医疗器械指令更改的分析(针对2007/47/EC)中英文

Recently, we told you about a new Directive (2007/47/EC) that will affect all manufacturers selling medical devices in Europe. If you missed that issue of the eJournal, you can read it here.


Essentially, this new Directive is the first significant modification to the Medical Device Directive since 1993 and there are several changes you may need to prepare for WELL BEFORE it becomes mandatory in March 2010. Here is a brief overview of major changes.


1. Clinical data now required for ALL devices, including Class I
The new Directive imposes more stringent requirements as to what constitutes "clinical evidence" and mandates stronger enforcement by authorities. The definition of "clinical data" is included and the Essential Requirements includes a requirement for Clinical Evaluation according to Annex X, which has been significantly amended. We highly recommend you review the changes to Annex X.


2. Records must be retained for 5+ years
Records must now be maintained for inspection by the Competent Authorities for the useful life of the product or 5 years from date of manufacture, whichever is greater. For implantable devices, records need to be kept for 15 years from the time the last product was manufactured.


3. Class I (Sterile and Measuring) devices may now choose Annex II
Class I Sterile and Measuring devices will have more flexibility to select a route to compliance as they will be given the option to select a full quality assurance conformity assessment module.


4. Outsourced design and manufacturing must be more closely monitored
If the design or manufacturing of a device is done by a third party, you must demonstrate that you have adequate controls in place to ensure the continued efficient operation of the supplier's quality system.


5. Closer inspection of design documentation
Notified Bodies will be required to perform an inspection of design documentation for a representative sample of devices using industry standard statistical techniques and commensurate with the risk of the device.


6. Appointment of an Authorized Representative (AR) explicitly noted
The AR gets a mandate to act, and be contacted, in lieu of the manufacturer in terms of meeting the obligations by the Directives for all classes of devices.


7. Software is now clearly defined as an active medical device
It does not matter whether the software is integral with the device or is a standalone product. Software validation will also be an Essential Requirement.


8. Custom devices now subject to post market surveillance
Custom devices will now require a post-market surveillance system that is reportable to Competent Authorities.


9. Instructions for Use (IFU) must now be revision controlled
Where appropriate, the new Directive states that the date of issue or latest revision of the IFU must be clearly indicated.


10. Borderline products
Whether a product is classified as a medicinal product or device will now be determined by the Primary Mode of Action rather than by the Intended Use!


11. Definition of central circulatory system has been expanded
Now includes the vessels aortic arch (arcus aortae) and descending aorta (aorta descendens) to the aortic bifurcation (bifurcatio aortae). Any devices that come in contact with these vessels will now be considered Class III.


12. Definition of continuous use has been expanded
Now includes situations where a device, upon discontinuation or removal, is replaced immediately by the same or with an identical device. This could impact the classification of certain devices.


13. European databank
Data related to clinical investigations will now be collected for the European databank and shared among Competent Authorities. The databank will also include information on registration, Authorized Representative, certificates and vigilance data. The data must be submitted in a standardized format, yet to be determined. The Directive states that the databank must be operational by September 2012.


14. Human tissue
Devices that incorporate human tissue, blood or plasma will fall within the scope of Directive 2001/83/EC and be considered Class III.


The changes noted above mostly impact the Medical Device Directive. However, Directive 2007/47/EC also impacts the Active Implantable Medical Device Directive (90/385/EEC) which was adopted in 1990 before the MDD. Also, the new Directive clearly states that IVDs are specifically excluded from Directive 98/8/EC on Biocides, eliminating confusion as to which Directive applies.


This is a very high level summary of some of the most important changes. If you would like to read it yourself, please click here to download a PDF copy of Directive 2007/47/EC.
 
本质上讲，这份新指令是自1993年起,对医疗器械指令的第一个重大的修改，在2010年3月强制执行之前，你们需要好好准备它相应的改变。本文是重要变化的简要概述。


1. 所有器械都将需要临床数据,包括一类产品.
新指令强加了形成"临床证据"更为严格的要求,并要求当局强制实施。 新指令包括了"临床数据"的定义，基本要求根据附件X包括临床评估的要求，有明显变化。 我们强烈建议你评审附件X的变化.


2.记录至少要保持五年以上.
记录保存时间不得小于产品使用周期或自生产之日起五年以备检查.对植入设备,记录至少需要保存自最后的产品生产之日起15年.


3.一类(无菌和测量)设备现可以选择附录II.
一类(无菌和测量)设备现可以有更多灵活的合格评定程序供选择.


4.外包的设计和生产活动须更严格的监视.
如果设备的设计和生产是由第三方来完成,你则必须证明你有足够的控制以确保供应商质量体系的持续有效性.


5.设计文档的严格检验
公告机构将需要根据行业标准的统计技术以及设备相应的风险, 对指定设备的代表样品进行设计文档检验.


6.欧盟授权代表的指定要更明确地记录
授权代表被委任在满足适于所有类别设备的指令方面, 代表生产者行动,及被联系.


7.软件被明确定义为有源医疗器械
不管软件是作为设备和一部分还是单独产品, 软件的确认都是一项基本要求.


8.定制设备也需要进行售后监督.
定制设备也将需要进行售后监督并向主管当局报告.


9.使用说明书版本必须受控.
在适用处,新指令要求使用说明书的发布日期或最新的版本号必须明确指出.


10.产品划分
如果一个产品要作为医疗产品或设备分类,将根据主要作用方式来确定,而不是预期用途.


11. 扩大中央循环系统的定义
现在包括vessels aortic arch (arcus aortae) and descending aorta (aorta descendens) to the aortic bifurcation (bifurcatio aortae)在内. 任何与这些导管有关的设备都将被认为是三类产品.


12.扩大连续使用的定义
现在包括一个设备被停用或移走,被另一相同的设备所代替的情况. 都将影响特定设备的分类.


13. 欧洲数据库
现在与临床研究相关的数据,都将收集入欧洲数据库,并在主管当局之间共享. 这个数据库还包括注册信息, 授权代表, 证书有警戒数据. 数据必须按标准格式提交, 指令规定数据库必须在2012年9月前投入运作.


14. 人体组织
接触人体组织, 血液血浆的设备将划为指令2001/83/EC的范围并作为三类器械.


以上的更改是对医疗器械指令(93/42/EEC)最主要的更改.然而2007/47/EC也影响有源植入设备. 同样新指令明确规定了体外诊断试剂被明确排除在98/8/EC之外.