{"id":60646,"date":"2025-01-17T13:02:39","date_gmt":"2025-01-17T12:02:39","guid":{"rendered":"https:\/\/pharma-trend.com\/en\/the-role-of-the-person-responsible-for-regulatory-compliance-prrc-under-the-mdr-medical-device-regulation-2017-745-and-ivdr-in-vitro-diagnostic-regulation-2017-746-training-course-researchandm\/"},"modified":"2025-01-17T13:02:39","modified_gmt":"2025-01-17T12:02:39","slug":"the-role-of-the-person-responsible-for-regulatory-compliance-prrc-under-the-mdr-medical-device-regulation-2017-745-and-ivdr-in-vitro-diagnostic-regulation-2017-746-training-course-researchandm","status":"publish","type":"post","link":"https:\/\/pharma-trend.com\/en\/the-role-of-the-person-responsible-for-regulatory-compliance-prrc-under-the-mdr-medical-device-regulation-2017-745-and-ivdr-in-vitro-diagnostic-regulation-2017-746-training-course-researchandm\/","title":{"rendered":"The Role of the Person Responsible for Regulatory Compliance (PRRC) Under the MDR (Medical Device Regulation 2017\/745) and IVDR (In-Vitro Diagnostic Regulation 2017\/746) Training Course &#8211; ResearchAndMarkets.com"},"content":{"rendered":"<div>\n<p>DUBLIN&#8211;(BUSINESS WIRE)&#8211;The <a target=\"_blank\" href=\"https:\/\/www.researchandmarkets.com\/reports\/6034550\/the-role-the-person-responsible-regulatory?utm_source=BW&amp;utm_medium=PressRelease&amp;utm_code=s3n52b&amp;utm_campaign=2027746+-+The+Role+of+the+Person+Responsible+for+Regulatory+Compliance+(PRRC)+Under+the+MDR+(Medical+Device+Regulation+2017%2F745)+and+IVDR+(In-Vitro+Diagnostic+Regulation+2017%2F746)+Training+Course&amp;utm_exec=chdomspi\" rel=\"nofollow\" shape=\"rect\">&#8220;The Role of the Person Responsible for Regulatory Compliance (PRRC) Under the MDR (Medical Device Regulation) and IVDR (In-Vitro Diagnostic Regulation) Training Course&#8221;<\/a> conference has been added to <strong>ResearchAndMarkets.com&#8217;s<\/strong> offering.<\/p>\n<p><a href=\"https:\/\/mms.businesswire.com\/media\/20250117897448\/en\/2356317\/4\/logo.jpg\"><img decoding=\"async\" src=\"https:\/\/mms.businesswire.com\/media\/20250117897448\/en\/2356317\/22\/logo.jpg\"><\/a><br \/><a href=\"https:\/\/mms.businesswire.com\/media\/20250117897448\/en\/2356317\/4\/logo.jpg\"><img decoding=\"async\" src=\"https:\/\/mms.businesswire.com\/media\/20250117897448\/en\/2356317\/21\/logo.jpg\"><\/a><\/p>\n<p>\nAttend this one-day course to gain a comprehensive understanding of the critical role of the Person Responsible for Regulatory Compliance (PRRC) introduced by the Medical Device Regulation 2017\/745 and the In-Vitro Diagnostic Device Regulation 2017\/746<\/p>\n<p>\nIn the evolving landscape of medical device regulation, understanding and complying with new roles and requirements is crucial for maintaining market access and ensuring patient safety. The introduction of the Person Responsible for Regulatory Compliance (PRRC) role mandated under the Medical Device Regulation (MDR) 2017\/745 and the In-vitro Diagnostic Device Regulation (IVDR) 2017\/746 has created a pivotal position within organisations, necessitating a deep understanding of its responsibilities and integration into existing systems.<\/p>\n<p>\nThis course is designed to address these challenges and provide participants with the necessary knowledge and tools to effectively implement the PRRC role within their organisations.<\/p>\n<p>\nThis comprehensive one-day course will delve into Article 15 of the regulation in detail, ensuring a thorough understanding of each requirement&#8217;s intent. Participants will also be briefed on the UK MDR requirements and the proposed Qualified Person (QP) role, based on the latest information.<\/p>\n<p>\nA key focus will be the integration of the PRRC role into the Quality Management System, supported by real-world examples to illustrate practical applications. The course will explore the provision of PRRC services by third parties, addressing how to meet all requirements remotely from the manufacturer.<\/p>\n<p>\nThis course offers an excellent opportunity to grasp the significance of the PRRC role and its critical place in your organisation, equipping you with the insights and practical strategies to ensure compliance and regulatory success.<\/p>\n<p>\n<strong>Who Should Attend:<\/strong><\/p>\n<p>\nThis course is ideal for those seeking to understand the role of the Person Responsible for Regulatory Compliance (PRRC), and those currently holding or considering the PRRC designation within medical device companies, including:<\/p>\n<ul>\n<li>\nQuality managers\/specialists<\/li>\n<li>\nRegulatory affairs professionals<\/li>\n<li>\nStart-up organisations with a need to understand where the PRRC role is required<\/li>\n<li>\nCompliance engineers<\/li>\n<li>\nMedical device manufacturers<\/li>\n<li>\nThose considering undertaking the PRRC role<\/li>\n<\/ul>\n<p>\n<strong>Benefits of Attending<\/strong><\/p>\n<ul>\n<li>\n<strong>Understand<\/strong> the role and responsibilities of the PRRC<\/li>\n<li>\n<strong>Identify <\/strong>ways of incorporating the PRRC role into your organisation and Quality Management System<\/li>\n<li>\n<strong>Compare<\/strong> the EU PRRC role with the proposed UK MDR Qualified Person role<\/li>\n<li>\n<strong>Gain<\/strong> a clearer understanding of the PRRC role for those considering whether they should undertake this<\/li>\n<\/ul>\n<p>\n<strong>Certifications:<\/strong><\/p>\n<ul>\n<li>\nCPD: 6 hours for your records<\/li>\n<li>\nCertificate of completion<\/li>\n<\/ul>\n<p>\n<strong>Key Topics Covered:<\/strong><\/p>\n<p>\n<strong>Origins of EU PRRC\/UK QP role<\/strong><\/p>\n<ul>\n<li>\nWhich competent authority drove the need?<\/li>\n<li>\nWhy was the role introduced?<\/li>\n<li>\nWhat was the gap that needed to be filled?<\/li>\n<\/ul>\n<p>\n<strong>Article 15<\/strong><\/p>\n<ul>\n<li>\nRequirements<\/li>\n<li>\nQualifications<\/li>\n<li>\nImporters, distributors<\/li>\n<li>\nSystems and Procedure Packs<\/li>\n<li>\nAuthorised representatives<\/li>\n<\/ul>\n<p>\n<strong>UK MDR 2002<\/strong><\/p>\n<ul>\n<li>\nWhat does the response from the UK tell us?<\/li>\n<li>\nDifferences from the EU<\/li>\n<\/ul>\n<p>\n<strong>PRRC roles and responsibilities<\/strong><\/p>\n<ul>\n<li>\nThe conformity device meets regulatory standards<\/li>\n<li>\nTechnical documentation is established and maintained<\/li>\n<li>\nPost-market surveillance activities are compliant with regulations<\/li>\n<li>\nIncidents are recorded and reported and field safety corrective actions are implemented<\/li>\n<li>\nA statement has been issued in case of investigational devices (MDR) or IVD devices intended for use in interventional clinical effectiveness studies (IVDR)<\/li>\n<\/ul>\n<p>\n<strong>Case Study: Who should be a PRRC?<\/strong><\/p>\n<p>\n<strong>PRRC Quality Management System Integration<\/strong><\/p>\n<ul>\n<li>\nJob descriptions<\/li>\n<li>\nSOP to cover appointments and cover<\/li>\n<li>\nProof for audits etc<\/li>\n<\/ul>\n<p>\n<strong>Provision of PRRC service by third parties<\/strong><\/p>\n<ul>\n<li>\nWhat does the regulation state?<\/li>\n<li>\nHow does an organisation qualify as small or medium?<\/li>\n<li>\nPracticalities of access for third parties<\/li>\n<\/ul>\n<p>\n<strong>Overview of key take home points<\/strong><\/p>\n<p>\n<strong>Final score assessment<\/strong><\/p>\n<p>\n<strong>Assessment review workshop<\/strong><\/p>\n<ul>\n<li>\nA short questionnaire to aid the learning process<\/li>\n<\/ul>\n<p>\n<strong>Speakers:<\/strong><\/p>\n<p>\nStuart Angell<\/p>\n<p>\nDirector<\/p>\n<p>\nIVDeology Ltd<\/p>\n<p>\nStuart Angell, This MDTI expert is a joint director in his own consultancy specialising in global regulatory affairs strategy and compliance for in vitro diagnostics and medical devices focusing on the transition to the new IVD\/Medical Device Regulations, MDSAP and ISO13485:2016.<\/p>\n<p>\nHe has over 15 years in the IVD industry and in previous roles has been responsible for designing, reviewing and maintaining regulatory frameworks for self-declared and annex list II products including technical documentation for EU and global submissions (FDA, Health Canada, TGA, Russia, Latin America). He has an excellent understanding of risk management, Post Market Surveillance (PMS) and vigilance.<\/p>\n<p>\nFor more information about this conference visit <a target=\"_blank\" href=\"https:\/\/www.researchandmarkets.com\/reports\/6034550\/the-role-the-person-responsible-regulatory?utm_source=BW&amp;utm_medium=PressRelease&amp;utm_code=s3n52b&amp;utm_campaign=2027746+-+The+Role+of+the+Person+Responsible+for+Regulatory+Compliance+(PRRC)+Under+the+MDR+(Medical+Device+Regulation+2017%2F745)+and+IVDR+(In-Vitro+Diagnostic+Regulation+2017%2F746)+Training+Course&amp;utm_exec=chdomspi\" rel=\"nofollow\" shape=\"rect\">https:\/\/www.researchandmarkets.com\/r\/d91i7s<\/a><\/p>\n<p>\n<strong>About ResearchAndMarkets.com<\/strong><\/p>\n<p>\nResearchAndMarkets.com is the world&#8217;s leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends.<\/p>\n<p> <b>Contacts<\/b> <\/p>\n<p>\nResearchAndMarkets.com<br \/>\n<br \/>Laura Wood, Senior Press Manager<br \/>\n<br \/><a target=\"_blank\" href=\"m&#97;&#x69;&#x6c;&#x74;o&#58;&#112;&#x72;&#x65;s&#115;&#64;&#x72;&#x65;se&#97;&#x72;&#x63;&#x68;a&#110;&#x64;&#x6d;&#x61;r&#107;&#101;&#x74;&#x73;&#46;&#99;&#111;&#x6d;\" rel=\"nofollow\" shape=\"rect\">&#112;r&#x65;s&#x73;&#64;&#x72;&#101;&#x73;&#101;a&#x72;c&#x68;&#97;&#x6e;&#100;&#x6d;&#97;&#x72;&#107;e&#x74;s&#x2e;&#99;&#x6f;&#109;<\/a><\/p>\n<p>For E.S.T Office Hours Call 1-917-300-0470<br \/>\n<br \/>For U.S.\/ CAN Toll Free Call 1-800-526-8630<br \/>\n<br \/>For GMT Office Hours Call +353-1-416-8900<\/p>\n<\/div>\n","protected":false},"excerpt":{"rendered":"<p>DUBLIN&#8211;(BUSINESS WIRE)&#8211;The &#8220;The Role of the Person Responsible for Regulatory Compliance (PRRC) Under the MDR (Medical Device Regulation) and IVDR (In-Vitro Diagnostic Regulation) Training Course&#8221; conference has been added to ResearchAndMarkets.com&#8217;s offering. Attend this one-day course to gain a comprehensive understanding of the critical role of the Person Responsible for Regulatory Compliance (PRRC) introduced by &#8230; <span class=\"more\"><a class=\"more-link\" href=\"https:\/\/pharma-trend.com\/en\/the-role-of-the-person-responsible-for-regulatory-compliance-prrc-under-the-mdr-medical-device-regulation-2017-745-and-ivdr-in-vitro-diagnostic-regulation-2017-746-training-course-researchandm\/\">[Read more&#8230;]<\/a><\/span><\/p>\n","protected":false},"author":4,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[13],"tags":[],"class_list":{"0":"entry","1":"post","2":"publish","3":"author-business","4":"post-60646","6":"format-standard","7":"category-industry"},"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.3 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>The Role of the Person Responsible for Regulatory Compliance (PRRC) Under the MDR (Medical Device Regulation 2017\/745) and IVDR (In-Vitro Diagnostic Regulation 2017\/746) Training Course - ResearchAndMarkets.com - Pharma Trend<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/pharma-trend.com\/en\/the-role-of-the-person-responsible-for-regulatory-compliance-prrc-under-the-mdr-medical-device-regulation-2017-745-and-ivdr-in-vitro-diagnostic-regulation-2017-746-training-course-researchandm\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"The Role of the Person Responsible for Regulatory Compliance (PRRC) Under the MDR (Medical Device Regulation 2017\/745) and IVDR (In-Vitro Diagnostic Regulation 2017\/746) Training Course - ResearchAndMarkets.com - Pharma Trend\" \/>\n<meta property=\"og:description\" content=\"DUBLIN&#8211;(BUSINESS WIRE)&#8211;The &#8220;The Role of the Person Responsible for Regulatory Compliance (PRRC) Under the MDR (Medical Device Regulation) and IVDR (In-Vitro Diagnostic Regulation) Training Course&#8221; conference has been added to ResearchAndMarkets.com&#8217;s offering. 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conference has been added to ResearchAndMarkets.com&#8217;s offering. Attend this one-day course to gain a comprehensive understanding of the critical role of the Person Responsible for Regulatory Compliance (PRRC) introduced by ... 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