 of the MHRA\u2019s guidance document: <strong><a href=\"https:\/\/assets.publishing.service.gov.uk\/government\/uploads\/system\/uploads\/attachment_data\/file\/982127\/Managing_medical_devices.pdf\" target=\"_blank\" rel=\"noreferrer noopener\">Managing Medical Devices<\/a><\/strong><\/p>\n\n<\/div><\/div>\n<\/div>\n<\/div>\n\n<div class=\"ub-content-filter-panel\" style=\"\" data-selectedFilters=\"[[true,false,false,true],[false,false,true,false,false,false,false,false]]\" id=\"ub-content-filter-entry-block-\">\n\n<div style=\"height:10px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n<div class=\"wp-block-ub-content-toggle\" id=\"ub-content-toggle-fcebdb7b-a484-4897-b0fc-1eb9f12342d8\" data-showonlyone=\"true\" data-mobilecollapse=\"false\" data-desktopcollapse=\"false\">\n<div class=\"wp-block-ub-content-toggle-accordion\" id=\"ub-content-toggle-panel-block-\">\n                <div class=\"wp-block-ub-content-toggle-accordion-title-wrap\"\" aria-controls=\"ub-content-toggle-panel-0-fcebdb7b-a484-4897-b0fc-1eb9f12342d8\" tabindex=\"0\">\n                    <p class=\"wp-block-ub-content-toggle-accordion-title ub-content-toggle-title-fcebdb7b-a484-4897-b0fc-1eb9f12342d8\"><strong>Can a device with an expired CE certificate be sold in Europe?<\/strong><\/p><div class=\"wp-block-ub-content-toggle-accordion-toggle-wrap right\"><span class=\"wp-block-ub-content-toggle-accordion-state-indicator wp-block-ub-chevron-down\"><\/span>\n                    <\/div><\/div><div role=\"region\" aria-expanded=\"false\" class=\"wp-block-ub-content-toggle-accordion-content-wrap ub-hide\" id=\"ub-content-toggle-panel-0-fcebdb7b-a484-4897-b0fc-1eb9f12342d8\">\n\n<p class=\"has-black-color has-text-color\">The ability to sell a device in the EU with an expired CE certificate depends on the following factors:<\/p>\n\n\n\n<ul class=\"has-black-color has-text-color\">\n<li>The applicable regulation, i.e., if the device is a \u2018legacy\u2019 product (under the MDD\/IVDD\/AIMDD) or certified under the MDR and IVDR; and,<\/li>\n\n\n\n<li>Where in the supply chain the product was when the certificate expired, i.e., if it is being \u2018placed on the market\u2019* or if it is being \u2018made available\u2019.**<\/li>\n<\/ul>\n\n\n\n<p class=\"has-black-color has-text-color\"><strong>\u2018Placed on the market\u2019<\/strong><\/p>\n\n\n\n<p class=\"has-black-color has-text-color\"><strong>Legacy Device (valid MDD\/IVDD\/AIMDD CE Certificate):<\/strong> Legacy devices with an expired CE Certificate are able to be \u2018placed on the market\u2019 through the below transitional deadlines, per <a href=\"https:\/\/eur-lex.europa.eu\/legal-content\/EN\/TXT\/?uri=CELEX%3A32023R0607&amp;qid=1681321656796#d1e291-24-1\" target=\"_blank\" rel=\"noreferrer noopener\"><strong>Regulation 2023\/607<\/strong><\/a>. This regulation came into force on 20 March 2023, automatically extending the validity of CE certificates for legacy devices.<\/p>\n\n\n\n<p class=\"has-black-color has-text-color\">To be eligible for these transition timelines, the device and manufacturer must meet the specific criteria established in the regulation.&nbsp;Read more about the requirements <a href=\"https:\/\/casusconsulting.com\/eu-commission-official-proposal-to-delay-mdr\/\" target=\"_blank\" rel=\"noreferrer noopener\"><strong>here<\/strong><\/a>.<\/p>\n\n\n\n<ul class=\"has-black-color has-text-color\">\n<li>Class I (sterile\/measuring), Class IIa, Class IIb non-implantable \u2013 31 December 2028<\/li>\n\n\n\n<li>Class IIb implantable &amp; Class III \u2013 31 December 2027\n<ul class=\"has-black-color has-text-color\">\n<li>(except sutures, staples, dental fillings, dental braces, tooth crowns, screws, wedges, plates, wires, pins, clips and connectors)<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n\n\n\n<p class=\"has-black-color has-text-color\"><strong>MDR\/IVDR Device: <\/strong>MDR\/IVDR devices with an expired CE Certificate cannot be \u2018placed on the market\u2019 &#8211; the CE certificate must be valid at the time the device is \u2018placed on the market\u2019.<\/p>\n\n\n\n<p class=\"has-black-color has-text-color\"><strong>\u2018Made Available on the Market\u2019<\/strong><\/p>\n\n\n\n<p class=\"has-black-color has-text-color\"><strong>Legacy Device (valid MDD\/IVDD\/AIMDD CE Certificate):<\/strong> Legacy Devices \u2018placed on the market\u2019 in compliance with the amended deadlines and criteria of <strong><a href=\"https:\/\/eur-lex.europa.eu\/legal-content\/EN\/TXT\/?uri=CELEX%3A32023R0607&amp;qid=1681321656796#d1e291-24-1\" target=\"_blank\" rel=\"noreferrer noopener\">Regulation 2023\/607<\/a> <\/strong>may continue to be \u2018made available on the market\u2019 or \u2018put into service\u2019 without any limitation in time\u2019 except the device\u2019s shelf-life or expiry date (see: <a href=\"https:\/\/health.ec.europa.eu\/latest-updates\/rev-1-qa-practical-aspects-related-implementation-regulation-eu-2023607-2023-07-18_en\" target=\"_blank\" rel=\"noreferrer noopener\"><strong>Q&amp;A on practical aspects related to the implementation of Regulation (EU) 2023\/607<\/strong><\/a>).<\/p>\n\n\n\n<p class=\"has-black-color has-text-color\"><strong>MDR\/IVDR Device:&nbsp;<\/strong>MDR\/IVDR devices that were \u2018placed on the market\u2019 in the period where the certificate was valid and was in conformity with all applicable legislation, can further be \u2018made available\u2019 and \u2018put into service\u2019 after the CE certificate expires.<\/p>\n\n\n\n<p class=\"has-black-color has-text-color\"><strong>Definitions<\/strong><\/p>\n\n\n\n<p class=\"has-black-color has-text-color\">*<strong>Placing on the Market (<\/strong>MDR Article 2(28)<strong>)<\/strong>: the first making available of a device, other than an investigational device, on the Union market.<\/p>\n\n\n\n<p class=\"has-black-color has-text-color\">The <a rel=\"noreferrer noopener\" href=\"https:\/\/eur-lex.europa.eu\/legal-content\/EN\/TXT\/?uri=uriserv%3AOJ.C_.2022.247.01.0001.01.ENG&amp;toc=OJ%3AC%3A2022%3A247%3ATOC\" target=\"_blank\"><strong>Blue Guide<\/strong><\/a> further explains that devices that are manufactured (i.e. ready to ship) and have an agreement in place for purchase with a local importer are considered \u2018placed on market\u2019.&nbsp; The Blue Guide further explains that \u2018Any subsequent operation, for instance, from a distributor to distributor or from a distributor to an end-user is defined as making available\u2019.&nbsp;Read more about the definition of \u2018placing a product on the marketing\u2019 in the EU <a rel=\"noreferrer noopener\" href=\"https:\/\/casusconsulting.com\/placing-on-market-eu-uk-switzerland\/\" target=\"_blank\"><strong>here<\/strong><\/a>.<\/p>\n\n\n\n<p class=\"has-black-color has-text-color\">**<strong>Making available on the market <\/strong>(Article 2(27)):<strong> <\/strong>any supply of a device, other than an investigational device, for distribution, consumption or use on the Union market in the course of a commercial activity, whether in return for payment or free of charge.<\/p>\n\n\n\n<p class=\"has-black-color has-text-color\">***<strong>Putting into service (<\/strong>MDR Article 2 (29)): The stage at which a device, other than an investigational device, has been made available to the final user as being ready for use on the Union market for the first time for its intended purpose.<\/p>\n\n<\/div><\/div>\n<\/div>\n<\/div>\n\n<div class=\"ub-content-filter-panel\" style=\"\" data-selectedFilters=\"[[true,false,false,true],[true,false,false,false,true,false,false,false]]\" id=\"ub-content-filter-entry-block-\">\n\n<div style=\"height:10px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n<div class=\"wp-block-ub-content-toggle\" id=\"ub-content-toggle-09e7d3cc-df62-4a92-8123-936f0d60b303\" data-showonlyone=\"true\" data-mobilecollapse=\"false\" data-desktopcollapse=\"false\">\n<div class=\"wp-block-ub-content-toggle-accordion\" id=\"ub-content-toggle-panel-block-\">\n                <div class=\"wp-block-ub-content-toggle-accordion-title-wrap\"\" aria-controls=\"ub-content-toggle-panel-0-09e7d3cc-df62-4a92-8123-936f0d60b303\" tabindex=\"0\">\n                    <p class=\"wp-block-ub-content-toggle-accordion-title ub-content-toggle-title-09e7d3cc-df62-4a92-8123-936f0d60b303\"><strong>Is the EU Authorized Representative required to be on the device labeling?<\/strong><\/p><div class=\"wp-block-ub-content-toggle-accordion-toggle-wrap right\"><span class=\"wp-block-ub-content-toggle-accordion-state-indicator wp-block-ub-chevron-down\"><\/span>\n                    <\/div><\/div><div role=\"region\" aria-expanded=\"false\" class=\"wp-block-ub-content-toggle-accordion-content-wrap ub-hide\" id=\"ub-content-toggle-panel-0-09e7d3cc-df62-4a92-8123-936f0d60b303\">\n\n<p class=\"has-black-color has-text-color\">Yes, the EU Authorized Representative (EU AR) is required to be on the device labeling.<\/p>\n\n\n\n<p class=\"has-black-color has-text-color\">More information about what must be included and where to place the EU AR info can be found in our Knowledge Center: <strong><a href=\"https:\/\/casusconsulting.com\/in-country-representative-labeling-requirements\/\" data-type=\"URL\" data-id=\"https:\/\/casusconsulting.com\/in-country-representative-labeling-requirements\/\">L<\/a><a rel=\"noreferrer noopener\" href=\"https:\/\/casusconsulting.com\/in-country-representative-labeling-requirements\/\" data-type=\"URL\" data-id=\"https:\/\/casusconsulting.com\/in-country-representative-labeling-requirements\/\" target=\"_blank\">ABELING REQUIREMENTS FOR THE EU, UK AND SWITZERLAND IN-COUNTRY REPRESENTATIVE<\/a><\/strong><\/p>\n\n<\/div><\/div>\n<\/div>\n<\/div>\n\n<div class=\"ub-content-filter-panel\" style=\"\" data-selectedFilters=\"[[false,false,true,true],[true,false,false,false,true,false,false,false]]\" id=\"ub-content-filter-entry-block-\">\n\n<div style=\"height:10px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n<div class=\"wp-block-ub-content-toggle\" id=\"ub-content-toggle-f5c5a156-dbbf-4cbf-8521-7e15b9623474\" data-showonlyone=\"true\" data-mobilecollapse=\"false\" data-desktopcollapse=\"false\">\n<div class=\"wp-block-ub-content-toggle-accordion\" id=\"ub-content-toggle-panel-block-\">\n                <div class=\"wp-block-ub-content-toggle-accordion-title-wrap\"\" aria-controls=\"ub-content-toggle-panel-0-f5c5a156-dbbf-4cbf-8521-7e15b9623474\" tabindex=\"0\">\n                    <p class=\"wp-block-ub-content-toggle-accordion-title ub-content-toggle-title-f5c5a156-dbbf-4cbf-8521-7e15b9623474\"><strong>Is the Swiss Authorized Representative required to be on the device labeling?<\/strong><\/p><div class=\"wp-block-ub-content-toggle-accordion-toggle-wrap right\"><span class=\"wp-block-ub-content-toggle-accordion-state-indicator wp-block-ub-chevron-down\"><\/span>\n                    <\/div><\/div><div role=\"region\" aria-expanded=\"false\" class=\"wp-block-ub-content-toggle-accordion-content-wrap ub-hide\" id=\"ub-content-toggle-panel-0-f5c5a156-dbbf-4cbf-8521-7e15b9623474\">\n\n<p class=\"has-black-color has-text-color\">Yes, the Swiss Authorized Representative (CH-REP) is required to be on the device labeling.<\/p>\n\n\n\n<p class=\"has-black-color has-text-color\">More information about what must be included and where to place the CH-REP info can be found in our Knowledge Center: <strong><a href=\"https:\/\/casusconsulting.com\/in-country-representative-labeling-requirements\/\" data-type=\"URL\" data-id=\"https:\/\/casusconsulting.com\/in-country-representative-labeling-requirements\/\">L<\/a><a rel=\"noreferrer noopener\" href=\"https:\/\/casusconsulting.com\/in-country-representative-labeling-requirements\/\" data-type=\"URL\" data-id=\"https:\/\/casusconsulting.com\/in-country-representative-labeling-requirements\/\" target=\"_blank\">ABELING REQUIREMENTS FOR THE EU, UK AND SWITZERLAND IN-COUNTRY REPRESENTATIVE<\/a><\/strong><\/p>\n\n<\/div><\/div>\n<\/div>\n<\/div>\n\n<div class=\"ub-content-filter-panel\" style=\"\" data-selectedFilters=\"[[false,true,false,true],[true,false,false,false,true,false,false,false]]\" id=\"ub-content-filter-entry-block-\">\n\n<div style=\"height:10px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n<div class=\"wp-block-ub-content-toggle\" id=\"ub-content-toggle-7548c403-a0a8-4cde-b014-e808ce04b66a\" data-showonlyone=\"true\" data-mobilecollapse=\"false\" data-desktopcollapse=\"false\">\n<div class=\"wp-block-ub-content-toggle-accordion\" id=\"ub-content-toggle-panel-block-\">\n                <div class=\"wp-block-ub-content-toggle-accordion-title-wrap\"\" aria-controls=\"ub-content-toggle-panel-0-7548c403-a0a8-4cde-b014-e808ce04b66a\" tabindex=\"0\">\n                    <p class=\"wp-block-ub-content-toggle-accordion-title ub-content-toggle-title-7548c403-a0a8-4cde-b014-e808ce04b66a\"><strong>Is the UK Responsible Person (UKRP) required to be on the device labeling?<\/strong><\/p><div class=\"wp-block-ub-content-toggle-accordion-toggle-wrap right\"><span class=\"wp-block-ub-content-toggle-accordion-state-indicator wp-block-ub-chevron-down\"><\/span>\n                    <\/div><\/div><div role=\"region\" aria-expanded=\"false\" class=\"wp-block-ub-content-toggle-accordion-content-wrap ub-hide\" id=\"ub-content-toggle-panel-0-7548c403-a0a8-4cde-b014-e808ce04b66a\">\n\n<p class=\"has-black-color has-text-color\">It depends on if the manufacturer is leveraging UKCA Marking or EU CE Marking:<\/p>\n\n\n\n<ul class=\"has-black-color has-text-color\">\n<li><strong>Yes<\/strong>&nbsp;\u2013 If leveraging UKCA Marking<\/li>\n\n\n\n<li><strong>No<\/strong>&nbsp;\u2013 if leveraging EU CE Marking<\/li>\n<\/ul>\n\n\n\n<p class=\"has-black-color has-text-color\">More information about what must be included and where to place the UKRP info (if required) can be found in our Knowledge Center: <strong><a href=\"https:\/\/casusconsulting.com\/in-country-representative-labeling-requirements\/\" data-type=\"URL\" data-id=\"https:\/\/casusconsulting.com\/in-country-representative-labeling-requirements\/\">L<\/a><a rel=\"noreferrer noopener\" href=\"https:\/\/casusconsulting.com\/in-country-representative-labeling-requirements\/\" data-type=\"URL\" data-id=\"https:\/\/casusconsulting.com\/in-country-representative-labeling-requirements\/\" target=\"_blank\">ABELING REQUIREMENTS FOR THE EU, UK AND SWITZERLAND IN-COUNTRY REPRESENTATIVE<\/a><\/strong><\/p>\n\n<\/div><\/div>\n<\/div>\n<\/div>\n\n<div class=\"ub-content-filter-panel\" style=\"\" data-selectedFilters=\"[[true,true,true,true],[true,false,false,false,false,false,false,false]]\" id=\"ub-content-filter-entry-block-\">\n\n<div style=\"height:10px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n<div class=\"wp-block-ub-content-toggle\" id=\"ub-content-toggle-790fb47f-b2ef-4ff0-a6c1-e56f9860a962\" data-showonlyone=\"true\" data-mobilecollapse=\"false\" data-desktopcollapse=\"false\">\n<div class=\"wp-block-ub-content-toggle-accordion\" id=\"ub-content-toggle-panel-block-\">\n                <div class=\"wp-block-ub-content-toggle-accordion-title-wrap\"\" aria-controls=\"ub-content-toggle-panel-0-790fb47f-b2ef-4ff0-a6c1-e56f9860a962\" tabindex=\"0\">\n                    <p class=\"wp-block-ub-content-toggle-accordion-title ub-content-toggle-title-790fb47f-b2ef-4ff0-a6c1-e56f9860a962\"><strong>Is e-labeling allowed in the EU, UK and Switzerland?<\/strong><\/p><div class=\"wp-block-ub-content-toggle-accordion-toggle-wrap right\"><span class=\"wp-block-ub-content-toggle-accordion-state-indicator wp-block-ub-chevron-down\"><\/span>\n                    <\/div><\/div><div role=\"region\" aria-expanded=\"false\" class=\"wp-block-ub-content-toggle-accordion-content-wrap ub-hide\" id=\"ub-content-toggle-panel-0-790fb47f-b2ef-4ff0-a6c1-e56f9860a962\">\n\n<p class=\"has-black-color has-text-color\">E-labeling for medical devices and IVDs is allowable in certain cases in the EU, UK and Switzerland.&nbsp; The requirements are based on the application legislation and device type.&nbsp; The applicable regulations and guidances are linked at the bottom of this FAQ.<\/p>\n\n\n\n<p><strong>Medical Devices<\/strong><\/p>\n\n\n\n<p class=\"has-black-color has-text-color\">E-labeling is allowed for the following types of medical devices, if they are for professional use and use by other persons is not foreseeable:<\/p>\n\n\n\n<ul class=\"has-black-color has-text-color\">\n<li>Implantable and active implantable devices,<\/li>\n\n\n\n<li>Fixed installed medical devices and their accessories, and<\/li>\n\n\n\n<li>Medical devices and their accessories fitted with a built-in system visually displaying the instructions for use.   <\/li>\n<\/ul>\n\n\n\n<p class=\"has-black-color has-text-color\">For all three markets, e-labeling is also permitted for professional use software products.&nbsp; Further, under the updated e-labeling regulation related to the EU MDR, e-labeling is permitted for home-use software products.&nbsp; The UK and EU MDD\/IVDD\/IVDR regulations, do not explicitly allow e-labeling for home-use software products, but in certain cases this may be justified.&nbsp; Manufacturers can discuss further with their Notified Body (if applicable) or Competent Authority to confirm if it is allowable and should justify in their risk assessment that this will not impact the safe an effective use of the product with the end user.<\/p>\n\n\n\n<p class=\"has-black-color has-text-color\"><strong>IVDs<\/strong><\/p>\n\n\n\n<p class=\"has-black-color has-text-color\">E-labeling is allowed for professional-use IVDs that are not specifically intended for use at point of care.*<\/p>\n\n\n\n<p class=\"has-black-color has-text-color\"><strong>E-labeling Requirements<\/strong><\/p>\n\n\n\n<p class=\"has-black-color has-text-color\">Manufacturers should ensure they follow all the criteria outlined in the applicable regulation or guidance if choosing to offer e-labeling for their devices.&nbsp; This generally includes, but is not limited to:<\/p>\n\n\n\n<ul class=\"has-black-color has-text-color\">\n<li>Conducting a risk assessment that covers the criteria included in the applicable regulation\/guidance\n<ul>\n<li>Essentially, the assessment should demonstrate that the end-user has access to and knowledge of the technology being used to provide the e-IFU, sufficient back-up to provide the IFU if the technology fails, and that the user is able to receive the IFU in paper format, if needed\/requested.  <\/li>\n<\/ul>\n<\/li>\n\n\n\n<li>Ensuring the e-IFU meets all the local language requirements where the product is sold<\/li>\n\n\n\n<li>Developing a process where the user can request the paper IFU at no additional cost, within the time period established by the regulation or guidance\n<ul class=\"has-black-color has-text-color\">\n<li>For medical devices, this is noted as 7 days whereas for IVDs the regulation just states it must be provided in a timely manner.<\/li>\n<\/ul>\n<\/li>\n\n\n\n<li>Clearly indicating when the IFUs have been revised and the ability to inform the user if the revision was necessary for safety reasons<\/li>\n\n\n\n<li>Making the e-IFU accessible to users through a website that meets the criteria in the regulation or guidance<\/li>\n\n\n\n<li>In cases of medical devices with expiration dates, making the IFU available for the timeframes stipulated in the regulation or guidance:<ul><li>EU MDR: For non-implantable devices &#8211; 10 years after the last device has been placed on the market and at least two years after the expiry date of the last produced medical device.&nbsp; For implantable devices &#8211; 15 years after the last device has been placed on the market.<\/li><\/ul><ul><li>EU MDD\/UK MD: For non-implantable devices &#8211; at least two years after the expiry date of the last produced medical device.&nbsp; For implantable devices &#8211; 15 years after the last device has been placed on the market.<\/li><\/ul>\n<ul>\n<li>IVDs: The IVD guidance does not reference any specific timeline for keeping the IFU available for expired devices. However, the legislation imposes minimum document retention periods:<ul><li>IVDD \u2013 5 years after the last product has been manufactured<\/li><\/ul>\n<ul class=\"has-black-color has-text-color\">\n<li>IVDR \u2013 10 years after the last device has been placed onto the market<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n\n\n\n<p class=\"has-black-color has-text-color\">A full list of the criteria that must be met can be found in the regulation or guidance applicable to the market\/device (linked below).&nbsp;<\/p>\n\n\n\n<p class=\"has-black-color has-text-color\"><strong>Legislation and Guidances<\/strong><\/p>\n\n\n\n<ul class=\"has-black-color has-text-color\">\n<li><strong>Europe<\/strong><ul><li>MDD: <strong><a href=\"https:\/\/eur-lex.europa.eu\/LexUriServ\/LexUriServ.do?uri=OJ:L:2012:072:0028:0031:en:PDF\" target=\"_blank\" rel=\"noreferrer noopener\">COMMISSION REGULATION (EU) No 207\/2012<\/a><\/strong><\/li><\/ul><\/li>\n\n\n\n<li><ul><li>MDR: <strong><a href=\"https:\/\/eur-lex.europa.eu\/eli\/reg_impl\/2021\/2226\/oj\" target=\"_blank\" rel=\"noreferrer noopener\">COMMISSION IMPLEMENTING REGULATION (EU) 2021\/2226<\/a><\/strong><\/li><\/ul><\/li>\n\n\n\n<li><ul><li>IVDD: <strong><a href=\"https:\/\/ec.europa.eu\/docsroom\/documents\/10293\/attachments\/1\/translations\" target=\"_blank\" rel=\"noreferrer noopener\">MEDDEV 2.14\/3 rev.1<\/a><\/strong><\/li><\/ul>\n<ul>\n<li>IVDR: <strong><a href=\"https:\/\/eur-lex.europa.eu\/legal-content\/EN\/TXT\/?uri=CELEX%3A02017R0746-20230320\" target=\"_blank\" rel=\"noreferrer noopener\">REGULATION (EU) 2017\/746<\/a><\/strong>\u00a0 (Annex I, Chapter III, Section 20.1(f))\n<ul>\n<li>In absence of a Commission Implementing Regulation to the IVDR 2017\/746, manufacturers should consider the existing MEDDEV and MDR Commission Implementing Regulation for guidance.<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n\n\n\n<ul>\n<li><strong>United Kingdom<\/strong><ul><li>Medical Devices: <strong><a href=\"https:\/\/www.gov.uk\/government\/publications\/electronic-instructions-for-use-of-medical-devices-guidance-on-regulations\/guidance-on-the-regulations-for-electronic-instructions-for-use-of-medical-devices\" target=\"_blank\" rel=\"noreferrer noopener\">Guidance on the regulations for electronic instructions for use of medical devices<\/a><\/strong><\/li><\/ul>\n<ul class=\"has-black-color has-text-color\">\n<li>IVDs: <strong><a href=\"https:\/\/ec.europa.eu\/docsroom\/documents\/10293\/attachments\/1\/translations\" target=\"_blank\" rel=\"noreferrer noopener\">MEDDEV 2.14\/3 rev.1<\/a><\/strong><\/li>\n<\/ul>\n<\/li>\n<\/ul>\n\n\n\n<ul>\n<li><strong>Switzerland<\/strong>\n<ul class=\"has-black-color has-text-color\">\n<li>Swissmedic has not released any information related e-labeling requirements.&nbsp; However, as both the Swiss medical device (<strong><a href=\"https:\/\/www.fedlex.admin.ch\/eli\/cc\/2020\/552\/en\" target=\"_blank\" rel=\"noreferrer noopener\">MedDO<\/a><\/strong>) and IVD (<strong><a href=\"https:\/\/www.fedlex.admin.ch\/eli\/oc\/2022\/291\/de\" target=\"_blank\" rel=\"noreferrer noopener\">IvDO<\/a><\/strong>) regulations align with the EU MDR and IVDR respectively, and compliance with these regulations is currently required for commercializing devices in Switzerland, EU requirements for e-labeling can generally be followed in Switzerland as well.&nbsp; If there is a question if these requirements apply to a specific product, manufacturers should confirm with Swissmedic directly.<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n\n\n\n<p class=\"has-black-color has-text-color\"><em>*Point of Care Testing: Testing that is performed near or at the site of a patient with the result leading to a possible change in the care of a patient.<\/em><\/p>\n\n<\/div><\/div>\n<\/div>\n<\/div>\n\n<div class=\"ub-content-filter-panel\" style=\"\" data-selectedFilters=\"[[true,false,false,true],[false,false,false,false,false,true,false,false]]\" id=\"ub-content-filter-entry-block-\">\n\n<div style=\"height:10px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n<div class=\"wp-block-ub-content-toggle\" id=\"ub-content-toggle-363386a0-56d2-4c7b-a8b0-f3a52e378329\" data-showonlyone=\"true\" data-mobilecollapse=\"false\" data-desktopcollapse=\"false\">\n<div class=\"wp-block-ub-content-toggle-accordion\" id=\"ub-content-toggle-panel-block-\">\n                <div class=\"wp-block-ub-content-toggle-accordion-title-wrap\"\" aria-controls=\"ub-content-toggle-panel-0-363386a0-56d2-4c7b-a8b0-f3a52e378329\" tabindex=\"0\">\n                    <p class=\"wp-block-ub-content-toggle-accordion-title ub-content-toggle-title-363386a0-56d2-4c7b-a8b0-f3a52e378329\"><strong><strong><strong>What is the difference between a part, a component, and an accessory?<\/strong><\/strong><\/strong><\/p><div class=\"wp-block-ub-content-toggle-accordion-toggle-wrap right\"><span class=\"wp-block-ub-content-toggle-accordion-state-indicator wp-block-ub-chevron-down\"><\/span>\n                    <\/div><\/div><div role=\"region\" aria-expanded=\"false\" class=\"wp-block-ub-content-toggle-accordion-content-wrap ub-hide\" id=\"ub-content-toggle-panel-0-363386a0-56d2-4c7b-a8b0-f3a52e378329\">\n\n<p class=\"has-black-color has-text-color\">There are several factors that determine the difference between a part, a component, and an accessory. Questions the manufacturer may ask when determining if something is a spare\/replacement part, a component, or an accessory are:<\/p>\n\n\n\n<ul class=\"has-black-color has-text-color\">\n<li>Will the item be classified in its own right?<\/li>\n\n\n\n<li>Is the item a part of the finished device?<\/li>\n<\/ul>\n\n\n\n<p class=\"has-black-color has-text-color\">The MDR defines an accessory as an article that on its own is not a medical device; however, it is intended by the manufacturer to be used together with one or several specific medical devices to either:<\/p>\n\n\n\n<ul class=\"has-black-color has-text-color\">\n<li>enable the \u201cmain\u201d finished medical device to be used in accordance with its intended purpose, or<\/li>\n\n\n\n<li>assist the medical functionality of the \u201cmain\u201d finished medical device specifically and directly in terms of its intended purpose.<\/li>\n<\/ul>\n\n\n\n<p class=\"has-black-color has-text-color\">Accessories for medical devices are manufactured separately from the assembled and finished device it supports, bear CE Marking, and are individually classified (separate from the \u201cmain\u201d device) \u2013 except for accessories for active implantable devices, which are Class III.<\/p>\n\n\n\n<p class=\"has-black-color has-text-color\">Parts and components are terms generally used synonymously. The MDR does not define a component or a part, but they are generally an integral part of the assembled and finished medical device, and without which the finished device would not be able to function to its intended purpose. Components\/parts do not bear individual CE Marking and are instead part of the finished device\u2019s CE Marking.<\/p>\n\n\n\n<p class=\"has-black-color has-text-color\">A device\u2019s parts\/components may become worn or defective and need to be replaced. Replacements may be made as long as it does not adversely affect, or significantly change, the safety and performance of the device. In this case, the replacement part\/component being shipped would not bear individual CE Marking.&nbsp;<\/p>\n\n<\/div><\/div>\n<\/div>\n<\/div>\n\n<div class=\"ub-content-filter-panel\" style=\"\" data-selectedFilters=\"[[true,false,false,true],[false,false,true,false,false,false,false,false]]\" id=\"ub-content-filter-entry-block-\">\n\n<div style=\"height:10px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n<div class=\"wp-block-ub-content-toggle\" id=\"ub-content-toggle-72ec9fb3-a65b-4b03-826e-752c675e3b39\" data-showonlyone=\"true\" data-mobilecollapse=\"false\" data-desktopcollapse=\"false\">\n<div class=\"wp-block-ub-content-toggle-accordion\" id=\"ub-content-toggle-panel-block-\">\n                <div class=\"wp-block-ub-content-toggle-accordion-title-wrap\"\" aria-controls=\"ub-content-toggle-panel-0-72ec9fb3-a65b-4b03-826e-752c675e3b39\" tabindex=\"0\">\n                    <p class=\"wp-block-ub-content-toggle-accordion-title ub-content-toggle-title-72ec9fb3-a65b-4b03-826e-752c675e3b39\"><strong><strong>Can I ship non-CE Marked medical devices to the European Union for demo\/tradeshow purposes?<\/strong><\/strong><\/p><div class=\"wp-block-ub-content-toggle-accordion-toggle-wrap right\"><span class=\"wp-block-ub-content-toggle-accordion-state-indicator wp-block-ub-chevron-down\"><\/span>\n                    <\/div><\/div><div role=\"region\" aria-expanded=\"false\" class=\"wp-block-ub-content-toggle-accordion-content-wrap ub-hide\" id=\"ub-content-toggle-panel-0-72ec9fb3-a65b-4b03-826e-752c675e3b39\">\n\n<p class=\"has-black-color has-text-color\">Yes, it is possible to send non-CE-marked medical devices to Europe for exhibition and demonstration purposes.<\/p>\n\n\n\n<p class=\"has-black-color has-text-color\">The requirements are to ensure that the device clearly indicates that it is:<\/p>\n\n\n\n<ul class=\"has-black-color has-text-color\">\n<li>Intended for presentation or demonstration purposes only, and<\/li>\n\n\n\n<li>May not be made available until it is in compliance with the MDR or IVDR, as applicable.<\/li>\n<\/ul>\n\n\n\n<p class=\"has-black-color has-text-color\">This is allowed per MDR Article 21 and IVDR Article 19:<\/p>\n\n\n\n<p class=\"has-black-color has-text-color\">\u201c<em>At trade fairs, exhibitions, demonstrations or similar events, Member States shall not create obstacles to the showing of devices which do not comply with this Regulation, provided that a visible sign clearly indicates that such devices are intended for presentation or demonstration purposes only and cannot be made available until they have been brought into compliance with this Regulation.<\/em>\u201d<\/p>\n\n<\/div><\/div>\n<\/div>\n<\/div>\n\n<div class=\"ub-content-filter-panel\" style=\"\" data-selectedFilters=\"[[false,true,false,true],[false,false,true,false,false,false,false,false]]\" id=\"ub-content-filter-entry-block-\">\n\n<div style=\"height:10px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n<div class=\"wp-block-ub-content-toggle\" id=\"ub-content-toggle-e21eec35-6448-4f45-ba75-9f90680732e4\" data-showonlyone=\"true\" data-mobilecollapse=\"false\" data-desktopcollapse=\"false\">\n<div class=\"wp-block-ub-content-toggle-accordion\" id=\"ub-content-toggle-panel-block-\">\n                <div class=\"wp-block-ub-content-toggle-accordion-title-wrap\"\" aria-controls=\"ub-content-toggle-panel-0-e21eec35-6448-4f45-ba75-9f90680732e4\" tabindex=\"0\">\n                    <p class=\"wp-block-ub-content-toggle-accordion-title ub-content-toggle-title-e21eec35-6448-4f45-ba75-9f90680732e4\"><strong><strong>Can I ship non-CE\/UKCA Marked medical devices to the UK for demo\/tradeshow purposes?<\/strong><\/strong><\/p><div class=\"wp-block-ub-content-toggle-accordion-toggle-wrap right\"><span class=\"wp-block-ub-content-toggle-accordion-state-indicator wp-block-ub-chevron-down\"><\/span>\n                    <\/div><\/div><div role=\"region\" aria-expanded=\"false\" class=\"wp-block-ub-content-toggle-accordion-content-wrap ub-hide\" id=\"ub-content-toggle-panel-0-e21eec35-6448-4f45-ba75-9f90680732e4\">\n\n<p class=\"has-black-color has-text-color\">Yes, it is possible to send non-UKCA or non-CE Marked medical devices to the UK for exhibition and demonstration purposes.<\/p>\n\n\n\n<p class=\"has-black-color has-text-color\">The requirements are to ensure that there is a visible sign clearly indicating that the device cannot be marketed or put into service until it complies with the regulation. For IVD devices there is an additional requirement that \u201c<em>the device is not used on any specimen taken from the participants<\/em>\u201d.<\/p>\n\n\n\n<p class=\"has-black-color has-text-color\">This is allowed per UK MDR 2002, Part II, Section 12:<\/p>\n\n\n\n<p class=\"has-black-color has-text-color\"><em>\u201cA relevant device or a single-use combination product being shown at a trade fair, exhibition, demonstration or similar gathering is not being placed on the market or put into service if a visible sign clearly indicates that the device or product cannot be marketed or put into service until it complies with the requirements of Directive 93\/42 or these Regulations.\u201d<\/em><\/p>\n\n\n\n<p class=\"has-black-color has-text-color\">The citation for Active Implantable Devices is UK MDR 2002, Part III, Section 26, and for IVDs it is UK MDR 2002, Part IV, Section 39.<\/p>\n\n<\/div><\/div>\n<\/div>\n<\/div>\n\n<div class=\"ub-content-filter-panel\" style=\"\" data-selectedFilters=\"[[false,false,true,true],[false,false,true,false,false,false,false,false]]\" id=\"ub-content-filter-entry-block-\">\n\n<div style=\"height:10px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n<div class=\"wp-block-ub-content-toggle\" id=\"ub-content-toggle-5a704dae-09ba-4d50-a2b4-aee2979aa07f\" data-showonlyone=\"true\" data-mobilecollapse=\"false\" data-desktopcollapse=\"false\">\n<div class=\"wp-block-ub-content-toggle-accordion\" id=\"ub-content-toggle-panel-block-\">\n                <div class=\"wp-block-ub-content-toggle-accordion-title-wrap\"\" aria-controls=\"ub-content-toggle-panel-0-5a704dae-09ba-4d50-a2b4-aee2979aa07f\" tabindex=\"0\">\n                    <p class=\"wp-block-ub-content-toggle-accordion-title ub-content-toggle-title-5a704dae-09ba-4d50-a2b4-aee2979aa07f\"><strong><strong>Can I ship non-CE Marked medical devices to Switzerland for demo\/tradeshow purposes?<\/strong><\/strong><\/p><div class=\"wp-block-ub-content-toggle-accordion-toggle-wrap right\"><span class=\"wp-block-ub-content-toggle-accordion-state-indicator wp-block-ub-chevron-down\"><\/span>\n                    <\/div><\/div><div role=\"region\" aria-expanded=\"false\" class=\"wp-block-ub-content-toggle-accordion-content-wrap ub-hide\" id=\"ub-content-toggle-panel-0-5a704dae-09ba-4d50-a2b4-aee2979aa07f\">\n\n<p class=\"has-black-color has-text-color\">Yes, it is possible to send non-CE-marked medical devices to Switzerland for exhibition and demonstration purposes.<\/p>\n\n\n\n<p class=\"has-black-color has-text-color\">The requirements are to ensure that the device clearly indicates that it is intended solely for demonstration and presentation purposes.<\/p>\n\n\n\n<p class=\"has-black-color has-text-color\">This is allowed per MedDO Article 16 and IvDO Article 15:<\/p>\n\n\n\n<p class=\"has-black-color has-text-color\"><em>\u201cProducts that are used exclusively for demonstration and exhibition purposes must be expressly designated as such.&nbsp;This notice must be clearly visible and understandable.\u201d<\/em><\/p>\n\n<\/div><\/div>\n<\/div>\n<\/div>\n\n<div class=\"ub-content-filter-panel\" style=\"\" data-selectedFilters=\"[[true,false,false,true],[false,false,false,true,false,false,false,false]]\" id=\"ub-content-filter-entry-block-\">\n\n<div style=\"height:10px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n<div class=\"wp-block-ub-content-toggle\" id=\"ub-content-toggle-fb10c97f-3fe1-4f9b-b0df-67ba0e7de5d4\" data-showonlyone=\"true\" data-mobilecollapse=\"false\" data-desktopcollapse=\"false\">\n<div class=\"wp-block-ub-content-toggle-accordion\" id=\"ub-content-toggle-panel-block-\">\n                <div class=\"wp-block-ub-content-toggle-accordion-title-wrap\"\" aria-controls=\"ub-content-toggle-panel-0-fb10c97f-3fe1-4f9b-b0df-67ba0e7de5d4\" tabindex=\"0\">\n                    <p class=\"wp-block-ub-content-toggle-accordion-title ub-content-toggle-title-fb10c97f-3fe1-4f9b-b0df-67ba0e7de5d4\"><strong><strong>Is a Person Responsible for Regulatory Compliance (PRRC) required in the EU?<\/strong><\/strong><\/p><div class=\"wp-block-ub-content-toggle-accordion-toggle-wrap right\"><span class=\"wp-block-ub-content-toggle-accordion-state-indicator wp-block-ub-chevron-down\"><\/span>\n                    <\/div><\/div><div role=\"region\" aria-expanded=\"false\" class=\"wp-block-ub-content-toggle-accordion-content-wrap ub-hide\" id=\"ub-content-toggle-panel-0-fb10c97f-3fe1-4f9b-b0df-67ba0e7de5d4\">\n\n<p class=\"has-black-color has-text-color\">A Person Responsible for Regulatory Compliance (PRRC) may be required for the EU, depending on the legislation being applied (new regulations or old directives) to the device being placed on the market.&nbsp; Where required, the role is applicable to both manufacturers commercializing in the EU and EU Authorized Representatives (EU ARs).&nbsp;<\/p>\n\n\n\n<p class=\"has-black-color has-text-color\">A PRRC is required for the manufacturer and EU AR when a device complies with the EU MDR or IVDR.&nbsp; This requirement is included in Articles 15 of each regulation.<\/p>\n\n\n\n<p class=\"has-black-color has-text-color\">A PRRC is not required for devices conforming with the MDD, IVDD, or AIMDD, i.e., it is not required for legacy devices.&nbsp; This is stated in the MDCG\u2019s guidance documents detailing with which elements of the regulations legacy devices need to comply (medical devices: <a rel=\"noreferrer noopener\" href=\"https:\/\/health.ec.europa.eu\/document\/download\/cbb11a6e-f0f3-4e30-af5e-990f9ef68bc1_en?filename=md_mdcg_2021_25_en.pdf\" target=\"_blank\"><strong>MDCG 2021-25<\/strong><\/a>, IVDs:<strong> <a rel=\"noreferrer noopener\" href=\"https:\/\/health.ec.europa.eu\/document\/download\/76f9983e-164c-45f1-b2b9-c9e5050cefe9_en?filename=mdcg_2022-8_en.pdf\" target=\"_blank\">MDCG 2022-8<\/a><\/strong>). The guidances state that Article 15 (PRRC requirements) is not applicable for MDD\/IVDD\/AIMDD devices.<\/p>\n\n<\/div><\/div>\n<\/div>\n<\/div>\n\n<div class=\"ub-content-filter-panel\" style=\"\" data-selectedFilters=\"[[false,true,false,true],[false,false,false,true,false,false,false,false]]\" id=\"ub-content-filter-entry-block-\">\n\n<div style=\"height:10px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n<div class=\"wp-block-ub-content-toggle\" id=\"ub-content-toggle-6df006b5-7be8-4db7-9799-27b696bb22bf\" data-showonlyone=\"true\" data-mobilecollapse=\"false\" data-desktopcollapse=\"false\">\n<div class=\"wp-block-ub-content-toggle-accordion\" id=\"ub-content-toggle-panel-block-\">\n                <div class=\"wp-block-ub-content-toggle-accordion-title-wrap\"\" aria-controls=\"ub-content-toggle-panel-0-6df006b5-7be8-4db7-9799-27b696bb22bf\" tabindex=\"0\">\n                    <p class=\"wp-block-ub-content-toggle-accordion-title ub-content-toggle-title-6df006b5-7be8-4db7-9799-27b696bb22bf\"><strong><strong>Is a Person Responsible for Regulatory Compliance (PRRC) in the UK?<\/strong><\/strong><\/p><div class=\"wp-block-ub-content-toggle-accordion-toggle-wrap right\"><span class=\"wp-block-ub-content-toggle-accordion-state-indicator wp-block-ub-chevron-down\"><\/span>\n                    <\/div><\/div><div role=\"region\" aria-expanded=\"false\" class=\"wp-block-ub-content-toggle-accordion-content-wrap ub-hide\" id=\"ub-content-toggle-panel-0-6df006b5-7be8-4db7-9799-27b696bb22bf\">\n\n<p class=\"has-black-color has-text-color\">No, a PRRC is not currently required for manufacturers commercializing in the UK nor for UK Responsible Persons (UKRPs).&nbsp;<\/p>\n\n\n\n<p class=\"has-black-color has-text-color\">The current UK regulations (UK Medical Device Regulation 2002) are based on the old EU directives, which had not yet established the PRRC role.&nbsp;However, the new UK regulation is expected to introduce a role similar to the EU PRRC. The draft regulation refers to this role as a \u2018Qualified Person\u2019. A Qualified Person will be required for both the manufacturer and the UKRP.<\/p>\n\n<\/div><\/div>\n<\/div>\n<\/div>\n\n<div class=\"ub-content-filter-panel\" style=\"\" data-selectedFilters=\"[[false,false,true,true],[false,false,false,true,false,false,false,false]]\" id=\"ub-content-filter-entry-block-\">\n\n<div style=\"height:10px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n<div class=\"wp-block-ub-content-toggle\" id=\"ub-content-toggle-28bc311f-6f46-43f4-9226-da3999b95bfc\" data-showonlyone=\"true\" data-mobilecollapse=\"false\" data-desktopcollapse=\"false\">\n<div class=\"wp-block-ub-content-toggle-accordion\" id=\"ub-content-toggle-panel-block-\">\n                <div class=\"wp-block-ub-content-toggle-accordion-title-wrap\"\" aria-controls=\"ub-content-toggle-panel-0-28bc311f-6f46-43f4-9226-da3999b95bfc\" tabindex=\"0\">\n                    <p class=\"wp-block-ub-content-toggle-accordion-title ub-content-toggle-title-28bc311f-6f46-43f4-9226-da3999b95bfc\"><strong><strong>Is a Person Responsible for Regulatory Compliance (PRRC) in Switzerland?<\/strong><\/strong><\/p><div class=\"wp-block-ub-content-toggle-accordion-toggle-wrap right\"><span class=\"wp-block-ub-content-toggle-accordion-state-indicator wp-block-ub-chevron-down\"><\/span>\n                    <\/div><\/div><div role=\"region\" aria-expanded=\"false\" class=\"wp-block-ub-content-toggle-accordion-content-wrap ub-hide\" id=\"ub-content-toggle-panel-0-28bc311f-6f46-43f4-9226-da3999b95bfc\">\n\n<p class=\"has-black-color has-text-color\">A Person Responsible for Regulatory Compliance (PRRC) may be required for Switzerland, depending on the EU legislation being applied (new regulations or old directives) to the device being placed on the market.&nbsp; Where required, the role is applicable to both manufacturers commercializing in Switzerland and Swiss Authorized Representatives (CH-REP).<br><br>A PRRC is required for the manufacturer and CH-REP when a device complies with the EU MDR or IVDR. A PRRC is not required for devices conforming with the MDD, IVDD, or AIMDD, i.e., it is not required for legacy devices.<br><br>The Swiss MedDO and IvDO establish requirements this role. For medical devices, the PRRC requirements for the manufacturer are included in&nbsp;<a rel=\"noreferrer noopener\" href=\"https:\/\/www.fedlex.admin.ch\/eli\/cc\/2020\/552\/en#art_49\" target=\"_blank\"><strong>MedDO Art. 49<\/strong><\/a>&nbsp;and for CH-REP the requirements are in included in&nbsp;<a rel=\"noreferrer noopener\" href=\"https:\/\/www.fedlex.admin.ch\/eli\/cc\/2020\/552\/en#art_52\" target=\"_blank\"><strong>MedDO Art. 52<\/strong>.<\/a>&nbsp; For IVDs, the PRRC requirements for the manufacturer are included in&nbsp;<a rel=\"noreferrer noopener\" href=\"https:\/\/www.fedlex.admin.ch\/eli\/oc\/2022\/291\/en\" target=\"_blank\"><strong>IvDO Art. 42<\/strong><\/a>&nbsp;and for CH-REP the requirements are in included in&nbsp;<a rel=\"noreferrer noopener\" href=\"https:\/\/www.fedlex.admin.ch\/eli\/oc\/2022\/291\/en\" target=\"_blank\"><strong>IvDO Art. 45<\/strong><\/a>.&nbsp;<br><br>Both the Ordinances also reference the PRRC requirements in the MDR and IVDR (Article 15) as obligations that the PRRC must meet.&nbsp; So, PRRCs complying with Swiss requires should also review and comply with the requirements for the EU regulations, in addition to what is included in the Swiss Ordinances. For example, the Swiss Ordinances also specify that both a PRRC and a deputy PRRC must be appointed.<br><br>Swissmedic specifies some additional differences between the Swiss and EU PRRC requirements in <a rel=\"noreferrer noopener\" href=\"https:\/\/www.swissmedic.ch\/swissmedic\/en\/home\/medical-devices\/regulation-of-medical-devices\/faq.html\" target=\"_blank\"><strong>the FAQ section<\/strong><\/a> on their website:<\/p>\n\n\n\n<p><strong><em>Must the PRRC of a Swiss authorised representative or Swiss manufacturer be domiciled in Switzerland?<\/em><\/strong><em><\/em><\/p>\n\n\n\n<p class=\"has-black-color has-text-color\"><em>MedDO and&nbsp;IvDO&nbsp;do&nbsp;<strong>not<\/strong>&nbsp;define a requirement for the PRRC to be domiciled in the same jurisdiction in which the authorised representative or manufacturer is domiciled. What is relevant is that the PRRC is organisationally and professionally integrated over the long term and performs its tasks.<\/em><\/p>\n\n\n\n<p class=\"has-black-color has-text-color\"><strong><em>Can the manufacturer&#8217;s PRRC also act for the authorised representative?<\/em><\/strong><\/p>\n\n\n\n<p class=\"has-black-color has-text-color\"><em>MedDO and IvDO do not specify any corresponding requirements, i.e. the possibility that the PRRC of the swiss authorised representative may also be the PRRC of an EC-REP or manufacturer is not ruled out.<\/em><\/p>\n\n<\/div><\/div>\n<\/div>\n<\/div>\n\n<div class=\"ub-content-filter-panel\" style=\"\" data-selectedFilters=\"[[true,false,true,true],[false,false,false,true,false,false,false,false]]\" id=\"ub-content-filter-entry-block-\">\n\n<div style=\"height:10px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n<div class=\"wp-block-ub-content-toggle\" id=\"ub-content-toggle-6b8c1a96-f07f-4be6-b0d5-f1f1a12c8058\" data-showonlyone=\"true\" data-mobilecollapse=\"false\" data-desktopcollapse=\"false\">\n<div class=\"wp-block-ub-content-toggle-accordion\" id=\"ub-content-toggle-panel-block-\">\n                <div class=\"wp-block-ub-content-toggle-accordion-title-wrap\"\" aria-controls=\"ub-content-toggle-panel-0-6b8c1a96-f07f-4be6-b0d5-f1f1a12c8058\" tabindex=\"0\">\n                    <p class=\"wp-block-ub-content-toggle-accordion-title ub-content-toggle-title-6b8c1a96-f07f-4be6-b0d5-f1f1a12c8058\"><strong>What qualifications are required for a Person Responsible for Regulatory Compliance (PRRC)?<\/strong><\/p><div class=\"wp-block-ub-content-toggle-accordion-toggle-wrap right\"><span class=\"wp-block-ub-content-toggle-accordion-state-indicator wp-block-ub-chevron-down\"><\/span>\n                    <\/div><\/div><div role=\"region\" aria-expanded=\"false\" class=\"wp-block-ub-content-toggle-accordion-content-wrap ub-hide\" id=\"ub-content-toggle-panel-0-6b8c1a96-f07f-4be6-b0d5-f1f1a12c8058\">\n\n<p class=\"has-black-color has-text-color\">For both manufacturers and Authorized Representatives, the PRRC must meet one of the qualifications established in Articles 15 of the MDR\/IVDR.&nbsp; This applies to PRRCs in the EU and Switzerland, as the Swiss MedDO and IvDO also reference Article 15 of the MDR\/IVDR when stipulating the PRRC requirements to meet.<\/p>\n\n\n\n<p class=\"has-black-color has-text-color\">The qualifications are:<\/p>\n\n\n\n<ul class=\"has-black-color has-text-color\">\n<li>A diploma, certificate or other evidence of formal qualification, awarded on completion of a university degree or of a course of study recognized as equivalent by the Member State concerned, in law, medicine, pharmacy, engineering or another relevant scientific discipline, and at least one year of professional experience in regulatory affairs or in quality management systems relating to medical devices and\/or&nbsp;<em>in vitro<\/em>&nbsp;diagnostic medical devices;<\/li>\n\n\n\n<li>four years of professional experience in regulatory affairs or in quality management systems relating to&nbsp;medical devices and\/or <em>in vitro<\/em>&nbsp;diagnostic medical devices.<\/li>\n<\/ul>\n\n\n\n<p class=\"has-black-color has-text-color\">The MDCG guidance document on the PRRC role (<a rel=\"noreferrer noopener\" href=\"https:\/\/health.ec.europa.eu\/document\/download\/463b4f08-44a2-4018-9957-488bf386fc3a_en?filename=md_mdcg_2019_7_guidance_art15_mdr_ivdr_en.pdf\" target=\"_blank\"><strong>MDCG 2019-7<\/strong><\/a>) further clarifies the following two points related to the PRRC qualification requirements:<\/p>\n\n\n\n<ul class=\"has-black-color has-text-color\">\n<li>Any qualification acquired outside the EU, including any university diplomas or certificates, should have been recognized by an EU Member State as equivalent to the EU corresponding qualification.<\/li>\n\n\n\n<li>Professional experience in regulatory affairs or in quality management systems relating to medical devices should be related to the EU requirements in the field.<\/li>\n<\/ul>\n\n<\/div><\/div>\n<\/div>\n<\/div>\n\n<div class=\"ub-content-filter-panel\" style=\"\" data-selectedFilters=\"[[true,false,true,true],[false,false,false,true,false,false,false,false]]\" id=\"ub-content-filter-entry-block-\">\n\n<div style=\"height:10px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n<div class=\"wp-block-ub-content-toggle\" id=\"ub-content-toggle-60eca0d9-b202-43b6-b602-d199349336f5\" data-showonlyone=\"true\" data-mobilecollapse=\"false\" data-desktopcollapse=\"false\">\n<div class=\"wp-block-ub-content-toggle-accordion\" id=\"ub-content-toggle-panel-block-\">\n                <div class=\"wp-block-ub-content-toggle-accordion-title-wrap\"\" aria-controls=\"ub-content-toggle-panel-0-60eca0d9-b202-43b6-b602-d199349336f5\" tabindex=\"0\">\n                    <p class=\"wp-block-ub-content-toggle-accordion-title ub-content-toggle-title-60eca0d9-b202-43b6-b602-d199349336f5\"><strong>Can manufacturers outsource the PRRC role?<\/strong><\/p><div class=\"wp-block-ub-content-toggle-accordion-toggle-wrap right\"><span class=\"wp-block-ub-content-toggle-accordion-state-indicator wp-block-ub-chevron-down\"><\/span>\n                    <\/div><\/div><div role=\"region\" aria-expanded=\"false\" class=\"wp-block-ub-content-toggle-accordion-content-wrap ub-hide\" id=\"ub-content-toggle-panel-0-60eca0d9-b202-43b6-b602-d199349336f5\">\n\n<p class=\"has-black-color has-text-color\">Manufacturers may be able to outsource the PRRC role depending on the size and revenue of the company.<\/p>\n\n\n\n<p class=\"has-black-color has-text-color\">Per MDR and IVDR article 15(2), micro and small manufacturers \u201cshall not be required to have the person responsible for regulatory compliance within their organisation but shall have such person permanently and continuously at their disposal.\u201d<\/p>\n\n\n\n<p class=\"has-black-color has-text-color\">Footnote 3 of the MDCG PRRC guidance (<a rel=\"noreferrer noopener\" href=\"https:\/\/health.ec.europa.eu\/document\/download\/463b4f08-44a2-4018-9957-488bf386fc3a_en?filename=md_mdcg_2019_7_guidance_art15_mdr_ivdr_en.pdf\" target=\"_blank\"><strong>MDCG 2019-7<\/strong><\/a>) further clarifies that \u2018micro and small manufacturers\u2019 means entities with fewer than 50 employees and\/or where the annual revenue does not exceed \u20ac10 million.&nbsp; In these cases, the PRRC role can be outsourced.<\/p>\n\n\n\n<p class=\"has-black-color has-text-color\">If the PRRC role is outsourced, the manufacturer must demonstrate how the PRRC is permanently and continuously at the disposal of the company.&nbsp; Further, the PRRC\u2019s qualifications must be documented. Generally, this is done with a contract.<\/p>\n\n<\/div><\/div>\n<\/div>\n<\/div>\n\n<div class=\"ub-content-filter-panel\" style=\"\" data-selectedFilters=\"[[true,true,true,true],[false,false,true,false,false,false,false,false]]\" id=\"ub-content-filter-entry-block-\">\n\n<div style=\"height:10px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n<div class=\"wp-block-ub-content-toggle\" id=\"ub-content-toggle-c89a653b-fa55-453b-b87d-aa4a88e127fd\" data-showonlyone=\"true\" data-mobilecollapse=\"false\" data-desktopcollapse=\"false\">\n<div class=\"wp-block-ub-content-toggle-accordion\" id=\"ub-content-toggle-panel-block-\">\n                <div class=\"wp-block-ub-content-toggle-accordion-title-wrap\"\" aria-controls=\"ub-content-toggle-panel-0-c89a653b-fa55-453b-b87d-aa4a88e127fd\" tabindex=\"0\">\n                    <p class=\"wp-block-ub-content-toggle-accordion-title ub-content-toggle-title-c89a653b-fa55-453b-b87d-aa4a88e127fd\"><strong>What is the definition of &#8216;placing on the market&#8217; in the EU, UK and Switzerland?<\/strong><\/p><div class=\"wp-block-ub-content-toggle-accordion-toggle-wrap right\"><span class=\"wp-block-ub-content-toggle-accordion-state-indicator wp-block-ub-chevron-down\"><\/span>\n                    <\/div><\/div><div role=\"region\" aria-expanded=\"false\" class=\"wp-block-ub-content-toggle-accordion-content-wrap ub-hide\" id=\"ub-content-toggle-panel-0-c89a653b-fa55-453b-b87d-aa4a88e127fd\">\n\n<p class=\"has-black-color has-text-color\">The definition of &#8216;placing on the market&#8217; in the EU, UK and Switzerland can be found in our Knowledge Center: <a rel=\"noreferrer noopener\" href=\"https:\/\/casusconsulting.com\/placing-on-market-eu-uk-switzerland\/\" target=\"_blank\"><strong>&#8216;PLACING ON THE MARKET\u2019 &#8211; DEFINITION AND CUTOFF FOR EU, UK &amp; SWITZERLAND<\/strong><\/a><\/p>\n\n<\/div><\/div>\n<\/div>\n<\/div>\n\n<div class=\"ub-content-filter-panel\" style=\"\" data-selectedFilters=\"[[true,true,false,true],[false,false,false,false,false,false,false,false]]\" id=\"ub-content-filter-entry-block-\">\n\n<div style=\"height:10px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n<div class=\"wp-block-ub-content-toggle\" id=\"ub-content-toggle-177c801d-441e-4bf6-b75d-ace3354ec1b1\" data-showonlyone=\"true\" data-mobilecollapse=\"false\" data-desktopcollapse=\"false\">\n<div class=\"wp-block-ub-content-toggle-accordion\" id=\"ub-content-toggle-panel-block-\">\n                <div class=\"wp-block-ub-content-toggle-accordion-title-wrap\"\" aria-controls=\"ub-content-toggle-panel-0-177c801d-441e-4bf6-b75d-ace3354ec1b1\" tabindex=\"0\">\n                    <p class=\"wp-block-ub-content-toggle-accordion-title ub-content-toggle-title-177c801d-441e-4bf6-b75d-ace3354ec1b1\"><strong>What is the difference between GMDN, EMDN and CND Codes?<\/strong><\/p><div class=\"wp-block-ub-content-toggle-accordion-toggle-wrap right\"><span class=\"wp-block-ub-content-toggle-accordion-state-indicator wp-block-ub-chevron-down\"><\/span>\n                    <\/div><\/div><div role=\"region\" aria-expanded=\"false\" class=\"wp-block-ub-content-toggle-accordion-content-wrap ub-hide\" id=\"ub-content-toggle-panel-0-177c801d-441e-4bf6-b75d-ace3354ec1b1\">\n\n<p class=\"has-black-color has-text-color\">An overview of the differences between GMDN, EMDN and CND codes can be found in our Knowledge Center: <a href=\"https:\/\/casusconsulting.com\/gmdn-emdn-and-cnd\/\" data-type=\"URL\" data-id=\"https:\/\/casusconsulting.com\/gmdn-emdn-and-cnd\/\" target=\"_blank\" rel=\"noreferrer noopener\"><strong>GMDN, EMDN AND CND: WHAT IS THE DIFFERENCE?<\/strong><\/a><\/p>\n\n<\/div><\/div>\n<\/div>\n<\/div>\n\n<div class=\"ub-content-filter-panel\" style=\"\" data-selectedFilters=\"[[true,true,false,true],[false,false,true,false,false,false,false,false]]\" id=\"ub-content-filter-entry-block-\">\n\n<div style=\"height:10px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n<div class=\"wp-block-ub-content-toggle\" id=\"ub-content-toggle-095e62cb-ac5c-4202-8823-baf0735b4511\" data-showonlyone=\"true\" data-mobilecollapse=\"false\" data-desktopcollapse=\"false\">\n<div class=\"wp-block-ub-content-toggle-accordion\" id=\"ub-content-toggle-panel-block-\">\n                <div class=\"wp-block-ub-content-toggle-accordion-title-wrap\"\" aria-controls=\"ub-content-toggle-panel-0-095e62cb-ac5c-4202-8823-baf0735b4511\" tabindex=\"0\">\n                    <p class=\"wp-block-ub-content-toggle-accordion-title ub-content-toggle-title-095e62cb-ac5c-4202-8823-baf0735b4511\"><strong><strong>What are the requirements to sell medical devices and IVDs in Northern Ireland?<\/strong><\/strong><\/p><div class=\"wp-block-ub-content-toggle-accordion-toggle-wrap right\"><span class=\"wp-block-ub-content-toggle-accordion-state-indicator wp-block-ub-chevron-down\"><\/span>\n                    <\/div><\/div><div role=\"region\" aria-expanded=\"false\" class=\"wp-block-ub-content-toggle-accordion-content-wrap ub-hide\" id=\"ub-content-toggle-panel-0-095e62cb-ac5c-4202-8823-baf0735b4511\">\n\n<p class=\"has-black-color has-text-color\">The requirements to sell medical devices and IVDs in Northern Ireland can be found in our Knowledge Center: <a rel=\"noreferrer noopener\" href=\"https:\/\/casusconsulting.com\/northern-ireland-medical-device-requirements\/\" target=\"_blank\"><strong>NORTHERN IRELAND MEDICAL DEVICE REQUIREMENTS<\/strong><\/a><\/p>\n\n<\/div><\/div>\n<\/div>\n<\/div>\n<\/div>","protected":false},"excerpt":{"rendered":"<p>Frequently Asked Questions<\/p>\n","protected":false},"author":1,"featured_media":6760,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"ub_ctt_via":"","footnotes":""},"categories":[1],"tags":[],"cp_meta_data":{"_edit_lock":["1711650186:4"],"_tve_js_modules_gutenberg":["a:1:{i:0;s:9:\"gutenberg\";}"],"_edit_last":["4"],"hefo_before":["0"],"hefo_after":["0"],"cmplz_hide_cookiebanner":[""],"mfn-post-hide-content":["0"],"mfn-post-layout":["no-sidebar"],"mfn-post-sidebar":["0"],"mfn-post-sidebar2":["0"],"mfn-post-slider":["0"],"mfn-post-slider-layer":["0"],"mfn-post-full-width":["0"],"mfn-post-hide-title":["0"],"mfn-post-remove-padding":["0"],"mfn-post-intro":["a:1:{s:9:\"post-meta\";s:1:\"1\";}"],"mfn-post-hide-image":["0"],"jbp-single-post":["a:3:{s:8:\"override\";s:1:\"0\";s:22:\"single_template_custom\";s:1:\"0\";s:5:\"nonce\";s:10:\"8af2961376\";}"],"_wpb_vc_js_status":["false"],"mfn-post-template":["builder"],"tve_landing_page":[""],"tve_disable_theme_dependency":[""],"tve_content_before_more":[""],"tve_content_more_found":[""],"tve_save_post":[""],"tve_custom_css":[""],"tve_user_custom_css":[""],"tve_page_events":[""],"tve_globals":[""],"tve_global_scripts":[""],"thrive_icon_pack":[""],"thrive_tcb_post_fonts":[""],"tve_has_masonry":[""],"tve_has_typefocus":[""],"tve_updated_post":[""],"tve_has_wistia_popover":[""],"_thumbnail_id":["6760"],"footnotes":[""],"_cmplz_scanned_post":["1"]},"featured_image_src":"https:\/\/casusconsulting.com\/wp-content\/uploads\/2022\/03\/shutterstock_420798184-scaled.jpg","author_info":{"display_name":"Sydney","author_link":"https:\/\/casusconsulting.com\/author\/sydney\/"},"_links":{"self":[{"href":"https:\/\/casusconsulting.com\/wp-json\/wp\/v2\/posts\/6625"}],"collection":[{"href":"https:\/\/casusconsulting.com\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/casusconsulting.com\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/casusconsulting.com\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/casusconsulting.com\/wp-json\/wp\/v2\/comments?post=6625"}],"version-history":[{"count":114,"href":"https:\/\/casusconsulting.com\/wp-json\/wp\/v2\/posts\/6625\/revisions"}],"predecessor-version":[{"id":11538,"href":"https:\/\/casusconsulting.com\/wp-json\/wp\/v2\/posts\/6625\/revisions\/11538"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/casusconsulting.com\/wp-json\/wp\/v2\/media\/6760"}],"wp:attachment":[{"href":"https:\/\/casusconsulting.com\/wp-json\/wp\/v2\/media?parent=6625"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/casusconsulting.com\/wp-json\/wp\/v2\/categories?post=6625"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/casusconsulting.com\/wp-json\/wp\/v2\/tags?post=6625"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}