電話：021-51661637
QQ：2823435862
郵箱：13816273757@qq.com
地址：上海市閔行區滬閔路8075號醫療器械指令更改的分析(針對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.
本質上講，這份新指令是自1993年起,對醫療器械指令的第一個重大的修改，在2010年3月強制執行之前，你們需要好好準備它相應的改變。本文是重要變化的簡要概述。
1. 所有器械都將需要臨床數據,包括一類產品.
新指令強加了形成"臨床證據"更為嚴格的要求,并要求當局強制實施。 新指令包括了"臨床數據"的定義，基本要求根據附件X包括臨床評估的要求，有明顯變化。 我們強烈建議你評審附件X的變化.
2.記錄至少要保持五年以上.
記錄保存時間不得小于產品使用周期或自生產之日起五年以備檢查.對植入設備,記錄至少需要保存自最后的產品生產之日起15年.
3.一類(無菌和測量)設備現可以選擇附錄II.
一類(無菌和測量)設備現可以有更多靈活的合格評定程序供選擇.
4.外包的設計和生產活動須更嚴格的監視.
如果設備的設計和生產是由第三方來完成,你則必須證明你有足夠的控制以確保供應商質量體系的持續有效性.
5.設計文檔的嚴格檢驗
公告機構將需要根據行業標準的統計技術以及設備相應的風險, 對指定設備的代表樣品進行設計文檔檢驗.
6.歐盟授權代表的指定要更明確地記錄
授權代表被委任在滿足適于所有類別設備的指令方面, 代表生產者行動,及被聯系.
7.軟件被明確定義為有源醫療器械
不管軟件是作為設備和一部分還是單獨產品, 軟件的確認都是一項基本要求.
8.定制設備也需要進行售后監督.
定制設備也將需要進行售后監督并向主管當局報告.
9.使用說明書版本必須受控.
在適用處,新指令要求使用說明書的發布日期或最新的版本號必須明確指出.
10.產品劃分
如果一個產品要作為醫療產品或設備分類,將根據主要作用方式來確定,而不是預期用途.
11. 擴大中央循環系統的定義
現在包括vessels aortic arch (arcus aortae) and descending aorta (aorta descendens) to the aortic bifurcation (bifurcatio aortae)在內. 任何與這些導管有關的設備都將被認為是三類產品.
12.擴大連續使用的定義
現在包括一個設備被停用或移走,被另一相同的設備所代替的情況. 都將影響特定設備的分類.
13. 歐洲數據庫
現在與臨床研究相關的數據,都將收集入歐洲數據庫,并在主管當局之間共享. 這個數據庫還包括注冊信息, 授權代表, 證書有警戒數據. 數據必須按標準格式提交, 指令規定數據庫必須在2012年9月前投入運作.
14. 人體組織
接觸人體組織, 血液血漿的設備將劃為指令2001/83/EC的范圍并作為三類器械.
以上的更改是對醫療器械指令(93/42/EEC)最主要的更改.然而2007/47/EC也影響有源植入設備. 同樣新指令明確規定了體外診斷試劑被明確排除在98/8/EC之外.
