所有进入欧盟市场的医疗器械都必须进行医疗器械CE认证，医疗器械需要满足的CE指令有Active Implantable Medical Devices《有源植入性医疗器械指令》(AIMDD, 90/385/EEC)、Medical devices《医疗器械指令》(MDD,93/42/EEC)和In vitro diagnostic medical devices体外诊断器械指令(IVDD, 98/79/EC)。
欧洲医疗产品CE认证指令如下： Active implantable medical devices
In vitro diagnostic medical devices
Medical devices (MDD)
医疗器械怎样取得“CE认证标志”
以下以取得CE认证为例说明：
产品要顺利通过CE认证，需要做好三方面的工作。
第一，收集与认证产品有关的欧盟技术法规和欧盟（EN）标准，通过消化、吸收、纳入企业产品标准。
第二，企业严格按照以上产品标准组织生产，也就是把上述技术法规和EN标准的要求，贯彻到企业产品的设计开发和生产制造的全过程。
第三，企业必须按照ISO9000 ISO13485标准建和维护质量体系，并取得ISO9000 ISO13485认证。
获得CE标志的一般程序
目前国内的一些医疗器械厂家（特别是一些乡镇企业）对医疗器械指令不甚了解，不知如何着手申请CE标志。为此我们简单地介绍获得CE标志所需步骤如下：
一、分析器械及特点，确定它是否在指令的范围内医疗器械的定义在指令中作了明确的规定，有些产品看似医疗器械，如一些按摩器，口罩等。实际上并不在医疗器械指令范围的。
二、确认适用的基本要求指令规定，任何医疗器械必须满足指令附录Ⅰ中所规定的预期用途，所以对制造商来说，首先要做的而且最重要的事情就是确认所有的适用于其产品的基本条件。
三、确认任何有关的欧洲协调标准协调标准是由欧洲标准委员会（CEN）和欧洲电气技术委员会（CENELEC）制定的公布在欧盟官方杂志上的标准，对于某种医疗器械来说，可能有多种协调标准适用于它。因此在确认哪些协调标准适用于它。因此在确认哪些协调标准适用于某种产品时应十分仔细。
四、确保产品满足基本要求或协调标准的要求并且使证据文件化·制造商应能提出充分的证据（如由公告机构或其他检测机构依据协调标准进行的检测等）来证明产品符合基本要求。
五、产品分类根据指令附录Ⅸ的分类规则，医疗器械分成4类．即ⅠⅡA、ⅡB&.127；和Ⅲ类，不同类型的产品、其获得CE标志的途径（符合性评价程序）不同，因此对制造商来说，如何准确地确定其产品的类型，是十分关键的。
六、确定相应的符合性评价程序对于Ⅱa、ⅡbⅢ类医疗器械的制造商来说，存在着如何选择符合评价程序途径的问题。主要的区别是选择型式试验的方式，还是选择质量体系的方式，这两种途径各有其特点。制造商应根据自己的实际情况选择最为适合的途径。
七、选择公告机构对于Ⅱa、Ⅱb和Ⅲ类医疗器械，以及无菌的或具有测量功能的I类医疗器械，应选择一个公告机构并进行符合性评价程序。在欧盟官方杂志上公告的公告机构名单上，对每个公告机构可以从事的医疗器械认证以及可进行的符合性评价程序途径都有严格的规定，制造商在选择公告机构时，必须非常谨慎，避免造成不必要的损失。
八、起草符合性声明并加贴CE标志可以说符合性声明是重要的文件。每一种器械必须包括医疗器械指令的附录中所描述的符合性声明。
医疗器械CE证书的分类
目前有如下几种类型的CE证书：
(1)Declaration of conformity / Declaration of compliance《符合性声明书》，此证书属于自我声明书，不应由第三方机构中介或测试认证机构签发，因此，可以用欧盟格式的企业《符合性声明书》代替。
(2)Certificate of compliance / Certificate of compliance《符合性证书》，此为第三方机构=(中介或测试认证机构)颁发的符合性声明，必须附有测试报告等技术资料TCF，如果没有测试报告也可交由第三方机构办理。同时，企业也要签署《符合性声明书》。
(3)EC Attestation of conformity 《欧盟标准符合性证明书》，此为欧盟公告机构(Notified Body简写为NB)颁发的证书，按照欧盟法规，只有NB才有资格颁发EC Type的CEE声明，此证书可用作清关，为一次性证书。
医疗器械产品做CE认证并可以发欧洲NB证书的机构由哪些？
Notifying Authority | Found : 35 | | 93/42/EEC Medical devices |  Australia | Department of Health and Ageing (MRA) |  Austria | Bundesministerium für Gesundheit - Department Pharmaceuticals and Medical Devices - III/3 |  Belgium | Agence Fédérale des Médicaments et des Produits de Santé (AFMPS) - Federaal Agentschap voor Geneesmiddelen en Gezondheidsproducten (FAGG) |  Bulgaria | State Agency for Metrological and Technical Surveillance |  Canada | Health Canada (MRA) |  Croatia | Ministry of Health |  Cyprus | Ministry of Energy, Commerce, Industry and Tourism |  Czech Republic | Czech Institute for Standardization, Metrology and Testing - Department of Testing |  Denmark | L?gemiddelstyrelsen / Danish Medicines Agency |  Estonia | Internal Market Department Ministry of Economic Affairs and Communications of Estonia |  Finland | Ministry of Employment and the Economy | | France | Agence Fran?aise de Sécurité Sanitaire des Produits de Santé - Direction de l'Evaluation des Dispositifs Médicaux | | Germany | Zentralstelle der L?nder für Gesundheitsschutz bei Arzneimitteln und Medizinprodukten (ZLG) | | Greece | National Organization for Medicines (EOF) | | Hungary | Office of Health Authorisation and Administrative Procedures | | Iceland | Ministry of Welfare (Velferearráeuneytie) | | Ireland | Irish Medicines Board (IMB) | | Italy | Ministero dello Sviluppo Economico - Direzione Generale per il Mercato, la Concorrenza, il Consumatore, la Vigilanza e la Normativa Tecnica | | Latvia | Ministry of Economics, Internal Market Department | | Lithuania | Ministry of Economy, Internal Market Co-ordination Department | | Luxembourg | OLAS - Office Luxembourgeois d’Accréditation et de Surveillance | | Malta | Malta Competition and Consumer Affairs Authority - Technical Regulations Division | | Netherlands | VWS/ directie GMT | | New Zealand | Testing Laboratory Registration Council (MRA) | | Norway | Norwegian Ministry of Health and Care Services | | Poland | Ministry of Economy - Innovation and Industrial Department | | Portugal | INFARMED - Autoridade Nacional do Medicamento e Produtos de Saúde, I.P. | | Romania | Ministry of Public Health | | Slovakia | Slovak Office of Standards, Metrology and Testing | | Slovenia | Ministry of the Economy | | Spain | Agencia Espa?ola de Medicamentos y Productos Sanitarios | | Sweden | SWEDAC - Swedish Board for Accreditation and Conformity Assessment | | Switzerland | State Secretariat for Economic Affairs (SECO) - Federal Department of Economic Affairs FDEA (MRA) | | Turkey | Ministry of Economy – DG Product Safety and Inspection | | United Kingdom | Department of Health Medicines and Healthcare products Regulatory Agency
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Official website: http://ec./enterprise/newapproach/nando/index.cfm?fuseaction=na.main
医疗器械产品做CE认证，是否需要公告机构？Need for notified body?
Before proceeding with the assessment procedure, it is important to establish whether you, the manufacturer, can assess your product by yourself or whether you have to involve a Notified Body.
In the Directive on Medical Devices, the medical device is classified in accordance with the provisions of Annex IX of the MDD as class I (low risk), class IIa or IIb (medium risk) or class III (high risk). The involvement of a Notified Body is not necessary for medical devices of class I unless they have a measuring function or are placed on the market in a sterile condition.
A Notified Body verifies in most of the cases only the quality management of the manufacturer. For all medical devices belonging to class III, and for medical devices belonging to class IIa and IIb on a representative basis, the design of the medical device and its compliance with the Essential Requirements must be examined by a Notified Body. The Notified Body issues a certificate that indicates, by referring to one of the Annexes II to VI of the MDD, what has been verified.
To find the Notified Bodies appointed by the Member States to carry out conformity assessment, please consult NANDO – the New Approach Notified and Designated Organisations database. You can search for Notified Bodies by Directive, country or by the Notified Body's number (indicated next to the CE marking) via the NANDO homepage.
III. CLASSIFICATION
class I (low risk) 、class IIa or IIb (medium risk)、class III (high risk)
1 . Non-invasive devices
1.1 . Rule 1
All non-invasive devices are in Class I, unless one of the rules set out hereinafter applies .
1.2 . Rule 2
All non-invasive devices intended for channelling or storing blood, body liquids or tissues , liquids or gases for the purpose of eventual infusion, administration or introduction into the body are in Class Ila:
— if they may be connected to an active medical device in Class Ila or a higher class ,
— if they are intended for use for storing or channelling blood or other body liquids or for storing organs, parts of organs or body tissues , in all other cases they are in Class I.
1.3 . Rule 3
All non-invasive devices intended for modifying the biological or chemical composition of blood, other body liquids or other liquids intended for infusion into the body are in Class lib, unless the treatment consists of filtration, centrifugation or exchanges of gas , heat, in which case they are in Class Ila.
1.4 . Rule 4
All non-invasive devices which come into contact with injured skin:
— are in Class I if they are intended to be used as a mechanical barrier, for compression or for absorption of exudates,
— are in Class lib if they are intended to be used principally with wounds which have breached the dermis and can only heal by secondary intent,
— are in Class Ha in all other cases, including devices principally intended to manage the micro-environment of a wound
Annex IX http://eur-lex./legal-content/EN/TXT/PDF/?uri=CELEX:31993L0042&from=EN |
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