MDD指南,MEDDEV 2.12-1 rev.8-2013.01, 医疗器械警戒系统指南
Revision 8 of MEDDEV 2.12-1 explicitly includes IVF/ART devices within the scope of the vigilance system and provides clarity in relation to devices that are not intended to act directly on the individual. The revised guidance will be applicable as of July 2013.
3 SCOPE ............................................................................................................................................. 5 3.1 GENERAL PRINCIPLES ...................................................................................................... 6 3.1.1 FOR MANUFACTURERS .................................................................................................. 6 3.1.2 FOR MANUFACTURERS OF DEVICES THAT ARE NOT INTENDED TO ACT DIRECTLY ON THE INDIVIDUAL ...................................................................................... 7 3.1.3 FOR NATIONAL COMPETENT AUTHORITIES................................................................ 7 3.1.4 FOR USERS ....................................................................................................................... 8 4 DEFINITIONS ................................................................................................................................... 8 4.1 ABNORMAL USE ................................................................................................................. 8 4.2 AUTHORISED REPRESENTATIVE ..................................................................................... 8 4.3 CORRECTIVE ACTION ........................................................................................................ 9 4.4 DRUG / DEVICE COMBINATION PRODUCT ...................................................................... 9 4.5 EUDAMED............................................................................................................................. 9 4.6 FIELD SAFETY CORRECTIVE ACTION (FSCA) ................................................................ 9 4.7 FIELD SAFETY NOTICE (FSN) .......................................................................................... 10 4.8 HARM .................................................................................................................................. 11 4.9 IMMEDIATELY .................................................................................................................... 11 4.10 INCIDENT ............................................................................................................................ 11 4.11 INDIRECT HARM ................................................................................................................ 11 4.12 INTENDED PURPOSE........................................................................................................ 12 4.13 MANUFACTURER .............................................................................................................. 12 4.14 MEDICAL DEVICE .............................................................................................................. 12 4.15 OPERATOR ........................................................................................................................ 12 4.16 PERIODIC SUMMARY REPORTING ................................................................................. 12 4.17 SERIOUS PUBLIC HEALTH THREAT ............................................................................... 13 4.18 TREND REPORTING .......................................................................................................... 13 4.19 UNANTICIPATED ............................................................................................................... 13 4.20 USE ERROR ....................................................................................................................... 13 4.21 USER ................................................................................................................................... 13 5 MANUFACTURERS´ ROLE .......................................................................................................... 13 5.1 INCIDENT REPORTING SYSTEM ..................................................................................... 13 5.1.1 CRITERIA FOR INCIDENTs TO BE REPORTED BY MANUFACTURERS TO COMPETENT AUTHORITIES .......................................................................................... 14 5.1.2 CONDITIONS FOR PERIODIC SUMMARY REPORTING UNDER THE MEDICAL DEVICE VIGILANCE SYSTEM ........................................................................................ 16 5.1.2.1 INCIDENTS DESCRIBED IN A FIELD SAFETY NOTICE...................................... 16 5.1.2.2 COMMON AND WELL-DOCUMENTED INCIDENTS ............................................ 16 5.1.3 CONDITIONS WHERE REPORTING UNDER THE MEDICAL DEVICE VIGILANCE SYSTEM IS NOT USUALLY REQUIRED ........................................................................ 17 5.1.3.1 DEFICIENCY OF A DEVICE FOUND BY THE USER PRIOR TO ITS USE .......... 17 5.1.3.2 EVENT CAUSED BY PATIENT CONDITIONS ...................................................... 17 5.1.3.3 SERVICE LIFE OR SHELF-LIFE OF THE MEDICAL DEVICE EXCEEDED ......... 18 5.1.3.4 PROTECTION AGAINST A FAULT FUNCTIONED CORRECTLY ........................ 18 5.1.3.5 EXPECTED AND FORESEEABLE SIDE EFFECTS .............................................. 19 5.1.3.6 NEGLIGIBLE LIKELIHOOD OF OCCURRENCE OF DEATH OR SERIOUS DETERIORATION IN STATE OF HEALTH................................................................................ 20 5.1.4 TREND REPORTS ........................................................................................................... 20 5.1.5 REPORTING OF USE ERROR AND ABNORMAL USE .................................................. 21 5.1.5.1 REPORTABLE USE ERRORS ............................................................................... 21 5.1.5.2 USE ERROR WHERE REPORTING UNDER THE MEDICAL DEVICE VIGILANCE SYSTEM IS NOT USUALLY REQUIRED. ................................................................................. 21 5.1.5.3 CONSIDERATION FOR HANDLING ABNORMAL USE ........................................ 21 2
欧盟指令法规及程序
N/A
附录 III
EC 符合性声明（制造商自我 声明）
N/A
公告机构是否介入 YES YES YES YES YES
YES NO
器械风险递增
6
注册和授权代表
98/79/EC 规定欧洲数据库的其中一个职责 是主管当局之间共享关键数据，但目前该 项目仍在进行中。一旦该项目执行，则制 造商只需在其所在国或在其授权代表 (AR) 所在国注册即可。目前，临时取代措施是 要求制造商在初始注册后，通知其他成员 国的主管当局。制造商如果确定了潜在的 目标市场，则需研究该国的具体实施要 求，以确定是否需要通报相关部门。
• “体外诊断医疗器械可以是试剂、试剂 产品、校准物、控制物、试剂盒、器 具、仪器、设备或系统等任何形式的医 疗器械，无论是单独使用或组合使用， 由制造商预期用于体外检测取自人体的 样本，包括血液和其他组织，且其主要 目的是提供如下信息：生理或病理状 态、或有关于先天性异常、或确定潜在 接受者的安全性和兼容性、或监测治疗 措施。”
对于 LIST A 中风险程度最高的器械，需要 有额外的措施来把控风险。在附录 IV 全面 质量保证的符合性评价程序下，每个 LIST A 的器械必须经过详细的技术文件评审， 即 EC 设计审查。无论是参照哪项程序， 在获得 CE 标志后，任一批 LIST A 的产 品在交付市场前，还需进行持续的逐批验 证，以确保器械性能的持续稳定。
医疗器械警戒系统指南(MEDDEV第8版) 附录3和4_中英文
附件3 制造商向国家主管当局提交报告格式表ANNEX 3 REPORT FORM FOR MANUFACTURER’S TO THE NATIONAL COMPETENTAUTHORITYManufacturer’s Incident Report制造商事故报告医疗器械警戒系统本人保证就本人所掌握的知识范围,上述信息是正确的。
I affirm that the information given above is correct to the best of my knowledge.签名Signature姓名Name：城市City:日期Date:Submission of this report does not, in itself, represent a conclusion by the manufacturer and/or authorized representative or the National Competent Authority that the content of this report is complete or accurate, that the medical device(S) caused or contributed to the alleged death or deterioration the state of the health of any person.本报告的提交本身并不代表制造商和／或其授权代表或国家主管当局对本报告的内容完整或准确的结论，也不代表所列医疗器械的任何错误和／或医疗器械引起或促成了宣称的任何人的死亡或其健康六况的严重损坏。
附录4 欧洲市场安全纠正措施ANNEX 4 EUROPEAN FIELD SAFETY CORRECTIVE ACTION REPORT FORM医疗器械警戒系统(MEDDEV 2.12/1 rev 8)本人保证就本人所掌握的知识范围,上述信息是正确的。
MEDDEV2.12.2rev2...
MEDDEV2.12.2rev2...MEDDEV 2.12/2 rev2 January 2012GUIDELINES ON MEDICAL DEVICESPOST MARKET CLINICAL FOLLOW-UP STUDIESA GUIDE FOR MANUFACTURERS AND NOTIFIED BODIES 关于医疗设备指导方针药品上市后临床跟踪研究指导生产商和相关人员NoteThe present Guidelines are part of a set of Guidelines relating to questions of application of EC-Directives on medical Devices. They are legally not binding. The Guidelines have been carefully drafted through a process of intensive consultation of the various interest parties (competent authorities, Commission services, industries, other interested parties) during which intermediate drafts where circulated and comments were taken up in the document. Therefore, this document reflects positions taken by representatives of interest parties in the medical devices sector. 注释本准则是有关欧共体指令对医疗器械的应用问题指引的一部分。
其在法律上不具约束力。
医疗器械警戒系统指南-MEDDEV 2.12-1 REV.8 January 2013
MEDICAL DEVICES: Guidance document
MEDDEV 2.12-1 rev 8 January 2013
GUIDELINES ON A MEDICAL DEVICES VIGILANCE SYSTEM
The present guidelines are part of a set of guidelines relating to questions of application of EC-Directives on MEDICAL DEVICEs. They are legally not binding. The guidelines have been carefully drafted through a process of intensive consultation of the various interested parties (competent authorities, Commission services, industries, other interested parties) during which intermediate drafts were circulated and comments were taken up in the document. Therefore, this document reflects positions taken by representatives of interested parties in the MEDICAL DEVICEs sector.
3 SCOPE ...........................................................................................
MDD指南,MEDDEV 2.1.1 -1994.04, 医疗器械、附件、制造商的定义
EUROPEAN COMMISSIONDG ENTERPRISEDirectorate GUnit 4 - Pressure Equipment, Medical Devices, MetrologyMEDICAL DEVICES : Guidance documentMEDDEV 2. 1/1April 1994GUIDELINES RELATING TO THE APPLICATION OF :THE COUNCIL DIRECTIVE 90/385/EEC ON ACTIVE IMPLANTABLE MEDICAL DEVICESTHE COUNCIL DIRECTIVE 93/42/EEC ON MEDICAL DEVICESDefinition of "medical devices"Definition of "accessory"Definition of "manufacturer"--- (())---LIST OF CONTENTSI.FIELD OF APPLICATION - DEFINITIONS1.Directive 93/42/EE on medical devices2.Directive 90/385/EEC on active implantable medical devices13.Interface with other directives- medical devices/medicinal products- medical devices/electromagnetic compatibility2- medical devices/personal protective equipment2II.CLASSIFICATION OF MEDICAL DEVICES COVERED BY DIRECTIVE 93/42/EEC3III.CONFORMITY ASSESSMENT PROCEDURES(*):1.CE-marking2.Application-Annex 5-Annex 2. Quality systems. Examination of the design dossier- Annex 33.Conduct of audits44.Format of decisions, design examination certificate5.Technical DossierIV.CUSTOM MADE DEVICES(*):V.DEVICES INTENDED FOR CLINICAL INVESTIGATIONS(*):VI.MEDICAL DEVICE VIGILANCE(*):E OF LANGUAGES(*):VIII.TRANSITIONAL PERIOD(*):1see MEDDEV. 5/93 rev. 22see MEDDEV 13/933see MEDDEV.10/93 rev. 14see MEDDEV. 1/94I.FIELD OF APPLICATION - DEFINITIONS1.Directive 93/42/EEC on medical devices1.1Definition of "medical devices"a)devices - accessoryThe definition of the term "medical device" together with thedefinition of "accessory" is determinant for the delimitation of the fieldof application of Directive 93/42/EEC. A slight difference existsbetween the definition in article 1(2) (a) of Directive 93/42/EEC and inarticle 1(2) of Directive 90/385/EEC.Following the latter directive, accessories are by definition medicaldevices, whilst following Directive 93/42/EEC, a distinction is madebetween "devices" and "accessories". Therefore within the meaning ofDirective 93/42/EEC, accessories are products in their own right and,although being treated as devices (article 1(1)) do not follow, as ageneral rule, the classification of related devices in conjunction withwhich they are used.Accessories are therefore following Directive 93/42/EEC to beclassified in their own right.b)medical purposeMedical devices are defined as articles which are intended to be usedfor a medical purpose. The medical purpose is assigned to a productby the manufacturer. The manufacturer determines through the label,the instruction for use and the promotional material related to a givendevice its specific medical purpose. As the directive aims essentially atthe protection of patients and users, the medical purpose relates ingeneral to finished products regardless of whether they are intendedto be used alone or in combination. This means that the protectionensured by the directive becomes valid for products having a stage ofmanufacture, where they are supplied to the final user.Following this concept, raw materials, components or intermediateproducts are as such normally not medical devices. Such rawmaterials may need to present properties or characteristics which aredeterminant for the safety and quality of finished devices. It istherefore the responsibility of the manufacturer of finished devices toselect and control by adequate means his raw materials orintermediate products (see Annex I, section 7.1; Annex II, section 3.2;Annex V, section 3.2 of Directive 93/42/EEC)Spare parts supplied for replacement of existing components of adevice, the conformity of which has already been established, are notmedical devices. If spare parts, however, change significantly thecharacteristics or performances of a device with regard to its alreadyestablished conformity, such spare parts are to be considered asdevices in their own right.c)customizingThe concept of "finished device" does not imply that a device whenreaching the final user is already in a state ready for use. Prior to usefurther preparatory processing, preparation, configuration,installation, assembling, adaptation or fitting to the needs of the useror patient may be required. Examples :-sterilisation of medical devices supplied non-sterile-assembling of systems-configuration of electronic equipment-preparation of a dental filling-fitting of contact lenses-adaptation of prosthesis to the needs of the patient.The aforementioned activities are normally not manufacturersactivities if they are carried out by the final user as part of the use orpreparation for use. In this context a distinction needs to be madebetween a typical professional activity performed by a healthcareprofessional and processing and assembling activities done by aspecialist for such processing. In the latter case relevant activities maybecome proper manufacturing or assembling activities relevant withinthe meaning of articles 11 and 12.A particular consideration in this context needs to be given for themanufacture of custom-made devices. Custom-made devices (such as dental appliances, prosthesis, hearing-aid inserts) are in most casesone-off devices and the Directive subjects their manufacture to theprocedure of article 11(6) in conjunction with Annex VIII. In thesecases intermediate products specifically intended for this kind ofcustom-made devices may be considered also as medical devices.This applies essentially to dental alloys, dental ceramics, modularcomponents for prosthesis, if the intended purpose of such products is specifically related to medical devices.d)medical - toiletry purposeThe definition of "medical device" should be understood to includeproducts intended to be used principally for a medical use. Thereforeproducts intended to have a toiletry or cosmetic purpose are notmedical devices even though they may be used for prevention of adisease. Examples for products for which a medical purpose cannormally not be established :-tooth brushes, dental sticks, dental floss;-baby diapers, hygiene tampons;-contact lenses without corrective function intended toprovide another colour to the eyes,-bleaching products for teeth [needs to be furtherdiscussed with regard to products intendedspecifically for application by dentists]-instruments for tattooing.Examples for products, where depending on the circumstances, amedical purpose can be established :-incontinence products.e)aids for handicapped personsIn the case of equipment intended for alleviation of or compensationfor a handicap, there must be a direct link between the correctivefunction and the person concerned. Therefore the followingequipment are not medical devices :-acoustic signals at traffic lights,-special water taps, toilet equipment for handicappedf)softwareThe following distinction can be made : software influencing theproper functioning of a device and software used in combination withnon-medical equipment.Software related to the functioning of a medical device may be part ofa device or a device in its own right if it is placed on the marketseparately from the related device.In the case of software intended for use with multipurpose informaticequipment a distinction has to be made between software providingfor a proper diagnostic or therapeutic tool and software for handlinggeneral patient-related data. Only in the first case may a medicalpurpose be determined. Examples for medical devices :-calculation of anatomical sites of the body,-image enhancing software intended for diagnosticpurpose.-software for programming a medical deviceThere is no medical purpose in the case of software used foradministration of general patient datag)multipurpose productsProducts with a multiple purpose which may be used occasionally in amedical environment are normally not medical devices, unless aspecific medical intended purpose is assigned to them. Examples :-multipurpose PC, printer, scanner, ..._magnetoscope, screen.1.2Definition of "accessory"The question whether a product is a "device" or a "accessory" has notpractical consequence. Following article 1(1) of Directive 93/42/EEC,"accessories shall be treated as medical devices in their own right". Therefore the main question is whether a product with a rather remote link to amedical use can still be considered as "accessory" (article 1(2)b) and as amatter of consequence is covered by the directive.The definition of "accessory" requires that the accessory is specificallyintended by the manufacturer of the accessory to be used together with adevice. The intended use of the accessory must be such as to enable a device to be used in accordance with its intended use. Therefore a product can only become an accessory to a medical device if the manufacturer of such aproduct establishes an intended use in conjunction with one or severalmedical devices.Examples for accessories depending on defined circumstances of device-related use :-sterilizers for use in a medical environment,-pouches for packaging re-sterilised medical devices,-specific battery chargers for battery driven electromedicaldevices,-contact lens care products, disinfectants specificallyintended for invasive medical devices-special water treatment device for use in conjunction withdialyzing machines,-gas cylinders/pressure release devices for use inconjunction with anaesthesia machines.1.3Definition of "manufacturer"Users in-house manufacturingThe Directive defines a manufacturer as the natural or legal personresponsible for defined manufacturing activities related to a device with aview to its being placed on the market under the manufacturers own name.The reason for this link with the placing on the market is that the directives aims to subject to its protection requirements the transaction of a device from the sphere of a manufacturer towards the public. The directive does notprovide any specific provisions for the case where a device is manufactured by the user (for example, a hospital) without being transferred to anotherperson. The decision to which extent such in-house manufacturing activities by hospitals are subjected to legal requirements, belongs therefore to thenational legislator. This relates however exclusively to such in-housemanufacturing activities where a device remains within the users, but not to cases where, for example, a hospital produces orthopaedic devices for usewith patients.。
MEDDEV2.122上市后临床跟踪指南中英文对照版
EUROPEAN COMMISSIONDG ENTERPRISEDirectorate GGUIDELINES ON POST MARKET CLINICAL FOLLOW-UP上市后临床跟踪指南The present Guidelines are part of a set of Guidelines relating to questions of application of EC-Directives on medical devices. They are legally not binding. The Guidelines have been carefully drafted through a process of intensive consultation of the various interested parties (competent authorities, Commission services, industries, other interested parties) during which intermediate drafts were circulated and comments were taken up in the document. Therefore, this document reflects positions taken by representatives of interested parties in the medical devices sector.本准则是一个有关的欧共体指令对医疗设备的应用问题指引的一部分。
他们在法律上没有约束力。
该指引已审慎草拟通过各有关方面（主管机关，委员会的服务，工业，其他有关各方）在此期间，中间草案分发和评论的文件采取了密集的磋商进程。
因此，这份文件反映了有关各方的代表在该领域采取的医疗设备的位置。
欧盟医疗器械MDR与MDD分类详细比较表
欧盟医疗器械MDR与MDD分类详细比较表
此外以下无医学用途的物品也归类为医疗器械:
1.蒯用于放入眼睛内或放到眼睛上的隐形眼镜或其他物品；
2.为修改解剖学或固定身体部位通过手术创伤的方式整体或部分放入人体内的产品，但纹身产品和穿孔产品除外;
3.预期通过皮下、粘膜下或皮内注射的方式或其他进入方式用于面部或其他皮肤或粘填充的物质、物质组合或物品，但不包括
纹身所用的物质；
4.预期用于减少、去除或破坏脂肪组织的器械，如吸脂术、月鼬分解蜘脂所用的器械；
5.发射高强度电磁辐射（例如，红外线、可见光和紫外线）用于在人体上进行磨皮、纹身或脱毛或其他皮肤治疗的器械，包括
相干和三厢干光源、单色光谱和广谱,如激光和强瞅中光器械；
6.预期使用电流或磁场或电磁场穿透颅骨来修改大脑中的神经元活动，以^凰脑部的器机。
欧盟医疗器械警戒系统指南
欧盟医疗器械警戒系统指南——杨悦汤涵令狐昌黎刘东旭译从2008年1月1日起，欧盟开始实施新的《医疗器械警戒系统指南》（MEDDEV2.12/1-第五版，2007年4月发布，以下简称《指南》）。
该《指南》是在2001年4月发布的《欧盟医疗器械指令》（MEDDEV2.12/1-第四版，以下简称《指令》）基础上修订的，修订内容包括：1.将医疗器械全球协调行动任务组（GHTF）国际法规中关于医疗器械警戒及售后监督的指南性文件予以考虑，并将其相关内容转换成适用于欧盟的条款；2.介绍了欧盟医疗器械数据库（EUDAMED）；3.根据2001年《指令》实施的经验修改了一些规范性文件。
一、《指南》简介《指南》的主要内容有欧盟体系中医疗器械事件报告、评价及现场安全纠正措施（Field Safety Corrective Actions，以下简称FSCA），即医疗器械警戒系统的全部内容。
建立医疗器械警戒系统的主要目的是通过降低事件复发率的可能性来提高对患者、器械使用者及其他人的健康和安全的保护。
要达到这一目标，需有关部门通过对上报的不良事件进行评价，并利用适当的信息发布防止此类事件的重复发生或者减轻事件后果。
该《指南》旨在促进以下指令对医疗器械警戒系统所要求内容的统一应用和实施：1.有源植入式医疗器械指令（the Directive for Active Implantable Medical Devices，简称AIMD），90/385/EEC；2.医疗器械指令（the Directive for Medical Devices，简称MDD），93/42/EEC；3.体外诊断医疗器械指令（the In Vitro Diagnostic Medical Devices Directive，简称IVDD），98/79/EC。
现场安全纠正措施（FSCA）、现场安全通报（FSN）、错误使用和非正常使用均为该《指南》新加入的内容，目的是为了在促进医疗器械全球协调行动工作组（GHTF）制定的法规与欧盟环境相协调过程中，强化和明确欧盟医疗器械警戒系统。
MDR医疗器械法规考核试题及答案
MDR医疗器械法规考核试题一、选择题1.下列产品中,属于MDR指令适用范围的是（）［多选题］。
A、新冠抗原检测试剂B、连接呼吸机使用的面罩，C、用于化妆的美瞳√D、用于实时监测呼吸的软件V2.在MDR/IVDR规定中，以下附录规定了CE技术文件的具体内容（）［多选题］。
A、附录IB、附录DVC、附录ΠI√D、附录IV3.针对（）医疗器械,制造商需要编写PSUR（PeriodiCSafetyUPdaterePc）rt）并提交给公告机构评审。
［多选题］*A、I类医疗器械B、Hb类医疗器械√C、IIa类医疗器械√D、所有医疗器械4.针对（）医疗器械，在需要在发证前完成"C1inica1eva1uationConSUItationProCedUre"。
［多选题］*A、In类植入性医疗器械√B、∏a类医疗器械C、∏b类控制药物使用医疗器械√D、所有医疗器械5.11a类和IIb类医疗器械需要在（）之前，带有UDI编码才可销售［单选题］。
A、2019-05-26B、2023-05-26C、2023-05-26√D、2025-05-266.医疗器械进行符合性声明（Dec1arationofconformity）包含的内容（）侈选题］。
A、附录I+附录UB、附录IVVC、附录IXChaPter1D、产品的分类和分类规则V7.11a类医疗器械的定期安全更新报告PeriOdiCSafetyUPdaterePort（PSUR）需要最少每（泽更新一次，并提供给公告机构审查。
［单选题］*A、一B、二√C、ΞD、四8.对于医疗器械的CE技术文件保存的要求有？（）A、要保存在欧盟境内√B、仅由制造商保存即可C、在最后一个器械投放市场后，至少10年，可植入器械至少15年√D、在最后一个器械投放市场后，至少5年9.欧盟的Eudamed数据库将会包含以下信息（）［多选题］。
A、UDI-D1数据库B、SRN数据库√C、公告机构资质及CE证书查询数据库√D、临床研究数据库√E、警戒系统及市场抽查数据库V1（λ根据描述，请选择正确的经济运营商类型，把欧洲境外的产品投放欧洲市场的人（）［单选题］。
警戒系统培训
10 附件
• 附件 1制造商需要报告的事故实例 • 附件 3 制造商向国家主管当局提交报告格 式表 • 附录 4 欧洲市场安全纠正措施 • 附件 5 市场安全通知模板 • 附录 6 制造商定期总结报告 • 附录 7 制造商趋势报告
• 附件 11 当警戒系统涉及到使用者时的制造 商指南
•涉及表格
• 4 定义 • Rev 8 and Rev 7对比的变化有
4.6 FIELD SAFETY CORRECTIVE ACTION (FSCA) 4.11 INDIRECT HARM Some diagnostic devices and all IVDs 4.6 FIELD SAFETY CORRECTIVE ACTION (FSCA) 4.11 INDIRECT HARM diagnostic devices IVDs and IVF/ART medical devices Revise the Note 2 and add the content of Note 3 -Note 5. Add the content of IVF/ART medical devices and the content of indirect harm.
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严重损害健康的情形可能包括: A) 危及生命的疾病； B) 身体机能的永久损失或身体结构的永久损坏； C) 必须以医疗或手术的方式以避免上述 a)b)的发生。 如：—外科手术过程中中临床方面的增加； —需住院或明显延长了住院时间的情况。 D） 任何非直接的损伤 （见 4.11 的定义), 作为依据制造商的使用说明得到一 个不正确的 IND 试验结果所引起的后果。 E) 胎儿缺陷，胎儿死亡异味任何不正常的妊娠或生育缺陷。 注： 并非所有的事故都导致死亡必健康的严重损害。 未发生的情形可能归功 于侥幸的环境因 素和医护人员的介入。 下面这两条已足够构成需要报告的事故： l 一个与器械相关联的事故发生了，和 l 事故如果再次发生，可能引起了死亡或健康状况的严重损坏。 需报告的例子见附件 1.