The roads to CE marking of medical devices
For manufacturers of devices covered by the
Medical Device Directive 93/42/EEC
General requirements
All manufacturers of medical devices must:
(custom-made devices and devices intended for clinical investigation are excluded)阿根廷红虾
classify the devices (Annex IX)
bad upon the class the device belongs to, lect (Article 11) and follow the appropriate conformity asssment procedure (Annexes II - VII). (See summaries for each class below.) 白百合图片The harmonid standard to fulfil the requirements of the quality systems in Annexes II, V and VI is EN ISO 13485:2003 “Medical Devices – Quality systems – Requirements for regulatory purpos” where applicable.鲁迅介绍>战斧摩托
ensure that the devices fulfil the Esntial 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 risk analysis, a list of standards applied, test reports etc. The documentation shall make it possible to asss the conformity of the product with the requirements of the Directive
establish a system for reviewing data about products placed on the market and implement appropriate means to apply any necessary corrective actions
notify the authorities of rious accidents and narrow escapes caud by the product
issue an EC Declaration of Conformity
file the EC Declaration of Conformity, the technical documentation, as well as decisions, reports and certificates from Notified Bodies to make them available to th
e national authorities (shall be filed for a period ending at least five years after the last product has been manufactured)
All products must
comply with the Esntial Requirements
be provided with CE marking, except for custom made devices and devices intended for clinical investigations
Class I products
The manufacturer himlf 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 reprentative for marketing of the product shall register 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女人梦见掉牙 has a measuring function. The Notified Body shall examine the production process with regard to sterility and/or measuring function (Annexes IV, V or VI).
Class I
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Article 11:5
YES NO
*) Limited u
Class IIa products
Alternative 1:
The Notified Body shall accept the manufacturer's total quality system (design, manufacturing and final inspection) according to Annex II, except for Section 4.
Alternative 2:
The manufacturer himlf 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 item/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 the identification number of the Notified Body to the product.
Class IIa
Article 11:2
Either Or
With
Either Or Or
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Not including
exam of the design
(Article II, clau 3a)
Class IIb products
Alternative 1:
