Medical Device Technical File / Design Dossier

As per new Medical Device Regulation (MDR) and Medical Device Directive (MDD)

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 EU 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 requirments of 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 or Class III Design Dossier so we can assist with the MDR Technical File transition process smoothly.

Medical Device Technical File / Design Dossier Contents as per Medical Device Regulation(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 as per MDR.
  • Study the device, Identify and evaluate gaps or deficiencies in your MDR Technical File and Dessign Dossier.
  • 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 Medical Device Technical File & MDR 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

Our team of equipped with Lead Auditors, Consultants, and Medical Writers for new MDR Technical File support.

How fast we can achieve CE Certification depends on the quality of the Technical File prepared as per Medical Device Regulation (MDR) requirments.  It is important to note the consultant can be away from you, so, no matter where he or she sits.  We are technical experts with hands on experience in various devices, serving clients across the globe.

When you read through the Technical File / Design Dossier table of contents, you may be confused in what way I 3 CONSULTING can be helpful to your company. You are advised to read responsibility sharing matrix between client and Consultant (read >>)


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