Technical File

All CE marking directives require a Technical File which should contain the information required to establish that the product complies with the requirements of the particular directive which you are planning for CE Certificating. The technical file shall be compiled by the manufacturer or authorized representative.

Most of the new approach directives impose an obligation for the manufacturer to draw up and to provide technical documentation containing actual information to demonstrate the conformity of the product to the MDD, IVD or AIMD directives.

Although Medical Device Directive hints out the content of the technical file without much explanation, the reason is, technical documentation always depends on the nature of the product and on what is necessary, from the technical point of view, to demonstrate the conformity of the product either to the harmonized standards, if the manufacturer has followed them, or to the essential requirements of the relevant directive if the manufacturer has followed none or only some of the harmonized standards. This must, therefore, be determined case by case depending on the product.

Technical File Contents
There is nothing wrong, the Technical File contains more information than those listed above. However, these should not be used to pack the file at the expense of the more relevant information on how the equipment operates missing or how the safety objectives of the Directives established.

The most important Technical File Contents are the following

  • Medical Device information.
  • Design and approvals
  • Declaration of Conformity (DOC)
  • Vigilance Control.
  • European  Authorized Representative agreement
  • Essential Requirements.
  • List of Harmonized Standards.
  • Clinical evaluations.
  • Risk Management.
  • IFU/Manual/Labelling

If you need to purchase detailed Technical File Contents (table of contents) separately for (a) Software Medical Device (b) Active Medical Device (c) Non Active Medical Device (d) Implantable Medical Device (e) In-vitro Diagnostic Medical Device please contact us via mail.

Refer Technical File table of contents here.

If you need complete help in the preparation of Technical File onsite or offsite please check the fees here.

Technical File Vs Design Dossier
A design dossier is an expanded technical file which has to be pre-submitted to the notified body for class 111 medical devices.

Use CE Expert
How fast we can achieve CE Certification depends on the quality of the Technical File. It is important to note the consultant can be away from you, no matter where he or she sits.  We are technical experts with hands on experience in various devices, serving clients across the globe. Contact us is very easy!!!
Here the links – Click here   
You can also check the technical file preparation fees here

Who should maintain Technical File
Language of the Technical File
Responsibility sharing matrix (Consultant Vs. Client)

INDIA – Bangalore
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