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Get PriceDraw up the EU Declaration of Conformity when the Technical File is complete Keep a copy of the declaration in the Technical File More information Understanding European Declarations of Conformity or Incorporation Technical File Amazon requirements for uploading a Declaration of Conformity and the Responsible Person for CE Marked Products
Get PriceThe technical documentation may need to be reviewed by a Notified Body NB before a CE marking certificate can be issued depending on the IVD classification and conformity assessment route Once completed the technical file must be made available to European Competent Authorities upon request IVDR Technical File Requirements
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Get PriceYour Notified Body would issue an MDD CE certificate valid for five MDR essentially forces an automatic review of one or more of your technical documentation files during every surveillance audit This means that under the EU MDR your device is approved for up to five years but not automatically approved for a five year term as
Get PriceThe Technical Construction File defines the product design and the conditions for safe usage The file contains information such as drawings certificates test reports calculations the user manual part lists etc The Technical File is kept by the manufacturer which keeps it available for competent national authorities
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Get PriceThe working group of Notified Bodies has issued recommendations for the structure of the technical file in the guidance NB MED// Technical Documentation The technical file should in any case be available in an official language of an EU member state and available on request for the whole product life cycle but at least for a period of 5 years from the production of the
Get PriceThe technical file acts as a record that the manufacturer has properly identified the applicable CE directives and carried out the necessary conformity assessment procedures to verify compliance This is particularly important if liability claims or recalls are made and the manufacturer importer or distributor is held accountable
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Get PriceTechnical files EU Introduction To comply with European legislation around product compliance you need to be able to provide evidence stored in a so called Technical file You can create your own Technical file within the ProductIP platform The process of making a Technical file can be divided in a couple of steps Summary
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Get PriceMay 28 2021Ensuring the availability of technical files and conformity documentation Cooperating with market surveillance authorities Informing authorities when there is reason to believe that a product presents a risk The responsible party can be the manufacturer importer distributor fulfillment service provider or authorised representative
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