Essential Requirements Checklist of the MDD07 47 EC基本要求检查表中英文.docx

1、Essential Requirements Checklist of the MDD07 47 EC基本要求检查表中英文 Essential Requirements of the MDD (07/47/EC) 医疗器械指令（07/47/EC）基本要求Applicable(Y/N)适用（是/否）Requirements Standard 所符合的标准要求ManufacturersCompliance/Records 制造商符合性文件/记录Ok / Fail符合/不符合 I.GENERAL REQUIREMENTS基本要求1.The devices must be designed and m

2、anufactured in such a way that, when used under the conditions and for the purposes intended, they will not compromise the clinical condition or the safety of patients, or the safety and health of users or, where applicable, other persons, provided that any risks which may be associated with their u

3、se constitute acceptable risks when weighed against the benefits to the patient and are compatible with a high level of protection of health and safety.This shall include: reducing, as far as possible, the risk of use error due to the ergonomic features of the device and the environment in which the

4、 device is intended to be used (design for patient safety), and consideration of the technical knowledge, experience, education and training and where applicable the medical and physical conditions of intended users (design for lay, professional, disabled or other users).必须确保医疗器械的设计和制造在使用时或将被使用时不危害临

5、床状况或不伤害到患者的健康，或使用者或其他人员的健康和安全，在产品使用过程中产生的与患者利益相关的风险应是可接受的且符合高级别的健康安全防护措施。应包括以下内容：尽可能地降低由于医疗器械的性能特征及其使用时所处的环境（为患者安全所设计）而导致的使用错误风险。考虑技术知识、经验、教育及培训程度、使用者的医疗条件和物理条件（为非专业人士、专业人士、残疾人士及其它使用者所设计）。2.The solutions adopted by the manufacturer for the design and construction of the devices must conform to safet

6、y principles, taking account of the generally acknowledged state of the art.In selecting the most appropriate solutions, the manufacturer must apply the following principles in the following order:制造商所采用的医疗器械的设计方法和结构方法必须符合安全准则，符合大众公认的技术声明文件。制造商必须依次采用以下准则以选择最适合的方法：eliminate or reduce risks as far as

7、possible (inherently safe design and construction),尽可能地消除或降低风险（固有安全设计和结构）where appropriate take adequate protection measures including alarms if necessary, in relation to risks that cannot be eliminated,有关风险不能被消除时，应采取适当的防护措施，必要时包括安装警报装置。inform users of the residual risks due to any shortcomings of t

8、he protection measures adopted.把采取了安全措施后仍然可能存在的风险告知给使用者。3.The devices must achieve the performances intended by the manufacturer and be designed, manufactured and packaged in such a way that they are suitable for one or more of the functions referred to in Article 1 (2) (a), as specified by the manu

9、facturer.制造商所设计的医疗器械必须达到预期的性能，并且其设计、生产和包装必须符合条款1（2）（a），由制造商规定的至少一项功能。4.The characteristics and performances referred to in sections 1, 2 and 3 must not be adversely affected to such a degree that the clinical condition and safety of the patients and, where applicable, of other persons are compromise

10、d during the lifetime of the device as indicated by the manufacturer, when the device is subjected to the stresses which can occur during normal conditions of use.涉及条款1,2和3的产品的特征和性能在制造商所指明的产品有效期内、在正常使用条件下受到挤压时必须不影响临床状况、患者安全以及其他人员的安全。5.The devices must be designed, manufactured and packed in such a w

11、ay that their characteristics and performances during their intended use will not be adversely affected during transport and storage taking account of the instructions and information provided by the manufacturer医疗器械的设计、制造和包装在其预期使用过程中其特性和性能不应受到损害，在按制造商提供的说明书和资料进行运输和储存时要保证其特性和性能的完整性。6.Any undesirable

12、 side effects must constitute an acceptable risk when weighed against the performances intended.6a. Demonstration of conformity with the essential requirements must include a clinical evaluation in accordance with Annex X.当医疗器械的预期性能受到影响时，任何不良副作用必须是可接受的风险。6a.依据附录X，符合性声明和基本要求中必须含有临床评估。II.REQUIREMENTS

13、REGARDING DESIGN AND CONSTRUCTION 设计和结构要求7. Chemical, physical and biological properties 化学性能、物理性能和生物性能7.1The devices must be designed and manufactured in such a way as to guarantee the characteristics and performances referred to in Section 1 on the General requirements. Particular attention must b

14、e paid to:医疗器械的设计和制造必须确保其符合“一般要求”中条款1所描述的特征和性能。应特别注意：the choice of materials used, particularly as regards toxicity and, where appropriate flammability,所用物料的选择，尤其要注意其毒性，必要时还要考虑其可燃性。the compatibility between the materials used and biological tissues, cells and body fluids, taking account of the inten

15、ded purpose of the device.where appropriate, the results of biophysical or modelling research whose validity has been demonstrated beforehand.根据医疗器械的预期用途，确保其所使用的物料与生物组织、细胞和体液之间的兼容性。必要时，生物或模化研究结果的有效性事先应得到验证。7.2The devices must be designed, manufactured and packed in such a way as to minimise the risk

16、 posed by contaminants and residues to the persons involved in the transport, storage and use of the devices and to the patients, taking account of the intended purpose of the product. Particular attention must be paid to the tissues exposed and the duration and frequency of the exposure.考虑到医疗器械的预期用

17、途，医疗器械的设计、制造和包装必须使污染物和残余物质对在运输、存储和使用过程中所涉及到的人员和患者所造成的风险降低到最低。尤其要注意暴露组织、持续时间和暴露频率。7.3The devices must be designed and manufactured in such a way that they can be used safely with the materials, substances and gases with which they enter into contact during their normal use or during routine procedure

18、s; if the devices are intended to administer medicinal products they must be designed and manufactured in such a way as to be compatible with the medicinal products concerned according to the provisions and restrictions governing those products and that their performance is maintained in accordance

19、with the intended use.医疗器械的设计和制造必须确保其所使用的物料、物质和气体在正常使用或惯常使用情况下能安全使用。如果医疗器械用于施用医疗产品，其设计和制造必须符合医疗的相关条款和制度，并按照预期用途保持其性能。7.4Where a device incorporates, as an integral part, a substance which, if used separately, may be considered to be a medicinal product as defined in Article 1 of Directive 2001/83/EC

20、 and which is liable to act upon the body with action ancillary to that of the device, the quality, safety and usefulness of the substance must be verified by analogy with the methods specified in Annex I to Directive 2001/83/ EC.当医疗器械组合成一个整体部件，其组合所使用的物质在单独使用时按照2001/83EC指令中章节1的规定可视作医疗产品，当作用于人体时，该物质在

21、医疗器械组合部件中起辅助作用，必须根据2001/83/EC指令附录 1中规定的方法类似的方法对物质的质量、安全和效用进行验证。 For the substances referred to in the first paragraph, the notified body shall, having verified the usefulness of the substance as part of the medical device and taking account of the intended purpose of the device, seek a scientific op

22、inion from one of the competent authorities designated by the Member States or the European Medicines Agency (EMEA) acting particularly through its committee in accordance with Regulation (EC) No 726/2004 (1) on the quality and safety of the substance including the clinical benefit/risk profile of t

23、he incorporation of the substance into the device. 关于第一段中所提到的物质，根据第726/2004号规则（1）中的规定，报告主体应对视作医疗产品组成部分的物质的效用进行验证并考虑到医疗器械的预期用途，关于物质的质量和安全，包括物质组合成医疗器械后产生的临床效益和风险，应通过其委员会寻求来自成员国或欧洲医疗代理机构指定的权威机构的科学观点。When issuing its opinion, the competent authority or the EMEA shall take into account the manufacturing

24、process and the data related to the usefulness of incorporation of the substance into the device as determined by the notified body. 当提出观点时，权威机构或欧洲医疗代理机构应把报告主体所规定的制造过程和物质组合成医疗器械后的相关效用数据考虑在内。Where a device incorporates, as an integral part, a human blood derivative, the notified body shall, having ve

25、rified the usefulness of the substance as part of the medical device and taking into account the intended purpose of the device, seek a scientific opinion from the EMEA, acting particularly through its committee, on the quality and safety of the substance including the clinical benefit/risk profile

26、of the incorporation of the human blood derivative into the device. 当医疗器械组合成一个整体部件，一个人体血液衍生物，报告主体应对视作医疗产品组成部分的物质的效用进行验证并考虑到医疗器械的预期用途，关于物质的质量和安全，包括物质组合成医疗器械后产生的临床效益和风险，应通过其委员会寻求来自成员国或欧洲医疗代理机构指定的权威机构的科学观点。When issuing its opinion, the EMEA shall take into account the manufacturing process and the data

27、 related to the usefulness of incorporation of the substance into the device as determined by the notified body.当提出观点时，权威机构或欧洲医疗代理机构应把报告主体所规定的制造过程和物质组合成医疗器械后的相关效用数据考虑在内。Where changes are made to an ancillary substance incorporated in a device, in particular related to its manufacturing process, the

28、notified body shall be informed of the changes and shall consult the relevant medicines competent authority (i.e. the one involved in the initial consultation) , in order to confirm that the quality and safety of the ancillary substance are maintained.当组合到医疗器械的辅助性物质发生变化时，特别是与之相关的制造过程发生变化时，应把这些变化通知到报

29、告主体且咨询相关医疗权威机构（例如首次咨询的机构），以确保辅助性物质的质量和安全得到保持。The competent authority shall take into account the data related to the usefulness of incorporation of the substance into the device as determined by the notified body, in ()Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 M

30、arch 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency (OJ L 136, 30.4.2004, p. 1) . Regulation as last amended by Regulation (EC) No 1901/2006.根据欧洲议会制定的第726/2004号（EC）规定第（*）条款和和欧

31、洲委员会2004年3月31日制定的关于用于人类和动物的医疗产品的授权和监督程序以及建立欧洲医疗代理机构（OJL 136，30.4.2004，p.1)的决议，权威机构应把报告主体所规定的制造过程和物质组合成医疗器械后的相关效用数据考虑在内。7.5The devices must be designed and manufactured in such a way as to reduce to a minimum the risks posed by substances leaking from the device. Special attention shall be given to s

32、ubstances which are carcinogenic, mutagenic or toxic to reproduction, in accordance with Annex I to Council Directive 67/548/EEC of 27 June 1967 on the approximation of laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances (*) . If parts of a device (or