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Guidance documents for CE marking

In order to save time for our customers, we have created series of PC files to help them to build their Technical files.We give them free of charge.

These main documents are:

  • Checklist of the documents with shall be included in the full Technical file
  • Checklist of the documents that we need to keep in our European office for allowing us to make the notification/registration and to present to Competent Authorities upon request
  • Essential Requirements list. The manufacturer has to answer with reference to standards and to the titles of their internal procedures
  • Risk Analysis. Manufacturers have to show that they have minimize the potential risks for patients and users, and that the remaining risks are low compared to the product benefits.
  • Symbols for multilingual labeling
  • Frameworks to answer to the chosen annexes of the MD and IVD Directives
  • Models of CE declarations

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