Medical Device Technical File and Design Dossier

Medical Device Technical File Contents and Language

It is recommend to submit the Technical file in English by applicants from non-European countries. For applicants from European countries can submit in its official language but should not do so if the national authorities can understand the file or its contents in the other language. Where a translation is required the person in possession of the file will be allowed extra time to submit the first part of the Technical file to the inspection authorities.

Who should maintain Technical File

The Technical File must be kept at the disposal of the authorities for inspection purposes. A copy should be maintained as per QMS requirement.  In case the manufacturer is outside European union a copy of the Technical file should be made available with European representative in the Community.

If the manufacturer is not established in the Community and has no representative in the Community, the person who places the product on the European Community market must take on this obligation.

Any person responsible for marketing medical device in the region must know the technical file details such as document ID, Issue and revision number with latest edition.

However, the name and address of the person in possession of the Technical file need not be expressly mentioned on the product or on its packaging, unless otherwise specified.

The Technical file cannot be requested without any reason, only during checks made by Notified Body. In general the manufacturer or person responsible for placing a medical device product on the Community market should initially provide the inspection authorities with only a summary of the essential technical data (part A of the technical file).The full file can only reasonably be requested where necessary and certainly not when only an individual point is to be checked, in which case only the relevant part of the file should be required. If the competent authorities in the Member State request the technical file, the first part of the technical file (part A) should be made available immediately, followed by Part B with the latest issue number and revision number.
The technical file must be kept for at least Six years from the last date of manufacture of the product, unless the directive expressly provides for any other duration.

Role of I3C team in the development (MDR) Medical Device Technical File

Additional Resources

  • Cost of EU MDR Technical File Preparation.
  • EU MDR Technical File Contents and Language.
  • Cost of Clinical Evaluation Documentation.
  • CE Marking Technical File Contents.
  • Role of Consultant and Client.
  • Request for Quote for CE Marking Technical File.(Online Form).
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