MDR-EU-2017-745-歐盟醫(yī)療器械最新法規(guī)-(中英對(duì)照版)

1、精選優(yōu)質(zhì)文檔傾情為你奉上精選優(yōu)質(zhì)文檔傾情為你奉上專心專注專業(yè)專心專注專業(yè)精選優(yōu)質(zhì)文檔傾情為你奉上專心專注專業(yè)歐盟官方公報(bào)中文版立法L117第60卷2017年5月5日內(nèi)容 I 立法法案法規(guī)歐洲議會(huì)和理事會(huì)于2017年4月5日簽發(fā)的關(guān)于醫(yī)療器械第2017/745號(hào)法規(guī)，修訂了第2001/83/EC號(hào)指令，第178/2002號(hào)（EU）法規(guī)和第1223/2009號(hào)（EU）法規(guī)，并廢除了理事會(huì)第90/385/EEC號(hào)和第93/42/EEC號(hào)指令（1）1歐洲議會(huì)和理事會(huì)于2017年4月5日簽發(fā)的關(guān)于體外診斷醫(yī)療器械第2017/746號(hào)（EU）法規(guī)并廢除了第98/79/EC號(hào)指令和理事會(huì)第2010/227/

2、EU號(hào)決議176_（1）EEA相關(guān)性文本。以淺色字體打印標(biāo)題的法案均為涉及農(nóng)業(yè)日常管理的法案，一般在有限期內(nèi)有效。所有其他法案的標(biāo)題均以粗體打印，并以星號(hào)開頭。I（立法法案）法規(guī)歐洲議會(huì)和理事會(huì)于2017年4月5日簽發(fā)的關(guān)于醫(yī)療器械第2017/745號(hào)法規(guī)，修訂了第2001/83/EC號(hào)指令，第178/2002號(hào)（EU）法規(guī)和第1223/2009號(hào)（EU）法規(guī)，并廢除了理事會(huì)第90/385/EEC號(hào)和第93/42/EEC號(hào)指令（EEA相關(guān)性文本）歐洲議會(huì)和歐盟委員會(huì)，考慮到“歐盟運(yùn)作條約”，特別是其中第114條和第168（4）（c）條規(guī)定，并考慮到歐盟委員會(huì)提案，于立法草案轉(zhuǎn)交各國(guó)議會(huì)后，考慮

3、到歐洲經(jīng)濟(jì)和社會(huì)委員會(huì)之意見（1），在咨詢地區(qū)委員之后，根據(jù)一般立法程序運(yùn)作（2），鑒于：理事會(huì)第90/385/EEC號(hào)指令（3）和理事會(huì)第93/42/EEC號(hào)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(duì)該指令進(jìn)行大幅修訂，以便建立穩(wěn)健、透明、可預(yù)測(cè)和可持續(xù)的醫(yī)療器械監(jiān)管框架，以確保高水平的安全和健康，同時(shí)為創(chuàng)新提供支持。Council Directive90/385/EEC and Council Directive93/42/EEC constitute the Union regulatory framework for medical devices,

4、other than in vitro 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 level of safety and health whilst supporting innovation.本法規(guī)旨在確保區(qū)

5、域內(nèi)醫(yī)療器械市場(chǎng)的平穩(wěn)運(yùn)作，在為患者和使用者提供高水平健康保護(hù)的基礎(chǔ)上，同時(shí)考慮到活躍于本行業(yè)的中小型企業(yè)利益。同時(shí)，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(wèn)題的管控。這兩個(gè)目標(biāo)相輔相成、不可分割地聯(lián)系在一起，并且在達(dá)成過(guò)程中沒有主次順序。關(guān)于歐盟運(yùn)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(chǎng)的規(guī)則，這些規(guī)則可能受益于貨物自由流通原則。針對(duì)TFEU第168(4)(c)條，本法規(guī)通過(guò)確保臨床研究的數(shù)據(jù)的可靠性和穩(wěn)健性，來(lái)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。This Regulation aims to e

6、nsure the smooth functioning of 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 sector. At the same time, this Regulation sets high st

7、andards 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 are inseparably linked whilst one not being secondary to the other. As regards Article114 of the Treaty on the Functioning of the E

8、uropean Union (TFEU), this Regulation harmonises the rules for the placing on the market and putting into service of medical devices and their accessories on the Union market thus allowing them to benefit from the principle of free movement of goods. As regards Article168(4)(c)TFEU, this Regulation

9、sets high standards of quality and safety for medical devices by ensuring, among other things, that data generated in clinical investigations are reliable and robust and that the safety of the subjects participating in a clinical investigation is protected._（1）2013年2月14日意見（OJ C 133, 9.5.2013, p. 52）

10、。（2）2014年4月2日的歐洲議會(huì)立場(chǎng)（尚未在官方公告內(nèi)公布）以及2017年3月7日首次審閱時(shí)理事會(huì)的立場(chǎng)（尚未在官方公告內(nèi)公布）。（3）1990年6月20日簽發(fā)的關(guān)于成員國(guó)有關(guān)可植入醫(yī)療器械法律的理事會(huì)第90/38/EEC號(hào)指令（OJ L 331, 7.12.1998, p.1）。（4）1993年6月14日簽發(fā)的關(guān)于醫(yī)療器械的理事會(huì)第93/42 EEC號(hào)指令（OJ L 169，12.7.1993，p. 1）。（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(chǎng)上進(jìn)一步供應(yīng)之規(guī)則，例如二手銷售。This Regulation does not seek to harmonise rules

11、 relating to the further making available on the market of medical devices after they have already been put into service such as in the context of second-hand sales.（4）應(yīng)大大加強(qiáng)現(xiàn)有監(jiān)管方法的關(guān)鍵要素，例如公告機(jī)構(gòu)監(jiān)管、符合性評(píng)估流程、臨床研究和臨床評(píng)價(jià)，警戒和市場(chǎng)監(jiān)管，同時(shí)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。Key elements of the existing regulatory approach

12、, such as the supervision of notified bodies, conformity assessment procedures, clinical investigations and clinical evaluation, vigilance and market surveillance should be significantly reinforced, whilst provisions ensuring transparency and traceability regarding medical devices should be introduc

13、ed, to improve health and safety.（5）如有可能，應(yīng)當(dāng)考慮到為醫(yī)療器械制定的國(guó)際指導(dǎo)準(zhǔn)則，特別是全球協(xié)調(diào)工作隊(duì)及其后續(xù)行動(dòng)即“國(guó)際醫(yī)療器械監(jiān)管機(jī)構(gòu)論壇（IMDRF）”，以便推動(dòng)世界范圍內(nèi)利于提高安全防護(hù)標(biāo)準(zhǔn)以及促進(jìn)貿(mào)易之相關(guān)法規(guī)的全球化進(jìn)程，特別是關(guān)于唯一器械標(biāo)識(shí)、通用安全與性能要求、技術(shù)文件、分類標(biāo)準(zhǔn)、符合性評(píng)估流程和臨床證據(jù)等方面的規(guī)定。To the extent possible, guidance developed for medical devices at international level, in particular in the cont

14、ext of the Global Harmonization 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 high level of safety protection worldwide, and to facilitat

15、e trade, in particular in the provisions on Unique Device Identification, general safety and performance requirements, technical documentation, classification rules, conformity assessment procedures and clinical investigations.（6）出于歷史原因，第90/385/EEC號(hào)指令所涵蓋的有源植入式醫(yī)療器械以及第93/42/EEC號(hào)指令所涵蓋的其他醫(yī)療器械通過(guò)另外兩個(gè)單獨(dú)的法律

16、進(jìn)行管控。為簡(jiǎn)化起見，經(jīng)過(guò)若干次修訂的兩項(xiàng)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。For historical reasons, active implantable medical devices, covered by Directive90/385/EEC, and other medical devices, covered by Directive93/42/EEC, were regulated in two separate legal instruments. In the interest of simplification, both direc

17、tives, which have been amended several times, should be replaced by a single legislative act applicable to all medical devices other than in vitro diagnostic medical devices.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(duì)歐洲議會(huì)和委員會(huì)第178/2002號(hào)法規(guī)（1）進(jìn)行修訂，將醫(yī)療器械排除在其范圍之外。The scope of application

18、of this Regulation should be clearly delimited from other Union harmonisation legislation concerning products, such as in vitro diagnostic medical devices, medicinal products, cosmetics and food. Therefore, Regulation(EC)No178/2002 of the European Parliament and of the Council should be amended to e

19、xclude medical devices from its scope.成員國(guó)有責(zé)任逐案例確認(rèn)，各產(chǎn)品是否屬于本法規(guī)范圍。為確保所有成員國(guó)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(huì)主動(dòng)或經(jīng)成員國(guó)適時(shí)且有根據(jù)地請(qǐng)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(shí)，委員會(huì)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。It should be the responsibility of the MemberStates to dec

20、ide 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 that regard across all MemberStates, particularly with regard to borderline cases, the Commission should be allowed to, on its own initiative or at

21、 the duly substantiated request of a MemberState, having consulted the Medical Device Coordination Group (MDCG), decide on a case-by-case basis whether or not a specific product, category or group of products falls within the scope of this Regulation. When deliberating on the regulatory status of pr

22、oducts in borderline cases involving medicinal products, human tissues and cells, biocidal products or food products, the Commission should ensure an appropriate level of consultation of the European Medicines Agency(EMA), the European Chemicals Agency and the European Food Safety Authority, as rele

23、vant.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(huì)和理事會(huì)第1223/2009號(hào)法規(guī)（2）中也應(yīng)加入對(duì)某一產(chǎn)品法規(guī)狀況的歐盟范圍統(tǒng)一決議。Since in some cases it is difficult 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 Reg

24、ulation(EC)No1223/2009 of the European Parliament and of the Council.（10）藥械組合類產(chǎn)品將按照本法規(guī)或歐洲議會(huì)和理事會(huì)第2001/83/EC號(hào)指令（3）進(jìn)行管理。在涉及該藥械組合產(chǎn)品的監(jiān)管活動(dòng)中，在上市前評(píng)估咨詢及信息交換期間，兩項(xiàng)立法法案應(yīng)確保適當(dāng)?shù)南嗷リP(guān)聯(lián)。對(duì)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，充分評(píng)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(hào)指令。Products which combine a medicinal product or substance and a

25、 medical device are regulated either under this Regulation or under Directive2001/83/EC of the European Parliament and of the Council. The two legislative acts should ensure appropriate interaction in terms of consultations during pre-market assessment, and of exchange of information in the context

26、of vigilance activities involving such combination products. For medicinal products that integrate a medical device part, compliance with the general safety and performance requirements laid down in this Regulation for the device part should be adequately assessed in the context of the marketing aut

27、horisation for such medicinal products. Directive2001/83/EC should therefore be amended._（1）歐洲議會(huì)和理事會(huì)于2002年1月28日簽發(fā)的第178/2002號(hào)（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）。（2）歐洲議會(huì)和理事會(huì)于2009年11月30日簽發(fā)的關(guān)于美容產(chǎn)品的第1223/2009號(hào)（EC）法規(guī)（OJ L 342，22.12.2009，p.59）。（3）歐洲議會(huì)和理事會(huì)于2001年11月6日簽發(fā)的關(guān)于人類藥用產(chǎn)

28、品社區(qū)規(guī)則的第2001/83/EC號(hào)指令（OJ L 311,28.11.2001，p.67）。（11）對(duì)于非活性或處理為非活性的人類來(lái)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(huì)和理事會(huì)第1394/2007號(hào)法規(guī)（1）和第2004/23/EC號(hào)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)療器械的定義或受本法規(guī)管轄。Union legislation, in particular Regulation(EC)No1394/2007 of the European Parliament and of the Council and Directive2004/2

29、3/EC of the European Parliament and of the Council, 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 under the scope of this Regulation, provided they comply w

30、ith the definition of a medical device or are covered by this Regulation.（12）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(xiǎn)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(huì)應(yīng)至少在應(yīng)用風(fēng)險(xiǎn)管理時(shí)采用通用技術(shù)規(guī)范，并在必要時(shí)對(duì)安全性進(jìn)行臨床評(píng)價(jià)。這些通用技術(shù)規(guī)范應(yīng)針對(duì)無(wú)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(píng)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(shí)滿足具有和不具有預(yù)期醫(yī)療目的之器械相關(guān)要求。Certain groups of products f

31、or which a manufacturer claims only an aesthetic 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 of such products, the Commissio

32、n should adopt common specifications at least with regard to application of risk management and, where necessary, clinical evaluation regarding safety. Such common specifications should be developed specifically for a group of products without an intended medical purpose and should not be used for c

33、onformity assessment of the analogous devices with a medical purpose. Devices with both a medical and a non-medical intended purpose should fulfil both the requirements applicable to devices with, and to devices without, an intended medical purpose.（13）由于第90/385/EEC和93/42/EEC號(hào)指令和本法規(guī)中明確排除含有人類或動(dòng)物來(lái)源活組織

34、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(lái)源活體生物物質(zhì)或活體組織以實(shí)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)。As is the case for products that contain viable tissues or cells of human or animal origin, that are explicitly excluded from Directives90/385/EEC and 93/42/EEC and hence from this Regulation, it should be clarified that products that c

35、ontain or consist of viable biological materials or viable organisms of another origin in order to achieve or support the intended purpose of those products are not covered by this Regulation either.（14）歐洲議會(huì)和理事會(huì)第2002/98/EC號(hào)指令（3）設(shè)定的要求應(yīng)當(dāng)繼續(xù)適用。The requirements laid down in Directive2002/98/EC of the Eur

36、opean Parliament and of the Council should continue to apply.（15）適用于器械的納米材料風(fēng)險(xiǎn)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(hù)、貨物自由流通和制造商的法律確定性，基于委員會(huì)第2011/696/EU號(hào)建議（4），有必要為納米材料引入一個(gè)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(jìn)展以及后續(xù)歐盟和國(guó)際層面的監(jiān)管發(fā)展。在器械的設(shè)計(jì)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(shí)應(yīng)特別注意，這些器械應(yīng)接受最為嚴(yán)格的符合性評(píng)估程序。在法案試行期間對(duì)本法規(guī)中規(guī)定的相關(guān)要求的實(shí)施以及應(yīng)用，應(yīng)考慮

37、相應(yīng)科學(xué)委員會(huì)的科學(xué)意見。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 manufacturers, it is necessary to introduce a uniform definition for nanomaterials based o

38、n Commission Recommendation2011/696/EU, with the necessary flexibility to adapt that definition to scientific and technical progress and subsequent regulatory development at Union and international level. In the design and manufacture of devices, manufacturers should take special care when using nan

39、oparticles for which there is a high or medium potential for internal exposure. Such devices should be subject to the most stringent conformity assessment procedures. In preparation of implementing acts regulating the practical and uniform application of the corresponding requirements laid down in t

40、his Regulation, the relevant scientific opinions of the relevant scientific committees should be taken into account.（16）歐洲議會(huì)和理事會(huì)第2014/30/EU號(hào)指令（5）所論述的安全問(wèn)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。Safety aspects addressed by Directive2014/30/EU of the European Parliament and of the Council are an

41、integral part of the general safety and performance requirements laid down in this Regulation for devices. Consequently, this Regulation should be considered a lexspecialis in relation to that Directive.（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(jì)和制造要求，而不影響尋求其他目標(biāo)的理事會(huì)第2013/59/Euratom號(hào)指令（6）的適用性。This Regulation should inc

42、lude requirements regarding the design and manufacture of devices emitting ionizing radiation without affecting the application of Council Directive2013/59/Euratom which pursues other objectives.（18）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(hù)）的器械設(shè)計(jì)、安全與性能特性相關(guān)要求。This Regulation should include requirements for devices des

43、ign, safety and performance characteristics which are developed in such a way as to prevent occupational injuries, including protection from radiation._（1）歐洲議會(huì)和理事會(huì)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(hào)（EC）法規(guī)和修訂了第2001/83/EC號(hào)指令和第726/2004號(hào)（EC）法規(guī)（OJ L 324,10.12.2007，p. 121）。（2）歐洲議會(huì)和理事會(huì)于2004年3月31日簽發(fā)的關(guān)于制定人

44、體組織和細(xì)胞捐贈(zèng)、采購(gòu)、檢測(cè)、處理、保存、儲(chǔ)存和分配質(zhì)量和安全標(biāo)準(zhǔn)的第2004/23/EC號(hào)指令（OJ L 102，7.4.2004，p. 48）。（3）歐洲議會(huì)和理事會(huì)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(cè)試、處理、儲(chǔ)存和分配的質(zhì)量和安全標(biāo)準(zhǔn)的第2002/98/EC號(hào)指令（OJ L 33，8.2.2003，p. 30）。（4）2011年10月18日簽發(fā)的關(guān)于納米材料定義的委員會(huì)第2011/696/EU號(hào)建議（OJ L 275,20.10.2011，p. 38）。（5）2014年2月26日歐洲議會(huì)和理事會(huì)第2014/30/EU號(hào)指令關(guān)于成員國(guó)有關(guān)電磁兼容性(OJ L 9

45、6, 29.3.2014. p. 79)。（6）2013年12月5日簽發(fā)的理事會(huì)第2013/59/Euratom號(hào)指令規(guī)定了有關(guān)因離子輻射接觸所引起的危險(xiǎn)防護(hù)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(hào)指令、第90/641/Euratom號(hào)指令、第96/29/Euratom號(hào)指令、第97/43/Euratom號(hào)指令和第2003/122/Euratom號(hào)指令(OJ L 3, 17.1.2014, p. 1)。（19）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(shí)，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

46、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(píng)定不得依賴于這個(gè)軟件和器械之間的物理位置或互連類型決定。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 a medical device, qualifies as a medical device, while s

47、oftware 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 qualification of software, either as a device or an accessory, is independent of the softwares location or the type of interconnection betwee

48、n the software and a device.（20）本法規(guī)中，關(guān)于器械本身、器械供應(yīng)、經(jīng)濟(jì)運(yùn)營(yíng)商、使用者和具體過(guò)程、符合性評(píng)估、臨床研究與證據(jù)、上市后監(jiān)管、警戒和市場(chǎng)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(guó)際上本領(lǐng)域的既定做法，以提高法律確定性。The definitions in this Regulation, regarding devices themselves, the making available of devices, economic operators, users and specific processes, the conformity asse

49、ssment, clinical investigations 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 international level in order to enhance legal certainty.(21)

50、應(yīng)明確指出，通過(guò)歐洲議會(huì)和理事會(huì)第2015/1535號(hào)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(dòng)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(shí)，必須符合本法規(guī)要求。It should 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

51、Parliament and of the Council 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 question is placed on the market or the service is provided in the U

52、nion.（22）為認(rèn)識(shí)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(huì)和理事會(huì)第1025/2012號(hào)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(xiǎn)管理）的手段。To recognise the important role of standardisation in the field of medical devices, compliance with harmonised standards as defined in Regulation (EU)No1025/2012 of the European Parl

53、iament and of the Council 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, laid down in this Regulation.(23)歐洲議會(huì)和理事會(huì)第98/79/EC號(hào)指令（3）允許委員會(huì)對(duì)特定類別體外診斷醫(yī)療器械

54、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(huì)應(yīng)有權(quán)制定通用規(guī)范，以提供一種手段來(lái)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(píng)估及/或上市后跟蹤等要求。Directive98/79/EC of the European Parliament and of the Council allows the Commission to adopt common technical specifications for specific categories of in vitro diagnostic medical devices. In areas where no h

55、armonised 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 requirements for clinical investigations and clinical evaluation and/or post

56、-market clinical follow-up, laid down in this Regulation.（24）在咨詢相關(guān)利益相關(guān)者并考慮歐洲和國(guó)際標(biāo)準(zhǔn)后，應(yīng)制定通用規(guī)范（“CS”）。Common specifications (CS) should be developed after consulting the relevant stakeholders and taking account of European and international standards.（25）適用于器械的規(guī)則應(yīng)酌情與“產(chǎn)品營(yíng)銷新立法框架”保持一致，其中包括歐洲議會(huì)和理事會(huì)第765/2008號(hào)

57、法規(guī)（4），和歐洲議會(huì)和理事會(huì)第768/2008/EC號(hào)決議（5）。The rules applicable to devices should be aligned, where appropriate, with the New Legislative Framework for the Marketing of Products, which consists of Regulation(EC)No765/2008 of the European Parliament and of the Council and DecisionNo768/2008/EC of the European

58、 Parliament and of the Council.（26）針對(duì)進(jìn)入歐盟市場(chǎng)的產(chǎn)品，歐洲委員會(huì)第765/2008號(hào)法規(guī)規(guī)定的歐盟市場(chǎng)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(guó)自行選擇主管機(jī)構(gòu)來(lái)執(zhí)行這些任務(wù)。The rules on Union market surveillance and control of products entering the Union market laid down in Regulation(EC)No765/2008 apply to devices covered by this Regulation which does

59、not prevent MemberStates from choosing the competent authorities to carry out those tasks.（27）根據(jù)“產(chǎn)品營(yíng)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(jì)運(yùn)營(yíng)商（包括進(jìn)口商和經(jīng)銷商）的一般義務(wù)，加強(qiáng)對(duì)本法規(guī)要求的理解，從而提高相關(guān)運(yùn)營(yíng)商的法規(guī)符合性。It is appropriate to set out clearly the general obligations of the different economic operators, including impor

60、ters and distributors, building on the New Legislative Framework for the Marketing 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 regulatory co