医疗器械ce认证的途径i iia iib iii 所有类别(intertek 官方版).doc
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1、The roads to CE marking of medical devicesFor manufacturers of devices covered by the Medical Device Directive 93/42/EECGeneral requirementsAll manufacturers of medical devices must:(custom-made devices and devices intended for clinical investigation are excluded)classify the devices (Annex IX)based
2、 upon the class the device belongs to, select (Article 11) and follow the appropriate conformity assessment procedure (Annexes II - VII). (See summaries for each class below.) The harmonised standard to fulfil the requirements of the quality systems in Annexes II, V and VI is EN ISO 13485:2003 “Medi
3、cal Devices Quality systems Requirements for regulatory purposes” where applicable.ensure that the devices fulfil the Essential Requirements (Annex I) prepare technical documentation (Annex II, III or VII) which shall include a general description of the product, design drawings, the results of the
4、risk analysis, a list of standards applied, test reports etc. The documentation shall make it possible to assess the conformity of the product with the requirements of the Directiveestablish a system for reviewing data about products placed on the market and implement appropriate means to apply any
5、necessary corrective actionsnotify the authorities of serious accidents and narrow escapes caused by the productissue an EC Declaration of Conformityfile the EC Declaration of Conformity, the technical documentation, as well as decisions, reports and certificates from Notified Bodies to make them av
6、ailable to the national authorities (shall be filed for a period ending at least five years after the last product has been manufactured)All products mustcomply with the Essential Requirementsbe provided with CE marking, except for custom made devices and devices intended for clinical investigations
7、Class I productsThe manufacturer himself declares that the products meet the provisions of the Directive which apply to them, prepares a technical documentation and affix the CE mark to the device (Annex VII).The manufacturer or his authorized representative for marketing of the product shall regist
8、er his activities at the competent authority of the member state where his registered business is located.Exception:The device is placed on the market in a sterile condition and/or has a measuring function. The Notified Body shall examine the production process with regard to sterility and/or measur
9、ing function (Annexes IV, V or VI).Class IDevice Article 11:5 Annex VIIDeclaration of conformity Sterile or measuring YES NO *Annex IV, V or VIVerification of Notified BodyCECE*) Limited useClass IIa productsAlternative 1:The Notified Body shall accept the manufacturers total quality system (design,
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