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所在平台: Udemy |
课程主页: https://www.udemy.com/course/ivdr-2017-746-regulatory-affairs/
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**课程名称：** IVDR 2017/746 法规事务：学习欧盟合规 **课程概述：** 本课程共九个部分，旨在用简单易懂的语言解释《体外诊断医疗器械法规 2017/746》（IVDR 2017/746）。 * **第一部分：引言** * 介绍 IVDR 2017/746。 * 解释从指令到 IVDR 2017/746 的变化原因。 * 讨论 IVDR 2017/746 的过渡时间表。 * **第二部分：经济运营者** * 定义经济运营者及其类型（制造商、进口商、分销商、欧盟授权代表）。 * 阐述各类经济运营者的义务，以及义务何时发生变化。 * 解释负责法规合规人员的义务。 * **第三部分：EUDAMED** * 介绍 EUDAMED 及其作用。 * 理解“参与者注册”的含义。 * 讨论 EUDAMED 系统的过渡时间表。 * **第四部分：唯一器械标识 (UDI) 和注册** * 介绍 UDI 及其必要性。 * 理解 UDI 载体。 * 了解可创建 UDI 载体标准的授权组织。 * 说明 UDI 载体需要附加在包装和器械上的时间表。 * **第五部分：体外诊断医疗器械分类** * 解释体外诊断医疗器械的资质认定。 * 介绍 IVDR 2017/746 的分类规则，并提供实践案例。 * 帮助学员理解如何进行器械分类。 * **第六部分：合格评定** * 阐述 A、B、C、D 四类体外诊断医疗器械的合格评定途径。 * **第七部分：充分的临床数据** * 讲解通用安全和性能要求。 * 解释预期用途。 * 说明充分的临床数据、临床评估和上市后性能随访 (PMPF) 的重要性。 * **第八部分：上市监督** * 介绍上市监督 (PMS) 原则。 * 讲解上市后监督报告和定期安全性更新报告。 * 阐述上市监管和监管数据的分析。 * 说明主管当局和欧盟委员会在市场监督中的作用。 * **第九部分：其他事项** * 讨论医疗器械协调小组。 * 分析英国脱欧、瑞士互认协议、土耳其和欧洲自由贸易协会 (EFTA) 与欧盟的协议。 * 介绍通用规范和滚动计划。 * 说明欧盟参考实验室如何支持 IVDR 的实施。 **课程收益：** * 节省时间，以最简单的方式深入理解法规。 * 帮助学员根据 IVDR 2017/746 时间表确定工作优先级。 * 了解法规出台的原因以及自身在 IVDR 2017/746 和 EUDAMED 中的义务和时间表。 * 通过实例了解 UDI 载体的创建和器械分类。 * 明确各类体外诊断医疗器械应遵循的合格评定路径。 * 了解合规所需的充分临床数据以及上市监督要求。 * 理解英国脱欧后，英国和欧盟制造商的责任。 * 了解土耳其和 EFTA （瑞士、列支敦士登、挪威和冰岛）制造商在 IVDR 2017/746 下的责任。 * 理解欧盟参考实验室在 IVDR 实施过程中的支持作用。
This Course is broken into nine sections. The objective of the course is to explain the in vitro diagnostic medical device regulation 2017/746 in simple terms:Section 1 Introduction.Introduction to the in vitro diagnostic medical device regulation 2017 746.Why was there a change from the directive to the IVDR 2017 746?The timelines for the transition of the IVDR 2017 746.Section 2 Economic Operator.Economic Operators. Who are they?Economic Operator. The European Authorised representative. Explain their obligation.Economic Operator. The Distributor. Explain their obligation.Economic Operator. The Importer. Explain their obligation.Economic Operator. The Manufacturer. Explain their obligation.When does an Economic operator obligation change?Explain the obligation of a person responsible for regulatory complianceSection 3 EUDAMEDIntroduction to what EUDAMED is.Understand what is meant by the actor registration.The timelines for the transition of EUDAMED systemSection 4 Unique Device Identification and registrationUDI Introduction. What is it? Why is it needed?UDI The Carrier. Understand the unique device identification carrier.UDI Accredited Organisation. Understand who the current accredited organisations are that can create Unique Device identification carrier standards.UDI timelines. When the UDI carrier needs to be attached to the packaging and devices.Section 5 Classification of in vitro diagnostic medical devicesQualification of in vitro diagnostic medical devices. Determine if the manufacturer is making a medical device.Classification of in vitro diagnostic medical devices Introduction.Understand in vitro diagnostic medical device definitions. This will help the student how to classify a medical device.Rules of in vitro diagnostic medical device classification. Understand the implementation of the rules.IVDR apply in vitro diagnostic medical device rules.Section 6 Conformity assessmentExplain the Conformity assessment path for Class A in vitro diagnostic medical devices. Explain the Conformity assessment path for Class B in vitro diagnostic medical devices. Explain the Conformity assessment path for Class C in vitro diagnostic medical devices. Explain the Conformity assessment path for Class D in vitro diagnostic medical devices.Section 7 Sufficient Clinical dataThe General Safety and Performance Requirements.The Intended purpose.Sufficient clinical Data. Clinical Evaluation.Post Market Performance Follow up (PMPF).Section 8 Post Market Surveillance.Post Market Surveillance.Post-market surveillance report & Periodic safety update.Post-market vigilance.Analysis of vigilance data.Role of Competent Authority & European Commission within Market SurveillanceSection 9 Other ItemsMedical device coordination groupBrexitSwitzerland Mutual Recognition AgreementTurkey and EFTA agreement with the EU.Common SpecificationsThe Rolling plan.European Union Reference LaboratoriesThe benefits of the course will be:Save you time.Really understand regulation in simple terms.Help you prioritizes work to prepare for the IVDR 2017 746 timelines.Understand why regulation was introduced.Know your obligation to the IVDR 2017 746.Know the obligation to EUDAMED and the timelines.Examples of how Unique Device Identification carriers are created.Worked examples how in vitro diagnostic medical devices are classified.Know the conformity assessment route to take for each in vitro diagnostic medical device.Know what sufficient clinical data to collect to be compliant.Understand the market surveillance requirements to allow the in vitro diagnostic medical device to stay in the marketplace.Understand the UK and EU manufacturers responsibility post Brexit.Understand Turkey and the EFTA (Switzerland, Liechtenstein, Norway, and Iceland) manufacturers responsibility regarding the IVDR 2017 746.Understand how the European Union Reference laboratories support the implementation of the IVDR.
