所有進入歐盟市場的醫(yī)療器械都必須進行醫(yī)療器械CE認(rèn)證，醫(yī)療器械需要滿足的CE指令有Active Implantable Medical Devices《有源植入性醫(yī)療器械指令》(AIMDD, 90/385/EEC),、Medical devices《醫(yī)療器械指令》(MDD,93/42/EEC)和In vitro diagnostic medical devices體外診斷器械指令(IVDD, 98/79/EC),。
歐洲醫(yī)療產(chǎn)品CE認(rèn)證指令如下： Active implantable medical devices
In vitro diagnostic medical devices
Medical devices (MDD)
醫(yī)療器械怎樣取得“CE認(rèn)證標(biāo)志”
以下以取得CE認(rèn)證為例說明：
產(chǎn)品要順利通過CE認(rèn)證，需要做好三方面的工作,。
第一,，收集與認(rèn)證產(chǎn)品有關(guān)的歐盟技術(shù)法規(guī)和歐盟（EN）標(biāo)準(zhǔn),，通過消化、吸收,、納入企業(yè)產(chǎn)品標(biāo)準(zhǔn),。
第二，企業(yè)嚴(yán)格按照以上產(chǎn)品標(biāo)準(zhǔn)組織生產(chǎn),，也就是把上述技術(shù)法規(guī)和EN標(biāo)準(zhǔn)的要求,，貫徹到企業(yè)產(chǎn)品的設(shè)計開發(fā)和生產(chǎn)制造的全過程。
第三,，企業(yè)必須按照ISO9000 ISO13485標(biāo)準(zhǔn)建和維護質(zhì)量體系,，并取得ISO9000 ISO13485認(rèn)證。
獲得CE標(biāo)志的一般程序
目前國內(nèi)的一些醫(yī)療器械廠家（特別是一些鄉(xiāng)鎮(zhèn)企業(yè)）對醫(yī)療器械指令不甚了解,，不知如何著手申請CE標(biāo)志,。為此我們簡單地介紹獲得CE標(biāo)志所需步驟如下：
一、分析器械及特點,，確定它是否在指令的范圍內(nèi)醫(yī)療器械的定義在指令中作了明確的規(guī)定,，有些產(chǎn)品看似醫(yī)療器械，如一些按摩器,，口罩等,。實際上并不在醫(yī)療器械指令范圍的。
二,、確認(rèn)適用的基本要求指令規(guī)定,，任何醫(yī)療器械必須滿足指令附錄Ⅰ中所規(guī)定的預(yù)期用途，所以對制造商來說,，首先要做的而且最重要的事情就是確認(rèn)所有的適用于其產(chǎn)品的基本條件,。
三、確認(rèn)任何有關(guān)的歐洲協(xié)調(diào)標(biāo)準(zhǔn)協(xié)調(diào)標(biāo)準(zhǔn)是由歐洲標(biāo)準(zhǔn)委員會（CEN）和歐洲電氣技術(shù)委員會（CENELEC）制定的公布在歐盟官方雜志上的標(biāo)準(zhǔn),，對于某種醫(yī)療器械來說,，可能有多種協(xié)調(diào)標(biāo)準(zhǔn)適用于它。因此在確認(rèn)哪些協(xié)調(diào)標(biāo)準(zhǔn)適用于它,。因此在確認(rèn)哪些協(xié)調(diào)標(biāo)準(zhǔn)適用于某種產(chǎn)品時應(yīng)十分仔細(xì),。
四、確保產(chǎn)品滿足基本要求或協(xié)調(diào)標(biāo)準(zhǔn)的要求并且使證據(jù)文件化·制造商應(yīng)能提出充分的證據(jù)（如由公告機構(gòu)或其他檢測機構(gòu)依據(jù)協(xié)調(diào)標(biāo)準(zhǔn)進行的檢測等）來證明產(chǎn)品符合基本要求,。
五,、產(chǎn)品分類根據(jù)指令附錄Ⅸ的分類規(guī)則，醫(yī)療器械分成4類．即ⅠⅡA,、ⅡB&.127,；和Ⅲ類，不同類型的產(chǎn)品,、其獲得CE標(biāo)志的途徑（符合性評價程序）不同,，因此對制造商來說,，如何準(zhǔn)確地確定其產(chǎn)品的類型，是十分關(guān)鍵的,。
六,、確定相應(yīng)的符合性評價程序?qū)τ冖騛、ⅡbⅢ類醫(yī)療器械的制造商來說,，存在著如何選擇符合評價程序途徑的問題,。主要的區(qū)別是選擇型式試驗的方式，還是選擇質(zhì)量體系的方式,，這兩種途徑各有其特點,。制造商應(yīng)根據(jù)自己的實際情況選擇最為適合的途徑。
七,、選擇公告機構(gòu)對于Ⅱa,、Ⅱb和Ⅲ類醫(yī)療器械，以及無菌的或具有測量功能的I類醫(yī)療器械,，應(yīng)選擇一個公告機構(gòu)并進行符合性評價程序。在歐盟官方雜志上公告的公告機構(gòu)名單上,，對每個公告機構(gòu)可以從事的醫(yī)療器械認(rèn)證以及可進行的符合性評價程序途徑都有嚴(yán)格的規(guī)定,，制造商在選擇公告機構(gòu)時，必須非常謹(jǐn)慎,，避免造成不必要的損失,。
八、起草符合性聲明并加貼CE標(biāo)志可以說符合性聲明是重要的文件,。每一種器械必須包括醫(yī)療器械指令的附錄中所描述的符合性聲明,。
醫(yī)療器械CE證書的分類
目前有如下幾種類型的CE證書：
(1)Declaration of conformity / Declaration of compliance《符合性聲明書》，此證書屬于自我聲明書,，不應(yīng)由第三方機構(gòu)中介或測試認(rèn)證機構(gòu)簽發(fā),，因此，可以用歐盟格式的企業(yè)《符合性聲明書》代替,。
(2)Certificate of compliance / Certificate of compliance《符合性證書》,，此為第三方機構(gòu)=(中介或測試認(rèn)證機構(gòu))頒發(fā)的符合性聲明，必須附有測試報告等技術(shù)資料TCF,，如果沒有測試報告也可交由第三方機構(gòu)辦理,。同時，企業(yè)也要簽署《符合性聲明書》,。
(3)EC Attestation of conformity 《歐盟標(biāo)準(zhǔn)符合性證明書》,，此為歐盟公告機構(gòu)(Notified Body簡寫為NB)頒發(fā)的證書，按照歐盟法規(guī),，只有NB才有資格頒發(fā)EC Type的CEE聲明,，此證書可用作清關(guān),，為一次性證書。
醫(yī)療器械產(chǎn)品做CE認(rèn)證并可以發(fā)歐洲NB證書的機構(gòu)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
醫(yī)療器械產(chǎn)品做CE認(rèn)證,，是否需要公告機構(gòu)？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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