- Commission Implementing Regulation 920/2013 of 24 September 2013 on the designation and the supervision of notified bodies under Council Directive 90/385/EEC on active implantable medical devices and Council Directive 93/42/EEC on medical devices
Harmonised and International standards: 协调标准和国际标准
- EN ISO 14155:2011 Clinical investigation of medical devices for human subjects – Good clinical practice EN ISO 14155:2011 人体用医疗器械的临床调查—优良的临床规范
- EN ISO 14971:2012 Medical devices – application of risk management to medical devices EN ISO 14971:2012 医疗器械 – 风险管理对医疗器械的应用 European guidance documents: 欧盟指南文件
- MEDDEV 2.12/1 Guidelines on a medical devices vigilance system MEDDEV 2.12/1 医疗器械警戒系统指南
- MEDDEV 2.12/2 Guidelines on post market clinical follow-up studies: a guide for manufacturer and notified body
MEDDEV 2.12/2 上市后的临床跟踪指南
- MEDDEV 2.4/1 Classification of medical devices MEDDEV 2.4/1 医疗器械的分类
- MEDDEV 2.7/2 Guidelines for competent authorities for making a validation/assessment of a clinical investigation application under directives 90/385/EEC and 93/42/EC MEDDEV 2.7/2 主管部门进行临床研究应用的验证/评估指南
- Manual on borderline and classification in the Community regulatory framework for medical devices 人工边界和分类，医疗器械在社区的监管架构 - NBOG BPG 2006-1 Change of notified body NBOG BPG 2006-1 公告机构的变更
- NBOG BPG 2009-1 Guidance on design-dossier examination and report content NBOG BPG 2009-1 设计档案检查和报告内容的指南
- NBOG BPG 2009-4 Guidance on notified body?s tasks of technical documentation assessment on a representative basis
NBOG BPG 2009-4 公告机构技术文件评估指南
- NBOG BPG 2010-2 Guidance on audit report content NBOG BPG 2010-2 审计报告内容指南
- NBOG BPG 2014-1 Renewal of EC design-examination and type-examination certificates: Conformity assessment procedures and general rules
NBOG BPG 2014-1 EC设计审核和型式检验认证：符合性评估程序和一般规则
- NBOG BPG 2014-2 Guidance on the information required for notified body medical device personnel involved in conformity assessment activities
NBOG BPG 2014-2 公告机构医疗设备人员参与合格评定活动所需信息的指南
- NBOG BPG 2014-3 Guidance for manufacturers and notified bodies on reporting of design changes and changes of the quality system
NBOG BPG 2014-3 制造商和公告机构报告设计变更和质量体系变更的指南 Other guidance documents:其他指南文件
- GHTF SG5 N1R7:2007: Clinical evidence - Key definitions and concepts GHTF SG5 N1R7:2007 临床证据—关键定义和概念 - GHTF SG5 N2R8:2007: Clinical evaluation 临床评价
- GHTF SG5 N41R9:2005: Essential principles of safety and performance GHTF SG5 N41R9:2005: 安全和有效的基本原则
This list contains documents available at the time this MEDDEV document was published. In general, the most recent versions of standards and legal texts should be used.
这个列表包含文件时可用MEDDEV文档发表。一般来说，应当使用最新版本的标准和法律文本。 4. Definitions 定义
4.1 Adverse event: any untoward medical occurrence, unintended disease or injury, or any untoward clinical signs (including an abnormal laboratory finding) in subjects, users or other persons whether or not related to the investigational medical device.
不良事件：任何不幸的医疗事件，非预期的疾病或伤害，或任何不幸的临床症状（包括反常的试验检查）在受试者、使用者、或无论是否与临床实验的医疗设备相关的其他人员。
NOTE 1: This includes events related to the investigational device or the comparator. 包括 相关的调查设备和对照设备
NOTE 2: This includes events related to the procedures involved.
NOTE 3: For users or other persons this is restricted to events related to the investigational medical device.对使用者或其他人员仅限于调查器械相关的事件。 [EN ISO 14155:2011]
4.2 Bias: bias is a systematic deviation of an outcome measure from its true value, leading to either an
overestimation or underestimation of a treatment‘s effect. It can originate from, for example, the way patients are allocated to treatment, the way treatment outcomes are measured and interpreted, and the way data are recorded and reported. [Adapted from GHTF SG5/N2R8:2007]
偏见：偏见是一个从它的真正价值和测量结果之间的系统性偏差，导致一个高估或者低估治疗的效果。可能来源于，例如病人分配给治疗的方式，治疗结果的测量和解释方式，数据记录和报告的方式。
4.3 Clinical data: the safety and/or performance information that is generated from the clinical use of a device. Clinical data are sourced from:
由医疗器械的临床使用生成的安全和/或性能信息，临床数据包括：
- clinical investigation(s) of the device concerned; or设备有关的临床调查，或
- clinical investigation(s) or other studies reported in the scientific literature, of a similar device for which
equivalence to the device in question can be demonstrated; or临床调查或科学文献的研究报告，或者类似设备的等价性问题可以被证明，或
- published and/or unpublished reports on other clinical experience of either the device in question or a similar device for which equivalence to the device in question can be demonstrated.公开发表或未公开发表的相同设备或者等价性问题可以被证明相似设备的临床经验报告 [derived from Article 1.2.k MDD and Art. 1.2.k AIMDD]
4.4 Clinical evaluation: a methodologically sound ongoing procedure to collect, appraise and analyse clinical data pertaining to a medical device and to evaluate whether there is sufficient clinical evidence to confirm compliance with relevant essential requirements for safety and performance when using the device according to the manufacturer‘s Instructions for Use.
临床评价：不间断收集、评价和分析适合于医疗器械的临床数据，评价是否足够充分的临床
证据来确认在根据制造商的使用说明书使用设备时，符合相关安全和性能相关的基本要求。
Note: In exceptional cases where an instruction for use is not required, the collection, analysis and assessment are conducted taking into account generally recognised modalities of use. 在一个不需要使用说明书的特殊情况下，收集、分析和评估考虑采用普遍认可的使用形式。
4.5 Clinical evidence: the clinical data and the clinical evaluation report pertaining to a medical device. [GHTF SG5/N2R8:2007]
临床证据: 适合于医疗器械的临床数据和临床评价报告
4.6 Clinical investigation: systematic investigation in one or more human subjects, undertaken to assess the safety or performance of a medical device.
临床调查： 在一个或多个人体受试者上进行的任何系统调查, 用于评估医疗器械的安全和/或性能。
Note: 'clinical trial' or ' clinical study' are synonymous with ' clinical investigation'. [EN ISO 14155:2011] clinical trial 等同于 clinical study
4.7 Clinical investigation plan: document that states the rationale, objectives, design and proposed analysis, methodology, monitoring, conduct and record-keeping of the clinical investigation. [EN ISO 14155:2011] 临床调查方案： 陈述基本原理，目标，设计和建议的分析、方法论、监测、进行和记录临床调查的文件
4.8 Clinical performance: behaviour of a medical device or response of the subject(s) to that medical device in relation to its intended use, when correctly applied to appropriate subject(s). [EN ISO 14155:2011] 临床性能: 医疗器械正确应用于合适的受试者，医疗器械的行为或者响应达到预期用途
4.9 Device registry: an organised system that uses observational study methods to collect defined clinical data under normal conditions of use relating to one or more devices to evaluate specified outcomes for a population defined by a particular disease, condition, or exposure and that serves predetermined scientific, clinical or policy purpose(s).
器械登记：一个组织系统，采用观察性研究方法来收集定义的临床数据，在正常使用情况下有关指定一个或多个设备评估结果，为一个特定的疾病、条件定义的人口或暴露和预定服务科学、临床或政策目的(s)。
Note: The term ―device registry‖ should not be confused with the concept of device registration and listing.
[MEDDEV 2.12/2 rev2]
4.10 Clinical safety: freedom from unacceptable clinical risks, when using the device according to the manufacturer‘s Instructions for Use. [MEDDEV 2.7/2 revision 2]
Note: In exceptional cases where an instruction for use is not required, the collection, analysis and assessment are conducted taking into account generally recognised modalities of use. 临床安全: 当根据说明书使用器械时，没有不可接受的临床风险。
4.11 Clinical use: use of a medical device in or on living human subjects.
Note: Includes use of a medical device that does not have direct patient contact. 临床使用： 医疗器械在人类活体上使用
4.12 Equivalent device: a device for which equivalence to the device in question can be demonstrated. [Derived from Art. 1.2.k MDD]
等价器械：一个器械的等同性问题能被证明的器械。
4.13 Feasibility study: a clinical investigation that is commonly used to capture preliminary information on a medical device (at an early stage of product design) to adequately plan further steps of device development, including needs for design modifications or parameters for a pivotal study. [MEDDEV 2.7/2 revision 2]
可行性研究：临床调查通常用于获取医疗设备初步信息 (在产品设计的早期阶段)而充分计划设备开发的未来步骤，包括需要设计修改或一个关键参数研究。
4.14 Harmonised standards: standards whose references have been published in the Official Journal of the European Communities. [Derived from article 5 of Directive 90/385/EEC and article 5 of Directive 93/42/EEC] 协调标准：已经发表在欧洲共同体的官方杂志上的应用标准。 4.15 Hazard: potential source of harm. [EN ISO 14971:2012] 危险：潜在的伤害。
4.16 Hazard due to substances and technologies: for the purpose of this MEDDEV document, a hazard that is seen with products that share specific characteristics.
危险物质和技术：为了MEDDEV文档的目的，看作分担特定特征的产品的风险。？
Note: This includes products that contain the same materials and substances, material combinations, use the same technologies, produce similar abrasion, are used with the same