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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,
10、 manufacturing and final inspection) according to Annex II, except for Section 4.Alternative 2:The manufacturer himself declares that the products meet the provisions of the Directive which apply to them according to Annex VII. In addition the Notified Body examines and accepts each manufactured ite
11、m/batch according to Annex IV or accepts the quality system for production and final testing according to Annex V or the quality system for products according to Annex VI.After having taken various administrative measures described in the relevant Annex, the manufacturer then affix the CE mark and t
12、he identification number of the Notified Body to the product.Class IIaDevice Article 11:2Either OrAnnex IIA system with full quality assuranceAnnex VIIDeclaration of conformity With Annex VA system with production quality assuranceAnnex VIA system with product quality assuranceAnnex IVEC verificatio
13、n-Evalutation and testing of every device or statistical verification Either Or Or Not including exam of the design (Article II, clause 3a) CECECECEClass IIb productsAlternative 1:The Notified Body shall accept the manufacturers total quality system (design, manufacturing and final inspection) accor
14、ding to Annex II, except for Section 4.Alternative 2:The Notified Body shall examine and assess the documentation and type-test the product according to Annex III and examine and accept each manufactured item/batch according to Annex IV or accept the quality system for production and final testing a
15、ccording to Annex V or the quality system for products according to Annex VI.After having taken various administrative measures described in the relevant Annex, the manufacturer then affix the CE mark and the identification number of the Notified Body to the product.Class IIbDevice Article 11:3Eithe
16、r OrAnnex IIA system with full quality assurance systemAnnex IIIType examination With Annex VIA system with product quality assuranceAnnex VA system with production quality assuranceAnnex IVEC verification-Evalutation and testing of every device or statistical verification Either Or Or Not including
17、 exam of the design (Article II, clause 3a) CECECECEClass III productsAlternative 1:The Notified Body shall accept the manufacturers total quality system (design, manufacturing and final inspection) and examine the design of the product according to Annex II.Alternative 2:The Notified Body shall exa
18、mine and assess the documentation and type-test the product according to Annex III and examine and accept each manufactured item/batch according to Annex IV or accept the quality system for production and final testing according to Annex V.After having taken various administrative measures described
19、 in the relevant Annex, the manufacturer then affix the CE mark and the identification number of the Notified Body to the product.Class IIIDevice Either OrAnnex IIA system with full quality assurance system including examination of the designAnnex IIIType examination With Or Or Annex VA system with production quality assuranceAnnex IVEC verification-Evalutation and testing of every device or statistical verification CECECE