mdr eu_2017_745 歐盟醫(yī)療器械最新法規(guī) (中英對照版)

1、<p>　　________________</p><p>　?。?）EEA相關(guān)性文本。</p><p>　歐盟官方公報中文版立法L117第60卷2017年5月5日</p><p><b>　　I</b></p><p><b>　　（立法法案）</b></p><p

2、><b>　　法規(guī)</b></p><p>　　歐洲議會和理事會于2017年4月5日簽發(fā)的關(guān)于醫(yī)療器械第2017/745號法規(guī)，修訂了第2001/83/EC號指令，第178/2002號（EU）法規(guī)和第1223/2009號（EU）法規(guī)，并廢除了理事會第90/385/EEC號和第93/42/EEC號指令</p><p>　?。‥EA相關(guān)性文本）</p>

3、<p>　　歐洲議會和歐盟委員會，</p><p>　　考慮到“歐盟運作條約”，特別是其中第114條和第168（4）（c）條規(guī)定，</p><p>　　并考慮到歐盟委員會提案，</p><p>　　于立法草案轉(zhuǎn)交各國議會后，</p><p>　　考慮到歐洲經(jīng)濟和社會委員會之意見（1），</p><p>　　

4、在咨詢地區(qū)委員之后，</p><p>　　根據(jù)一般立法程序運作（2），</p><p><b>　　鑒于：</b></p><p>　　理事會第90/385/EEC號指令（3）和理事會第93/42/EEC號指令（4）構(gòu)成有關(guān)醫(yī)療器械（不包括體外診斷醫(yī)療器械）的歐盟監(jiān)管框架。但需要對該指令進行大幅修訂，以便建立穩(wěn)健、透明、可預(yù)測和可持續(xù)的醫(yī)療器械

5、監(jiān)管框架，以確保高水平的安全和健康，同時為創(chuàng)新提供支持。</p><p>　　Council Directive 90/385/EEC (3) and Council Directive 93/42/EEC (4) constitute the Union regulatory framework for medical devices, other than in vit

6、ro diagnostic medical devices. However, a fundamental revision of those Directives is needed to establish a robust, transparent, predictable and sustainable regulatory framework for medical devices which ensures a high l

7、evel of safety and health whilst supporting innovation.</p><p>　　本法規(guī)旨在確保區(qū)域內(nèi)醫(yī)療器械市場的平穩(wěn)運作，在為患者和使用者提供高水平健康保護的基礎(chǔ)上，同時考慮到活躍于本行業(yè)的中小型企業(yè)利益。同時，本法規(guī)為醫(yī)療器械的質(zhì)量及安全性制定了較高標(biāo)準(zhǔn)，以滿足器械產(chǎn)品常見安全問題的管控。這兩個目標(biāo)相輔相成、不可分割地聯(lián)系在一起，并且在達成過程中沒有主次順序

8、。關(guān)于歐盟運作條約（TFEU）第114條，本法規(guī)融合了上市銷售以及將醫(yī)療器械及其附件投入歐盟市場的規(guī)則，這些規(guī)則可能受益于貨物自由流通原則。針對TFEU第168(4)(c)條，本法規(guī)通過確保臨床研究的數(shù)據(jù)的可靠性和穩(wěn)健性，來保障這些器械的質(zhì)量及安全，并保障參與臨床研究受試者的安全。</p><p>　　This Regulation aims to ensure the smooth functioning of

9、 the internal market as regards medical devices, taking as a base a high level of protection of health for patients and users, and taking into account the small- and medium-sized enterprises that are active in this secto

10、r. At the same time, this Regulation sets high standards of quality and safety for medical devices in order to meet common safety concerns as regards such products. Both objectives are being pursued simultaneously and ar

11、e in</p><p>　　_________________</p><p>　?。?）2013年2月14日意見（OJ C 133, 9.5.2013, p. 52）。</p><p>　?。?）2014年4月2日的歐洲議會立場（尚未在官方公告內(nèi)公布）以及2017年3月7日首次審閱時理事會的立場（尚未在官方公告內(nèi)公布）。</p><p>

12、　?。?）1990年6月20日簽發(fā)的關(guān)于成員國有關(guān)可植入醫(yī)療器械法律的理事會第90/38/EEC號指令（OJ L 331, 7.12.1998, p.1）。</p><p>　?。?）1993年6月14日簽發(fā)的關(guān)于醫(yī)療器械的理事會第93/42 EEC號指令（OJ L 169，12.7.1993，p. 1）。</p><p>　　（3）本法規(guī)并不尋求協(xié)調(diào)有關(guān)醫(yī)療器械投入使用后，在市場上進一

13、步供應(yīng)之規(guī)則，例如二手銷售。</p><p>　　This Regulation does not seek to harmonise rules relating to the further making available on the market of medical devices after they have already been put into service such as in the

14、 context of second-hand sales.</p><p>　?。?）應(yīng)大大加強現(xiàn)有監(jiān)管方法的關(guān)鍵要素，例如公告機構(gòu)監(jiān)管、符合性評估流程、臨床研究和臨床評價，警戒和市場監(jiān)管，同時引入確保醫(yī)療器械透明度和可追溯性之規(guī)定，以改善健康和安全性。</p><p>　　Key elements of the existing regulatory approach, such a

15、s the supervision of notified bodies, conformity assessment procedures, clinical investigations and clinical evaluation, vigilance and market surveillance should be significantly reinforced, whilst provisions ensuring tr

16、ansparency and traceability regarding medical devices should be introduced, to improve health and safety.</p><p>　?。?）如有可能，應(yīng)當(dāng)考慮到為醫(yī)療器械制定的國際指導(dǎo)準(zhǔn)則，特別是全球協(xié)調(diào)工作隊及其后續(xù)行動即“國際醫(yī)療器械監(jiān)管機構(gòu)論壇（IMDRF）”，以便推動世界范圍內(nèi)利于提高安全防護標(biāo)準(zhǔn)以及促進貿(mào)

17、易之相關(guān)法規(guī)的全球化進程，特別是關(guān)于唯一器械標(biāo)識、通用安全與性能要求、技術(shù)文件、分類標(biāo)準(zhǔn)、符合性評估流程和臨床證據(jù)等方面的規(guī)定。</p><p>　　To the extent possible, guidance developed for medical devices at international level, in particular in the context of the Global Har

18、monization Task Force (GHTF) and its follow-up initiative, the International Medical Devices Regulators Forum (IMDRF), should be taken into account to promote the global convergence of regulations which contributes to a

19、high level of safety protection worldwide, and to facilitate trade, in particular in the provisions on Unique Device Identification, general safety</p><p>　　（6）出于歷史原因，第90/385/EEC號指令所涵蓋的有源植入式醫(yī)療器械以及第93/42/EEC

20、號指令所涵蓋的其他醫(yī)療器械通過另外兩個單獨的法律進行管控。為簡化起見，經(jīng)過若干次修訂的兩項指令均應(yīng)替換為適用于除體外診斷醫(yī)療器械外所有醫(yī)療器械的單一立法法案。</p><p>　　For historical reasons, active implantable medical devices, covered by Directive 90/385/EEC, and other medical de

21、vices, covered by Directive 93/42/EEC, were regulated in two separate legal instruments. In the interest of simplification, both directives, which have been amended several times, should be replaced by a single legi

22、slative act applicable to all medical devices other than in vitro diagnostic medical devices.</p><p>　　本法規(guī)的適用范圍應(yīng)與其他相關(guān)產(chǎn)品的歐盟協(xié)調(diào)立法明確區(qū)分開，（如體外診斷醫(yī)療器械、醫(yī)藥產(chǎn)品、美容產(chǎn)品和食品）。因此，應(yīng)對歐洲議會和委員會第178/2002號法規(guī)（1）進行修訂，將醫(yī)療器械排除在其范圍之外。<

23、;/p><p>　　The scope of application of this Regulation should be clearly delimited from other Union harmonisation legislation concerning products, such as in vitro diagnostic medical devices, medicinal products,

24、 cosmetics and food. Therefore, Regulation (EC) No 178/2002 of the European Parliament and of the Council (5) should be amended to exclude medical devices from its scope.</p><p>　　成員國有責(zé)任逐

25、案例確認(rèn)，各產(chǎn)品是否屬于本法規(guī)范圍。為確保所有成員國的相關(guān)判斷力一致，特別是在灰區(qū)臨界情況下，在咨詢醫(yī)療器械協(xié)調(diào)小組（MDCG）后，應(yīng)允許委員會主動或經(jīng)成員國適時且有根據(jù)地請求，逐案決定某一具體產(chǎn)品、類別或產(chǎn)品組是否屬于本法規(guī)適用范圍。在審議涉及藥品、人體組織和細(xì)胞、生物滅活產(chǎn)品或食品之臨界案例所轄產(chǎn)品之監(jiān)管狀況時，委員會應(yīng)確保歐洲藥品管理局、歐洲化學(xué)品管理局和歐洲食品安全局的適當(dāng)咨詢水平。</p><p>　　

26、It should be the responsibility of the Member States to decide on a case-by-case basis whether or not a product falls within the scope of this Regulation. In order to ensure consistent qualification decisions in tha

27、t regard across all Member States, particularly with regard to borderline cases, the Commission should be allowed to, on its own initiative or at the duly substantiated request of a Member State, having consult

28、ed the Medical Device Coordination Group (‘MDCG’), decide on a case-by-case</p><p>　　由于在某些情況下醫(yī)療器械和美容產(chǎn)品難以區(qū)分，因此歐盟議會和理事會第1223/2009號法規(guī)（2）中也應(yīng)加入對某一產(chǎn)品法規(guī)狀況的歐盟范圍統(tǒng)一決議。</p><p>　　Since in some cases it is d

29、ifficult to distinguish between medical devices and cosmetic products, the possibility of taking a Union-wide decision regarding the regulatory status of a product should also be introduced in Regulation (EC) N

30、o 1223/2009 of the European Parliament and of the Council (6).</p><p>　　（10）藥械組合類產(chǎn)品將按照本法規(guī)或歐洲議會和理事會第2001/83/EC號指令（3）進行管理。在涉及該藥械組合產(chǎn)品的監(jiān)管活動中，在上市前評估咨詢及信息交換期間，兩項立法法案應(yīng)確保適當(dāng)?shù)南嗷リP(guān)聯(lián)。對于藥械組合產(chǎn)品，應(yīng)當(dāng)在該醫(yī)療產(chǎn)品上市許可背景下，充

31、分評估其是否符合本法規(guī)中規(guī)定的通用安全與性能要求。因此，應(yīng)修訂第2001/83/EC號指令。</p><p>　　Products which combine a medicinal product or substance and a medical device are regulated either under this Regulation or under Directive 2001/83

32、/EC of the European Parliament and of the Council. (7) The two legislative acts should ensure appropriate interaction in terms of consultations during pre-market assessment, and of exchange of information in the con

33、text of vigilance activities involving such combination products. For medicinal products that integrate a medical device part, compliance w</p><p>　　________________________</p><p>　　（1）歐洲議會和理事會

34、于2002年1月28日簽發(fā)的第178/2002號（EC）法規(guī)規(guī)定了食品法的一般原則和要求，設(shè)立了歐洲食品安全局并制定了食品安全方面的程序（OJ L 31，1.2.2002，p.1）。</p><p>　　（2）歐洲議會和理事會于2009年11月30日簽發(fā)的關(guān)于美容產(chǎn)品的第1223/2009號（EC）法規(guī)（OJ L 342，22.12.2009，p.59）。</p><p>　?。?）歐洲議

35、會和理事會于2001年11月6日簽發(fā)的關(guān)于人類藥用產(chǎn)品社區(qū)規(guī)則的第2001/83/EC號指令（OJ L 311,28.11.2001，p.67）。</p><p>　?。?1）對于非活性或處理為非活性的人類來源組織或細(xì)胞衍生物制造的特定產(chǎn)品，歐盟立法特別是歐盟議會和理事會第1394/2007號法規(guī)（1）和第2004/23/EC號指令（2）并不完善。此類產(chǎn)品應(yīng)屬于本法規(guī)管轄范圍，但前提是其應(yīng)符合醫(yī)療器械的定義或受

36、本法規(guī)管轄。</p><p>　　Union legislation, in particular Regulation (EC) No 1394/2007 of the European Parliament and of the Council (8) and Directive 2004/23/EC of the European Parliament an

37、d of the Council (9), is incomplete in respect of certain products manufactured utilising derivatives of tissues or cells of human origin that are non-viable or are rendered non-viable. Such products should come und

38、er the scope of this Regulation, provided they comply with the definition of a medical device or are covered by this Re</p><p>　?。?2）本法規(guī)應(yīng)涵蓋制造商聲稱僅具有美容目的或另一種非醫(yī)療目的，但在功能和風(fēng)險特征方面類似于醫(yī)療器械的特定產(chǎn)品組。為能使制造商證明此類產(chǎn)品的符合性，委員會應(yīng)

39、至少在應(yīng)用風(fēng)險管理時采用通用技術(shù)規(guī)范，并在必要時對安全性進行臨床評價。這些通用技術(shù)規(guī)范應(yīng)針對無醫(yī)療目的產(chǎn)品組制定，且不得用于具有醫(yī)療目的之類似器械的符合性評估。具有醫(yī)療和非醫(yī)療預(yù)期目的之器械應(yīng)當(dāng)同時滿足具有和不具有預(yù)期醫(yī)療目的之器械相關(guān)要求。</p><p>　　Certain groups of products for which a manufacturer claims only an aesthetic

40、 or another non-medical purpose but which are similar to medical devices in terms of functioning and risks profile should be covered by this Regulation. In order for manufacturers to be able to demonstrate the conformity

41、 of such products, the Commission should adopt common specifications at least with regard to application of risk management and, where necessary, clinical evaluation regarding safety. Such common specific</p><

42、p>　?。?3）由于第90/385/EEC和93/42/EEC號指令和本法規(guī)中明確排除含有人類或動物來源活組織或細(xì)胞的產(chǎn)品，應(yīng)當(dāng)澄清的是，含有或構(gòu)成自其他來源活體生物物質(zhì)或活體組織以實現(xiàn)或支持這些產(chǎn)品預(yù)期目的之產(chǎn)品也不在本法規(guī)管轄范圍內(nèi)。</p><p>　　As is the case for products that contain viable tissues or cells of human

43、or animal origin, that are explicitly excluded from Directives 90/385/EEC and 93/42/EEC and hence from this Regulation, it should be clarified that products that contain or consist of viable biological materials or

44、viable organisms of another origin in order to achieve or support the intended purpose of those products are not covered by this Regulation either.</p><p>　?。?4）歐洲議會和理事會第2002/98/EC號指令（3）設(shè)定的要求應(yīng)當(dāng)繼續(xù)適用。</p&g

45、t;<p>　　The requirements laid down in Directive 2002/98/EC of the European Parliament and of the Council (10) should continue to apply.</p><p>　?。?5）適用于器械的納米材料風(fēng)險和益處目前存在科學(xué)不確定性。為確保高水平的健康保護、貨物

46、自由流通和制造商的法律確定性，基于委員會第2011/696/EU號建議（4），有必要為納米材料引入一個統(tǒng)一定義，這一定義應(yīng)具有必要的靈活性，以使得這一定義適應(yīng)科學(xué)和技術(shù)進展以及后續(xù)歐盟和國際層面的監(jiān)管發(fā)展。在器械的設(shè)計和制造中，制造商在使用具有較高或中等體內(nèi)照射可能的納米顆粒時應(yīng)特別注意，這些器械應(yīng)接受最為嚴(yán)格的符合性評估程序。在法案試行期間對本法規(guī)中規(guī)定的相關(guān)要求的實施以及應(yīng)用，應(yīng)考慮相應(yīng)科學(xué)委員會的科學(xué)意見。</p>

47、<p>　　There is scientific uncertainty about the risks and benefits of nanomaterials used for devices. In order to ensure a high level of health protection, free movement of goods and legal certainty for manufacturer

48、s, it is necessary to introduce a uniform definition for nanomaterials based on Commission Recommendation 2011/696/EU (11), with the necessary flexibility to adapt that definition to scientific and technical pr

49、ogress and subsequent regulatory development at Union and international level. In</p><p>　?。?6）歐洲議會和理事會第2014/30/EU號指令（5）所論述的安全問題屬于本法規(guī)中規(guī)定的器械通用安全與性能要求的一部分。因此，本法規(guī)應(yīng)被視為與該指令有關(guān)的特別法。</p><p>　　Safety asp

50、ects addressed by Directive 2014/30/EU of the European Parliament and of the Council (12) are an integral part of the general safety and performance requirements laid down in this Regulation for devices. Conseq

51、uently, this Regulation should be considered a lex specialis in relation to that Directive.</p><p>　　（17）本法規(guī)應(yīng)包括關(guān)于發(fā)射離子輻射的器械的設(shè)計和制造要求，而不影響尋求其他目標(biāo)的理事會第2013/59/Euratom號指令（6）的適用性。</p><p>　　This Re

52、gulation should include requirements regarding the design and manufacture of devices emitting ionizing radiation without affecting the application of Council Directive 2013/59/Euratom (13) which pursues other o

53、bjectives.</p><p>　?。?8）本法規(guī)應(yīng)包括關(guān)于旨在防止職業(yè)傷害（包括輻射防護）的器械設(shè)計、安全與性能特性相關(guān)要求。</p><p>　　This Regulation should include requirements for devices' design, safety and performance characteristics which are

54、developed in such a way as to prevent occupational injuries, including protection from radiation.</p><p>　　______________________</p><p>　?。?）歐洲議會和理事會于2007年11月13日簽發(fā)的關(guān)于前沿療法醫(yī)藥產(chǎn)品的第1394/2007號（EC）法規(guī)和

55、修訂了第2001/83/EC號指令和第726/2004號（EC）法規(guī)（OJ L 324,10.12.2007，p. 121）。</p><p>　?。?）歐洲議會和理事會于2004年3月31日簽發(fā)的關(guān)于制定人體組織和細(xì)胞捐贈、采購、檢測、處理、保存、儲存和分配質(zhì)量和安全標(biāo)準(zhǔn)的第2004/23/EC號指令（OJ L 102，7.4.2004，p. 48）。</p><p>　　（3）歐洲議會

56、和理事會于2003年1月27日簽發(fā)的關(guān)于制定了人血和血液成分的收集、測試、處理、儲存和分配的質(zhì)量和安全標(biāo)準(zhǔn)的第2002/98/EC號指令（OJ L 33，8.2.2003，p. 30）。</p><p>　?。?）2011年10月18日簽發(fā)的關(guān)于納米材料定義的委員會第2011/696/EU號建議（OJ L 275,20.10.2011，p. 38）。</p><p>　　（5）2014年

57、2月26日歐洲議會和理事會第2014/30/EU號指令關(guān)于成員國有關(guān)電磁兼容性(OJ L 96, 29.3.2014. p. 79)。</p><p>　?。?）2013年12月5日簽發(fā)的理事會第2013/59/Euratom號指令規(guī)定了有關(guān)因離子輻射接觸所引起的危險防護的基本安全標(biāo)準(zhǔn)，并廢除尋求其他目標(biāo)的第89/618/Euratom號指令、第90/641/Euratom號指令、第96/29/Euratom號

58、指令、第97/43/Euratom號指令和第2003/122/Euratom號指令(OJ L 3, 17.1.2014, p. 1)。</p><p>　?。?9）有必要明確的是，當(dāng)制造商的軟件專用于醫(yī)療器械定義中所述的一種或多種醫(yī)學(xué)目的時，軟件本身可視為醫(yī)療器械，而用于一般目的的軟件，即使在醫(yī)療保健環(huán)境中使用，或用于健康應(yīng)用之軟件，均不視為醫(yī)療器械。作為器械或附件之軟件的資格評定不得依賴于這個軟件和器械之間的

59、物理位置或互連類型決定。</p><p>　　It is necessary to clarify that software in its own right, when specifically intended by the manufacturer to be used for one or more of the medical purposes set out in the definition of

60、 a medical device, qualifies as a medical device, while software for general purposes, even when used in a healthcare setting, or software intended for life-style and well-being purposes is not a medical device. The qual

61、ification of software, either as a device or an accessory, is independent of the software's loc</p><p>　?。?0）本法規(guī)中，關(guān)于器械本身、器械供應(yīng)、經(jīng)濟運營商、使用者和具體過程、符合性評估、臨床研究與證據(jù)、上市后監(jiān)管、警戒和市場監(jiān)管、標(biāo)準(zhǔn)和其他技術(shù)規(guī)范等定義應(yīng)當(dāng)符合歐盟和國際上本領(lǐng)域的既定做法，以提

62、高法律確定性。</p><p>　　The definitions in this Regulation, regarding devices themselves, the making available of devices, economic operators, users and specific processes, the conformity assessment, clinical inves

63、tigations and clinical evaluations, post-market surveillance, vigilance and market surveillance, standards and other technical specifications, should be aligned with well-established practice in the field at Union and in

64、ternational level in order to enhance legal certainty.</p><p>　　(21)應(yīng)明確指出，通過歐洲議會和理事會第2015/1535號指令（1）中所規(guī)定的信息服務(wù)，向歐盟人員提供的器械以及在商業(yè)活動范圍內(nèi)用于為歐盟內(nèi)人員提供診斷或治療服務(wù)的器械，當(dāng)在歐盟境內(nèi)上市或提供服務(wù)時，必須符合本法規(guī)要求。</p><p>　　It shou

65、ld be made clear that it is essential that devices offered to persons in the Union by means of information society services within the meaning of Directive (EU) 2015/1535 of the European Parliament and of the C

66、ouncil (14) and devices used in the context of a commercial activity to provide a diagnostic or therapeutic service to persons within the Union comply with the requirements of this Regulation, where the product in q

67、uestion is placed on the market or the service is provided in the Un</p><p>　　（22）為認(rèn)識到標(biāo)準(zhǔn)化在醫(yī)療器械領(lǐng)域中的重要作用，符合歐洲議會和理事會第1025/2012號法規(guī)（2）中規(guī)定的協(xié)調(diào)標(biāo)準(zhǔn)之相關(guān)證據(jù)，應(yīng)是制造商證明其產(chǎn)品符合通用安全與性能要求以及其他法律要求（如本法規(guī)所述質(zhì)量和風(fēng)險管理）的手段。</p><

68、;p>　　To recognise the important role of standardisation in the field of medical devices, compliance with harmonised standards as defined in Regulation (EU) No 1025/2012 of the European Parliament and of the

69、Council (15) should be a means for manufacturers to demonstrate conformity with the general safety and performance requirements and other legal requirements, such as those relating to quality and risk management, la

70、id down in this Regulation.</p><p>　　(23)歐洲議會和理事會第98/79/EC號指令（3）允許委員會對特定類別體外診斷醫(yī)療器械采用通用技術(shù)規(guī)范。在沒有協(xié)調(diào)標(biāo)準(zhǔn)或協(xié)調(diào)標(biāo)準(zhǔn)不充分的地區(qū)，委員會應(yīng)有權(quán)制定通用規(guī)范，以提供一種手段來符合本法規(guī)規(guī)定之通用安全與性能要求，以及臨床研究和臨床評估及/或上市后跟蹤等要求。</p><p>　　Directive&#

71、160;98/79/EC of the European Parliament and of the Council (16) allows the Commission to adopt common technical specifications for specific categories of in vitro diagnostic medical devices. In areas where no harmon

72、ised standards exist or where they are insufficient, the Commission should be empowered to lay down common specifications which provide a means of complying with the general safety and performance requirements, and the r

73、equirements for clinical investigations and clinical evalua</p><p>　　（24）在咨詢相關(guān)利益相關(guān)者并考慮歐洲和國際標(biāo)準(zhǔn)后，應(yīng)制定通用規(guī)范（“CS”）。</p><p>　　Common specifications (‘CS’) should be developed after consulting the rele

74、vant stakeholders and taking account of European and international standards.</p><p>　?。?5）適用于器械的規(guī)則應(yīng)酌情與“產(chǎn)品營銷新立法框架”保持一致，其中包括歐洲議會和理事會第765/2008號法規(guī)（4），和歐洲議會和理事會第768/2008/EC號決議（5）。</p><p>　　The rule

75、s applicable to devices should be aligned, where appropriate, with the New Legislative Framework for the Marketing of Products, which consists of Regulation (EC) No 765/2008 of the European Parliament and

76、of the Council (17) and Decision No 768/2008/EC of the European Parliament and of the Council (18).</p><p>　?。?6）針對進入歐盟市場的產(chǎn)品，歐洲委員會第765/2008號法規(guī)規(guī)定的歐盟市場監(jiān)管和控制規(guī)則，同樣適用于本法規(guī)所涵蓋的器械，但這不妨礙成員國自行選擇主管

77、機構(gòu)來執(zhí)行這些任務(wù)。</p><p>　　The rules on Union market surveillance and control of products entering the Union market laid down in Regulation (EC) No 765/2008 apply to devices covered by this Regulatio

78、n which does not prevent Member States from choosing the competent authorities to carry out those tasks.</p><p>　?。?7）根據(jù)“產(chǎn)品營銷新立法框架”，在不影響本法規(guī)不同部分規(guī)定的具體義務(wù)的情況下，明確規(guī)定不同經(jīng)濟運營商（包括進口商和經(jīng)銷商）的一般義務(wù)，加強對本法規(guī)要求的理解，從而提高相關(guān)

79、運營商的法規(guī)符合性。</p><p>　　It is appropriate to set out clearly the general obligations of the different economic operators, including importers and distributors, building on the New Legislative Framework for the M

80、arketing of Products, without prejudice to the specific obligations laid down in the various parts of this Regulation, to enhance understanding of the requirements laid down in this Regulation and thus to improve regulat

81、ory compliance by the relevant operators.</p><p>　　_____________________</p><p>　?。?）歐洲議會和理事會于2012年10月25日簽發(fā)的有關(guān)歐洲標(biāo)準(zhǔn)化的第1025/2012號指令，修訂了歐洲理事會第89/686/EEC和93/15/EEC號指令以及歐洲議會和理事會第94/9/EC、94/25/EC、95/1

82、6/EC、97/23/EC、98/34/EC、2004/22/EC、2007/23/EC、2009/23/EC和2009/105/EC號指令，并廢除了歐洲理事會第87/95/EEC號決議和歐洲議會和理事會第1673/2006/EC號決議（OJ L 316, 14.11.2012, p. 12）。</p><p>　　（2）歐洲議會和理事會于2012年10月25日簽發(fā)的有關(guān)歐洲標(biāo)準(zhǔn)化的第1025/2012號指令，修

83、訂了歐洲理事會第89/686/EEC和93/15/EEC號指令以及歐洲議會和理事會第94/9/EC、94/25/EC、95/16/EC、97/23/EC、98/34/EC、2004/22/EC、2007/23/EC、2009/23/EC和2009/105/EC號指令，并廢除了歐洲理事會第87/95/EEC號決議和歐洲議會和理事會第1673/2006/EC號決議（OJ L 316, 14.11.2012, p. 12）。</p>

84、;<p>　　（3）歐洲議會和理事會于2015年9月9日簽發(fā)的關(guān)于在信息服務(wù)技術(shù)標(biāo)準(zhǔn)和法規(guī)領(lǐng)域提供信息的流程的第2015/1535號指令（OJ L 241, 17.9.2015, p.1）。</p><p>　?。?）歐洲議會和理事會于2008年7月9日簽發(fā)的關(guān)于與產(chǎn)品營銷有關(guān)的認(rèn)證和市場監(jiān)管的要求的第765/2008號法規(guī)，廢除了第339/93號法規(guī) (OJ L 218, 13.8.2008,p.

85、 30).</p><p>　?。?）歐洲議會和理事會于2008年7月9日簽發(fā)的關(guān)于產(chǎn)品營銷通用框架的第768/2008/EC號決議，并廢除理事會第93/465/EEC號決議（OJ L 218, 13.8.2008, p. 82）。</p><p>　?。?8）就本法規(guī)而言，經(jīng)銷商的活動應(yīng)視為包括獲取、持有和供應(yīng)器械。</p><p>　　For the purp

86、ose of this Regulation, the activities of distributors should be deemed to include acquisition, holding and supplying of devices.</p><p>　?。?9）制造商的一些義務(wù)，例如臨床評價或警戒報告，僅為第90/385/EC和93/42/EEC號指令的附錄中列出之內(nèi)容，這些應(yīng)納入本法

87、規(guī)頒布條款中，以便于應(yīng)用。</p><p>　　Several of the obligations on manufacturers, such as clinical evaluation or vigilance reporting, that were set out only in the Annexes to Directives 90/385/EEC and 93/42

88、/EEC, should be incorporated into the enacting provisions of this Regulation to facilitate its application.</p><p>　?。?0）衛(wèi)生機構(gòu)應(yīng)可內(nèi)部（而不是在工業(yè)規(guī)模上）制造、修改和使用器械，從而解決目標(biāo)患者群體的具體需求，這些需求往往無法通過市場上適當(dāng)性能水平的等效醫(yī)療器械來滿足。在這種情況下，適當(dāng)

89、的做法是在本法規(guī)中規(guī)定特定條款的豁免，這就是關(guān)于僅在衛(wèi)生機構(gòu)（含醫(yī)院以及支持衛(wèi)生保健系統(tǒng)和/或解決患者需求但可能不會直接治療或照顧患者之實驗室和公共衛(wèi)生機構(gòu)等）內(nèi)部制造和使用器械的豁免條例，這樣本法規(guī)就可以適當(dāng)方式予以滿足。應(yīng)注意，衛(wèi)生機構(gòu)的概念不包括主要追求健康利益或健康生活方式的機構(gòu)，例如健身房、水療中心、健康與健身中心。因此，適用于衛(wèi)生機構(gòu)的豁免條例不適用于這些機構(gòu)。</p><p>　　Health in

90、stitutions should have the possibility of manufacturing, modifying and using devices in-house and thereby address, on a non-industrial scale, the specific needs of target patient groups which cannot be met at the appropr

91、iate level of performance by an equivalent device available on the market. In that context, it is appropriate to provide that certain rules of this Regulation, as regards medical devices manufactured and used only within

92、 health institutions, including hospitals as well a</p><p>　?。?1）鑒于自然人或法人可根據(jù)適用歐盟和國家法律，就缺陷器械造成的損害提出索賠，因此，可要求制造商采取適當(dāng)措施，就其在第85/374/EEC號指令（1）規(guī)定的潛在責(zé)任提供足夠的保險范圍。這些措施應(yīng)與器械的風(fēng)險等級、類型和企業(yè)規(guī)模成比例。在本文中，還應(yīng)規(guī)定有關(guān)主管機構(gòu)向可能因缺陷器械而受傷人

93、員提供信息的規(guī)則。</p><p>　　In view of the fact that natural or legal persons can claim compensation for damage caused by a defective device in accordance with applicable Union and national law, it is appropriate to

94、require manufacturers to have measures in place to provide sufficient financial coverage in respect of their potential liability under Council Directive 85/374/EEC (19). Such measures should be proportionate to

95、 the risk class, type of device and the size of the enterprise. In this context, it is also appropriat</p><p>　　（32）為確保批量生產(chǎn)的器械繼續(xù)符合本法規(guī)的要求，并且將生產(chǎn)的器械的使用經(jīng)驗納入生產(chǎn)過程中，所有制造商均應(yīng)具備質(zhì)量管理體系和上市后監(jiān)管體系，此類系統(tǒng)應(yīng)與上述器械的風(fēng)險級別和分類對應(yīng)。此外，

96、為盡可能降低器械相關(guān)的風(fēng)險或防止與之相關(guān)事故的發(fā)生，制造商應(yīng)建立風(fēng)險管理體系，以及報告事故和現(xiàn)場安全糾正措施的系統(tǒng)。</p><p>　　To ensure that devices manufactured in series production continue to be in conformity with the requirements of this Regulation and that exp

97、erience from the use of the devices they manufacture is taken into account for the production process, all manufacturers should have a quality management system and a post-market surveillance system in place which should

98、 be proportionate to the risk class and the type of the device in question. In addition, in order to minimize risks or prevent incidents rela</p><p>　?。?3）風(fēng)險管理體系應(yīng)與器械的臨床評估過程保持一致，并在該評估過程中反映，包括作為臨床研究、臨床評估和上市后臨

99、床跟蹤的一部分需解決的臨床風(fēng)險。風(fēng)險管理和臨床評估過程應(yīng)相互依存，并應(yīng)定期更新。</p><p>　　The risk management system should be carefully aligned with and reflected in the clinical evaluation for the device, including the clinical risks to be addre

100、ssed as part of clinical investigations, clinical evaluation and post-market clinical follow up. The risk management and clinical evaluation processes should be inter-dependent and should be regularly updated.</p>

101、<p>　　（34）應(yīng)確保由符合最低資格條件的負(fù)責(zé)法規(guī)符合性的人員在制造商組織內(nèi)進行醫(yī)療器械制造的監(jiān)督和控制以及上市后監(jiān)管和警戒活動。</p><p>　　It should be ensured that supervision and control of the manufacture of devices, and the post-market surveillance and vigil