{"id":9994,"date":"2022-03-29T10:51:20","date_gmt":"2022-03-29T10:51:20","guid":{"rendered":"https:\/\/www.kolabtree.com\/blog\/?p=9994"},"modified":"2023-02-15T11:33:54","modified_gmt":"2023-02-15T11:33:54","slug":"ivdr-compliance-10-tips-for-medical-device-manufacturers","status":"publish","type":"post","link":"https:\/\/www.kolabtree.com\/blog\/ivdr-compliance-10-tips-for-medical-device-manufacturers\/","title":{"rendered":"IVDR compliance: 10 tips for medical device manufacturers"},"content":{"rendered":"<div id=\"ez-toc-container\" class=\"ez-toc-v2_0_45_1 counter-flat ez-toc-counter ez-toc-grey ez-toc-container-direction\">\n<div class=\"ez-toc-title-container\">\n<p class=\"ez-toc-title\">Table of Contents<\/p>\n<span class=\"ez-toc-title-toggle\"><a href=\"#\" class=\"ez-toc-pull-right ez-toc-btn ez-toc-btn-xs ez-toc-btn-default ez-toc-toggle\" area-label=\"ez-toc-toggle-icon-1\"><label for=\"item-69f7748a02948\" aria-label=\"Table of Content\"><span style=\"display: flex;align-items: center;width: 35px;height: 30px;justify-content: center;direction:ltr;\"><svg style=\"fill: #999;color:#999\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\" class=\"list-377408\" width=\"20px\" height=\"20px\" viewBox=\"0 0 24 24\" fill=\"none\"><path d=\"M6 6H4v2h2V6zm14 0H8v2h12V6zM4 11h2v2H4v-2zm16 0H8v2h12v-2zM4 16h2v2H4v-2zm16 0H8v2h12v-2z\" fill=\"currentColor\"><\/path><\/svg><svg style=\"fill: #999;color:#999\" class=\"arrow-unsorted-368013\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\" width=\"10px\" height=\"10px\" viewBox=\"0 0 24 24\" version=\"1.2\" baseProfile=\"tiny\"><path d=\"M18.2 9.3l-6.2-6.3-6.2 6.3c-.2.2-.3.4-.3.7s.1.5.3.7c.2.2.4.3.7.3h11c.3 0 .5-.1.7-.3.2-.2.3-.5.3-.7s-.1-.5-.3-.7zM5.8 14.7l6.2 6.3 6.2-6.3c.2-.2.3-.5.3-.7s-.1-.5-.3-.7c-.2-.2-.4-.3-.7-.3h-11c-.3 0-.5.1-.7.3-.2.2-.3.5-.3.7s.1.5.3.7z\"\/><\/svg><\/span><\/label><input  type=\"checkbox\" id=\"item-69f7748a02948\"><\/a><\/span><\/div>\n<nav><ul class='ez-toc-list ez-toc-list-level-1 ' ><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-1\" href=\"https:\/\/www.kolabtree.com\/blog\/ivdr-compliance-10-tips-for-medical-device-manufacturers\/#What_is_the_IVDR\" title=\"What is the IVDR?\">What is the IVDR?<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-2\" href=\"https:\/\/www.kolabtree.com\/blog\/ivdr-compliance-10-tips-for-medical-device-manufacturers\/#1_Preparing_for_IVDR_compliance_and_commercial_changes\" title=\"1. Preparing for IVDR compliance and commercial changes\">1. Preparing for IVDR compliance and commercial changes<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-3\" href=\"https:\/\/www.kolabtree.com\/blog\/ivdr-compliance-10-tips-for-medical-device-manufacturers\/#2_Clear_understanding_of_the_classification\" title=\"2. Clear understanding of the classification\">2. Clear understanding of the classification<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-4\" href=\"https:\/\/www.kolabtree.com\/blog\/ivdr-compliance-10-tips-for-medical-device-manufacturers\/#3_Involvement_of_notified_body\" title=\"3. Involvement of notified body\u00a0\">3. Involvement of notified body\u00a0<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-5\" href=\"https:\/\/www.kolabtree.com\/blog\/ivdr-compliance-10-tips-for-medical-device-manufacturers\/#4_Establishment_of_quality_management_system_QMS\" title=\"4. Establishment of quality management system (QMS)\">4. Establishment of quality management system (QMS)<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-6\" href=\"https:\/\/www.kolabtree.com\/blog\/ivdr-compliance-10-tips-for-medical-device-manufacturers\/#5_Be_prepared_for_disruption_in_the_supply_chain\" title=\"5. Be prepared for disruption in the supply chain\">5. Be prepared for disruption in the supply chain<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-7\" href=\"https:\/\/www.kolabtree.com\/blog\/ivdr-compliance-10-tips-for-medical-device-manufacturers\/#6_Ensuring_audit_and_inspection_readiness\" title=\"6. Ensuring audit and inspection readiness\">6. Ensuring audit and inspection readiness<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-8\" href=\"https:\/\/www.kolabtree.com\/blog\/ivdr-compliance-10-tips-for-medical-device-manufacturers\/#7_Plan_to_handle_unannounced_audits\" title=\"7. Plan to handle unannounced audits\">7. Plan to handle unannounced audits<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-9\" href=\"https:\/\/www.kolabtree.com\/blog\/ivdr-compliance-10-tips-for-medical-device-manufacturers\/#8_Strengthen_post-market_surveillance_activities\" title=\"8.\u00a0 Strengthen post-market surveillance activities\">8.\u00a0 Strengthen post-market surveillance activities<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-10\" href=\"https:\/\/www.kolabtree.com\/blog\/ivdr-compliance-10-tips-for-medical-device-manufacturers\/#9_Unique_device_identifier_UDI_EUDAMED\" title=\"9. Unique device identifier (UDI) &amp; EUDAMED\">9. Unique device identifier (UDI) &amp; EUDAMED<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-11\" href=\"https:\/\/www.kolabtree.com\/blog\/ivdr-compliance-10-tips-for-medical-device-manufacturers\/#10_Requirements_for_in-house_devices\" title=\"10.\u00a0 Requirements for &#8220;in-house devices&#8221;\">10.\u00a0 Requirements for &#8220;in-house devices&#8221;<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-12\" href=\"https:\/\/www.kolabtree.com\/blog\/ivdr-compliance-10-tips-for-medical-device-manufacturers\/#References\" title=\"References\">References<\/a><\/li><\/ul><\/nav><\/div>\n<p><em>An exhaustive guide to regulatory compliance for IVD manufacturers, written by <a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/sundeep-agarwal\/?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=IVDRCompliance\">Sundeep Agarwal<\/a>, experienced <a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/subject\/ivdr?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=IVDR-compliance\">IVDR consultant<\/a>.\u00a0<\/em><\/p>\n<h2><span class=\"ez-toc-section\" id=\"What_is_the_IVDR\"><\/span>What is the IVDR?<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p>The European Commission&#8217;s (EC) In Vitro Diagnostic Regulation (EU IVDR 2017\/746) is a \u2018legislative framework\u2019 and a way forward towards global IVD safety, which assures that only reliable and effective IVDs are in the market. The European Commission is trying its best to make the <a href=\"https:\/\/www.kolabtree.com\/blog\/ensuring-reproducibility-in-ai-driven-research-how-freelance-experts-can-help-in-biotech-and-healthcare\/\">healthcare<\/a> system safer and error free in terms of diagnosis or outcomes.<\/p>\n<p><strong>The in vitro diagnostic medical devices<\/strong> (<strong>IVDD), 98\/79\/EC was a directive while IVDR is a legislation (regulation) applicable to all Economic Operator (EO) i.e., manufacturers, importers, users, notified bodies and national authorities in the European Economic Area (EEA) and those non-EU-manufacturer and suppliers placing or planning to distribute IVD in the European market. <\/strong><\/p>\n<p>IVDR consist of 113 articles (10 chapters) and fifteen annexures in comparison to 24 articles, ten annexures of IVDD. No doubt, IVDR is a lengthy piece of regulation and considerably stringent but then the good part is that, it is more transparent with the regulatory changes and requirements.<\/p>\n<p>It emphasizes on life cycle-based approach. It will be applied from 26 May 2022 and economic operators (including non-EU manufacturer) are expected to proactively prepare themselves towards planning and implementation of the same. Every stakeholder in the process shall now be equally responsible for the European Economic Area (EEA) in-vitro diagnostics market.<\/p>\n<ul>\n<li>The first and foremost thing an organization should do is to organize training program (online or onsite, as applicable) on EU IVDR so that everyone in the organization is aware of the necessary changes.<\/li>\n<li>An official communication should be followed by, to all the supplier, sub-contractors, or service provider about the process and their obligations.<\/li>\n<li>Perform a gap assessment to check the availability of their resources, a competent team to update the technical documentation required under EU IVDR. Being ISO 13485: 2016 certified would be an added advantage to establish compliance.<\/li>\n<li>It is advisable (If needed) to engage a subject matter expert or an external consultant from the very early stage of transition because \u2018a stitch in time saves nine\u2019.<\/li>\n<li>This blog will provide a detail outline and practical tips to comply with the expectation by the notified bodies and competent authorities as described in the various articles and annexures under EU IVDR 2017\/746.<\/li>\n<\/ul>\n<p><img decoding=\"async\" loading=\"lazy\" class=\"alignnone size-full wp-image-9995\" src=\"https:\/\/www.kolabtree.com\/blog\/wp-content\/uploads\/2022\/03\/Figure1.jpg\" alt=\"\" width=\"1622\" height=\"980\" srcset=\"https:\/\/www.kolabtree.com\/blog\/wp-content\/uploads\/2022\/03\/Figure1.jpg 1622w, https:\/\/www.kolabtree.com\/blog\/wp-content\/uploads\/2022\/03\/Figure1-300x181.jpg 300w, https:\/\/www.kolabtree.com\/blog\/wp-content\/uploads\/2022\/03\/Figure1-1024x619.jpg 1024w, https:\/\/www.kolabtree.com\/blog\/wp-content\/uploads\/2022\/03\/Figure1-1536x928.jpg 1536w, https:\/\/www.kolabtree.com\/blog\/wp-content\/uploads\/2022\/03\/Figure1-16x10.jpg 16w, https:\/\/www.kolabtree.com\/blog\/wp-content\/uploads\/2022\/03\/Figure1-300x181@2x.jpg 600w\" sizes=\"(max-width: 1622px) 100vw, 1622px\" \/><\/p>\n<p>&nbsp;<\/p>\n<p>Figure1: IVDD vs. IVDR<\/p>\n<h2><span class=\"ez-toc-section\" id=\"1_Preparing_for_IVDR_compliance_and_commercial_changes\"><\/span>1. Preparing for IVDR compliance and commercial changes<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p><em>The foremost business decision for an organization would be to conclude if they want to continue to place their IVD in the European Economic Area (EEA). If the answer is \u2018yes\u2019, then one has should obtain estimates (cost), timelines, scope of audit, product code, etc. from a NB at the earliest possible. A shift from a directive to regulation calls for a mandatory compliance and robust technical documentation to establish safety and efficacy and to achieve CE Certification. <\/em>IVDR largely relies a lot more on the clinical evidences <em>i.e., scientific validity, analytical performance and clinical performance <\/em>to establish the safety and efficacy.<\/p>\n<p><strong>The involvement of a notified body (NB) in the process of CE certification will be a prominent feature of the regulation. This also indicates an additional investment for the economic operator which may indirectly increase the cost of product.<\/strong><\/p>\n<p>An appointment of a <strong><em>\u201cPerson responsible for regulatory compliance (PRRC)\u201d <\/em><\/strong>in accordance with Article 15 of EU IVDR 2017\/746 is now mandatory; who shall assure the conformity of QMS, declaration of conformity, technical documentation, post market surveillance and reporting of adverse events are in compliance to EU IVDR.Manufacturers should ensure that the entire transition (including new certification application) is completed before the expiry of their existing IVDD Certificate or Self-certified Declaration of conformity. Certificates issued by notified bodies in accordance with IVDD 98\/79\/EC from 25 May 2017 shall become invalid after 27 May 2024. Be aware of the new timeline for application as per the EC official press release [1] dtd.20<sup>th<\/sup> December 2022.<\/p>\n<h2><span class=\"ez-toc-section\" id=\"2_Clear_understanding_of_the_classification\"><\/span>2. Clear understanding of the classification<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p>Reconsider the new classification rule under Annex VIII of IVDR and check if it has affected your previous classification.<\/p>\n<blockquote><p><em>Performing a correct classification is essential before preparing for the CE certification process. Unless we are able to do so, the conformity route will be unclear and delays or invalidate our efforts to comply with IVDR requirements.<\/em><\/p><\/blockquote>\n<p>IVDR is a <strong>risk-based approach<\/strong> to classify device with increased notified body and competent authority controls. The Regulation identifies <strong>four risk classes<\/strong>: Class A (lowest risk), Class B, Class C, and Class D (highest risk) while Annex VIII define <strong>seven <\/strong><strong>classification rules<\/strong> to correctly classify the products. A unique feature of the IVDR is that, Software is also classified under Implementing rule 1.4 of Annex VIII, which states \u201cSoftware, which drives a device or influences the use of a device, shall fall within the same class as the device. If the software is independent of any other device, it shall be classified in its own right<a href=\"#_ftn2\" name=\"_ftnref2\">[2]<\/a>\u201d. This indicates the scope for Software to be regulated under IVDR. And manufacturer has to also perform software verification and validation (Annex II, 6.4) accordingly.<\/p>\n<p><img decoding=\"async\" loading=\"lazy\" class=\"alignnone size-full wp-image-9997\" src=\"https:\/\/www.kolabtree.com\/blog\/wp-content\/uploads\/2022\/03\/Figure2-1.jpg\" alt=\"\" width=\"1160\" height=\"697\" srcset=\"https:\/\/www.kolabtree.com\/blog\/wp-content\/uploads\/2022\/03\/Figure2-1.jpg 1160w, https:\/\/www.kolabtree.com\/blog\/wp-content\/uploads\/2022\/03\/Figure2-1-300x180.jpg 300w, https:\/\/www.kolabtree.com\/blog\/wp-content\/uploads\/2022\/03\/Figure2-1-1024x615.jpg 1024w, https:\/\/www.kolabtree.com\/blog\/wp-content\/uploads\/2022\/03\/Figure2-1-16x10.jpg 16w, https:\/\/www.kolabtree.com\/blog\/wp-content\/uploads\/2022\/03\/Figure2-1-300x180@2x.jpg 600w\" sizes=\"(max-width: 1160px) 100vw, 1160px\" \/><\/p>\n<p>Figure 2: Risk Based Classification under IVDR 2107\/746<\/p>\n<h2><span class=\"ez-toc-section\" id=\"3_Involvement_of_notified_body\"><\/span><strong>3. Involvement of notified body\u00a0<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p><em>The role of a notified body (NB) would be one of the core elements and hence a larger number of manufacturers would now require to be audited and certified by a notified body vis-\u00e0-vis traditional method of \u201cself-certification\u201d.<\/em>Economic Operators should carefully decide on the conformity assessment route (Annex IX, X, XI of EU IVDR<a href=\"#_ftn3\" name=\"_ftnref3\">[3]<\/a>).<\/p>\n<p>IVDR not only demands additional investment but has to assure that their technical documentation and quality management system meets the new requirements of IVDR. Under the IVDD, most of the IVDs are self-certified (92%), and do not require the involvement of a Notified Body (except 8% of the total IVD place in the market[4]). While under the new IVDR, the scenario is not the same.<\/p>\n<p>According to a study <em>\u201cThe impact of the new European IVD-classification rules on the notified body involvement\u201d by National Institute for Public Health and the Environment, Bilthoven (Netherlands) RIVM Letter report 2018-0082, A. van Drongelen et al., nearly 85% of all IVDs will be requiring Notified Body involvement, leaving only 15% of IVDs eligible for self-certification[5]<\/em>.<\/p>\n<p>This also means In Vitro Diagnostics (IVDs) manufacturer will now experience a major shift to comply with the new classification and certification process.\u00a0 Further depending on the intended use of the devices and risks class, manufacturer need to identify a designated NB which who might be able to audit them and get their products certified. Highest risk IVD (Class-D) would require EU reference lab, or expert panels to verify the performance claim additionally to the involvement of a Notified Body(NB) or Competent Authority (CA). Currently there only six notified bodies designated under EU IVDR. Do not wait to start your application process to avoid unexpected delays due to unavailability of a Notified Body.<\/p>\n<p><img decoding=\"async\" loading=\"lazy\" class=\"alignnone size-full wp-image-9998\" src=\"https:\/\/www.kolabtree.com\/blog\/wp-content\/uploads\/2022\/03\/Figure3-1.jpg\" alt=\"\" width=\"1583\" height=\"714\" srcset=\"https:\/\/www.kolabtree.com\/blog\/wp-content\/uploads\/2022\/03\/Figure3-1.jpg 1583w, https:\/\/www.kolabtree.com\/blog\/wp-content\/uploads\/2022\/03\/Figure3-1-300x135.jpg 300w, https:\/\/www.kolabtree.com\/blog\/wp-content\/uploads\/2022\/03\/Figure3-1-1024x462.jpg 1024w, https:\/\/www.kolabtree.com\/blog\/wp-content\/uploads\/2022\/03\/Figure3-1-1536x693.jpg 1536w, https:\/\/www.kolabtree.com\/blog\/wp-content\/uploads\/2022\/03\/Figure3-1-16x7.jpg 16w, https:\/\/www.kolabtree.com\/blog\/wp-content\/uploads\/2022\/03\/Figure3-1-300x135@2x.jpg 600w\" sizes=\"(max-width: 1583px) 100vw, 1583px\" \/><\/p>\n<p>Figure 3: List of designated notified body under IVDR[6]\n<h2><span class=\"ez-toc-section\" id=\"4_Establishment_of_quality_management_system_QMS\"><\/span>4. Establishment of quality management system (QMS)<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p><em>IVD manufacturers are expected to establish a robust and reliable quality management system (QMS) within their premises. It\u2019s a general obligation of a manufacturer under Article 10 of IVDR<\/em>. Quality management system is one essential requirement among various other, without which a manufacturer won\u2019t be able to get approved.<\/p>\n<p>QMS is to ensure that manufacturing, change control, customer complaints, resource management, supplier &amp;sub-contractors\u2019 controls and validation, performance evaluation, quality test, UDI Labelling, Post market surveillance etc. are according to approved QMS and Post Market Surveillance (PMS) plans.<\/p>\n<p>The PRRC has to ensure the manufacturer has met the requirements of Article 10 to \u201cself-certify\u201d (issuance of Declaration of conformity in accordance with Annex IV) Class A IVD when a Notified Body (NB) is not required in the process.<\/p>\n<h2><span class=\"ez-toc-section\" id=\"5_Be_prepared_for_disruption_in_the_supply_chain\"><\/span><strong>5. Be prepared for disruption in the supply chain<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p>Throughout the world, manufacturer depends largely on their supply chain and raw material to produce and deliver IVDs that are safe, accurate, and effective forthe intended use. Hence regulatory and quality concerns are also evolving to a higher level when it comes to the suppliers and sub-contractors\u2019 controls. Manufacturer are therefore expected to proactively communicate the supply chain about their obligations and responsibilities of the suppliers and subcontractors. Legal manufacturer shall demonstrate adequate supplier control and monitoring, assure the supply chain is in compliance to the regulatory aspects of IVDR, reconsider the need for data integrity and quality of supplier data, implement robust supplier risk management and performance monitoring and periodically audit the supplier based on the associated risk to the finished products. <strong><em>The regulators and notified bodies are emphasizing on the legal manufacturers to clearly document the level of supplier controls and demonstrate with evidence that they have the potential to mitigate the risk of the product or service provided by the supplier. <\/em><\/strong><\/p>\n<h2><span class=\"ez-toc-section\" id=\"6_Ensuring_audit_and_inspection_readiness\"><\/span>6. Ensuring audit and inspection readiness<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p>According to Article 88 of IVDR, Market Surveillance Activities, Competent authorities shall carry out both announced (unannounced) inspections on the premises of economic operators as well as suppliers and\/or subcontractors and when necessary, at the facilities of professional users. While manufacturer shall include information on identification of all sites, including suppliers and sub-contractors, where manufacturing activities are performed in the Technical Documentation of Design &amp; Manufacturing information. Notified bodies (NB) performing QMS audit shall identify links between and allocation of responsibilities among the various manufacturing sites, and their suppliers and\/or subcontractors. This information will be considered while the NB specifically wants to audit any of those suppliers or subcontractors or both. <strong>The premises of the manufacturer&#8217;s suppliers, when considered to be significantly affecting the conformity of finished devices shall be essentially audited by the NB (in particular when the manufacturer cannot demonstrate sufficient control over its suppliers).<\/strong><\/p>\n<h2><span class=\"ez-toc-section\" id=\"7_Plan_to_handle_unannounced_audits\"><\/span>7. Plan to handle unannounced audits<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p>Under post-certification monitoring, the NB shall proceed with unannounced on-site audits of manufacturers and their subcontractors or suppliers carrying out product tests and the monitoring of compliance with any conditions binding manufacturers and associated with certification decisions, such as updates to clinical data at defined intervals.<strong><em>Further, t<\/em><\/strong><strong><em>he notified body shall randomly perform at least once every five years unannounced audits on the site of the manufacturer and, where appropriate, the site of the manufacturer&#8217;s suppliers and\/or subcontractors, which may be combined with the periodic surveillance assessment.<\/em><\/strong><\/p>\n<h2><span class=\"ez-toc-section\" id=\"8_Strengthen_post-market_surveillance_activities\"><\/span>8.\u00a0 Strengthen post-market surveillance activities<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p>Manufacturers are strongly recommended to strengthen their post-market surveillance requirements and develop mechanism to coordinate between EU member states on vigilance and market surveillance. Under surveillance assessment applicable to class C and class D devices (Annex IX), the notified body shall periodically, at least once every 12 months, carry out appropriate audits and assessments. It shall include audits on the premises of the manufacturer and suppliers and\/or subcontractors as applicable. Manufacturer shall essentially develop a procedure for recording and reporting of incidents and Field Safety Corrective Action (FSCA).<\/p>\n<h2><span class=\"ez-toc-section\" id=\"9_Unique_device_identifier_UDI_EUDAMED\"><\/span>9. Unique device identifier (UDI) &amp; EUDAMED<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p>Manufacturer shall have to establish a system for UDI to identify and facilitate traceability of devices. \u2018Device Identifier\u2019 and \u2018Production identifier\u2019 shall be on the labels to enhance traceability in EU market.One may refer to a list of accredited issuing Entity (IE) such as GS1, HIBCC, ICCBBA, IFA GmbH to operate a system for the assignment of UDIs. Currently the mentioned IEs are valid from 27<sup>th<\/sup> June 2019, but it will be wise to confirm their validity while making a final decision on implementing them.<\/p>\n<p>European Database on Medical Devices (EUDAMED) will provide an overview of all medical devices available in the European Union. It consist of six modules related to:<\/p>\n<ol>\n<li>Actor registration,<\/li>\n<li>Unique device identification (UDI) and device registration,<\/li>\n<li>Notified bodies and certificates,<\/li>\n<li>Clinical investigations and performance studies,<\/li>\n<li>Vigilance and Post market surveillance, and<\/li>\n<li>Market surveillance.<\/li>\n<\/ol>\n<p>To ensure an improved transparency through a comprehensive EUDAMED, parts of Economic Operators information will be publicly accessible. While confidential information will be accessible only to Economic Operator, Sponsors, Notified and Competent Authorities of EU member states.<\/p>\n<h2><span class=\"ez-toc-section\" id=\"10_Requirements_for_in-house_devices\"><\/span>10.\u00a0 Requirements for &#8220;in-house devices&#8221;<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p>Health institution developing &#8216;in-house devices&#8217; (or \u2018laboratory-developed tests&#8217;) which are meant to be used by the same health institution shall not be marketed or sold to other legal entity. Such devices may be used for the diagnosis and treatment, especially for rare diseases. The institution is expected to comply with only the requirement of\u00a0 Annex I of IVDR (general safety and performance requirements), and exempted from rest of the regulation until 26 May 2024; provided the health institution meets a number of conditions set out in Article 5(5) of the Regulation and has an appropriate quality management system, which complies to the international standard setting out the quality and competence requirements for medical laboratories (EN ISO 15189) or other national provisions, and is able to justify that target patient group&#8217;s specific needs cannot appropriately be met by an equivalent device available on the market.<\/p>\n<h2><span class=\"ez-toc-section\" id=\"References\"><\/span>References<span class=\"ez-toc-section-end\"><\/span><\/h2>\n[1] EC official press release dtd. 20<sup>th<\/sup> Dec 2021, Progressive roll-out of the In Vitro Diagnostic Medical Devices Regulation. Can be accessed at <a href=\"https:\/\/ec.europa.eu\/commission\/presscorner\/detail\/en\/IP_21_6965\">https:\/\/ec.europa.eu\/commission\/presscorner\/detail\/en\/IP_21_6965<\/a><\/p>\n[2]REGULATION (EU) 2017\/746 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98\/79\/EC and Commission Decision 2010\/227\/EU; ANNEX<em> VIII <\/em>CLASSIFICATION RULES, 1. IMPLEMENTING RULES Point 1.4 Page 304<\/p>\n[3]Regulation (EU) 2017\/746 of the European parliament and of the council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98\/79\/EC and Commission Decision 2010\/227\/EU<\/p>\n<p>ANNEX IX Conformity Assessment Based On A Quality Management System And On Assessment Of Technical Documentation, Page 306, ANNEX X Conformity Assessment Based On Type-Examination, Page 314, ANNEX XI Conformity Assessment Based On Production Quality Assurance, Page 317<\/p>\n[4] Press release dtd. 14 October 2021, Brussels; Public health: Commission proposes a progressive roll-out of the new In Vitro Diagnostic Medical Devices Regulation<\/p>\n[5]The impact of the new European IVD-classification rules on the notified body involvement; : a study on the IVDs registered in the Netherlands; <em>van Drongelen A, de Bruijn A, Pennings J, van der Maaden T <\/em>32 p in English\u00a0\u00a0 2018, RIVM letter report 2018-0082<\/p>\n[6] The above list is based on data accessed dtd. 5th March 2021, for the latest updates on the list, you may access the official website of EC at <a href=\"https:\/\/ec.europa.eu\/growth\/tools-databases\/nando\/index.cfm?fuseaction=directive.notifiedbody&amp;dir_id=35\">https:\/\/ec.europa.eu\/growth\/tools-databases\/nando\/index.cfm?fuseaction=directive.notifiedbody&amp;dir_id=35<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>An exhaustive guide to regulatory compliance for IVD manufacturers, written by Sundeep Agarwal, experienced IVDR consultant.\u00a0 What is the IVDR? The European Commission&#8217;s (EC) In Vitro Diagnostic Regulation (EU IVDR 2017\/746) is a \u2018legislative framework\u2019 and a way forward towards global IVD safety, which assures that only reliable and effective IVDs are in the market.<\/p>\n<div class=\"read-more\"><a href=\"https:\/\/www.kolabtree.com\/blog\/ivdr-compliance-10-tips-for-medical-device-manufacturers\/\" title=\"Read More\">Read More<\/a><\/div>\n","protected":false},"author":12,"featured_media":10000,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":[],"categories":[540],"tags":[],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v20.1 (Yoast SEO v20.1) - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>IVDR compliance: 10 tips for medical device manufacturers<\/title>\n<meta name=\"description\" content=\"An exhaustive guide to IVDR compliance, sourced from an experienced regulatory consultant. 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