Medical Device Technical File and Design Dossier

The CE Certificate will be issued by Notified Body after a thorough review of technical documentation so called Technical File or Design Dossier. The Technical File shall be prepared by the manufacturer and submitted to Notified Body.

The new MDR 2017/745 Medical Devices Regulation and IVDR 2017/746 In Vitro Diagnostic Regulation has a lot to work with the Technical File preparation to satisfy the Notified body of your choice. I 3 CONSULING already gained sufficient knowledge of what is to be added, what not to be in the Technical File/Design Dossier so we can assist with the MDR/IVDR transition process smoothly.

Medical Device Technical File / Design Dossier Contents as per MDR
Although regulations mention out the content of the technical file without much explanation, the reason is technical documentation always depends on the intended use, mechanism of action, sterility, construction material etc.  However, this information should not be used to pack the Technical File at the expense of the more relevant information on how the equipment operates missing or how the safety objectives of the Directives established.

While preparing a Technical File you should have sound knowledge technically to present information on the correct way, some of the core areas are the following.

  • To review all existing documentation in support of meeting the applicable Essential Requirements MDR
  • Study the device, Identify and evaluate gaps or deficiencies in your TF/DD
  • Determine applicable testing requirements and standards for your device after a risk evaluation
  • Preparation of Clinical Evaluation Report (CER), and facilitate a Risk Assessment if necessary
  • Review your specimen labeling and Instructions for Use (IFU)and User Manual.
  • Compile Technical File or Design Dossier after internal peer review

Readers can obtain information by visiting other pages of the website for Technical File /Design Dossier Contents as per MDR (read>>) and approximate pricing for Technical File / Design Dossier (read>>) for the budgetary purpose.

Difference between a Technical File and 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

A team of Lead Auditors, Consultants and Medical Writers from I 3 CONSULTING

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!!!
When you read though the Technical File / Design Dossier table of contents, you may be confused what way I 3 CONSULTING going to helpful for us. You are advised to Responsibility Sharing Matrix between client and Consultant (read >>)

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