Technical File




Technical File for Medical Device


Technical File for medical device is a must for all type of devices regardless of the risk classification. Manufacturers are advised to start working on revising the CE Marking regardless of Notified Body.

New European medical device regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) the CE Certificate will be issued by Notified Body after a thorough review of Technical File Documentation.

The Technical File must be prepared and submitted to notified body by the manufacturer.

The new (EU MDR 2017/745) Medical Devices Regulation and (IVDR 2017/746) In Vitro Diagnostic Regulation has a lot of additional requirements compared to medical device directive which is explained below.

I3 Consulting has gained sufficient knowledge via training, Internal debate, Conferences about actual contents of file and displacement. In short, our team is sufficiently educated to assist and guide with the MDR transition.

Stringent Technical Documentation requirement in MDR

According to the new Medical Device Regulation, annex II identifies forty-seven specific requirements about the content of the primary technical documentation and fifteen additional requirements from annex III on Post Market Surveillance.

Article 10 describes the obligation of manufacturers what is needed and why it is needed in the Medical Device Regulation Technical Documentation. Article 15 insists for an experienced regulatory person and his role in updating the Technical Documentation anytime for Notified Body assessment.

The MDD’s Design Dossier concept has been removed from the new EU MDR.

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

  • Review existing documentation in support of meeting the applicable MDR Essential Requirements.
  • Study the device, Identify and evaluate gaps or deficiencies in your new EU MDR.
  • Determine applicable testing requirements and standards for your device after a Risk Analysis.
  • Organize Clinical Evidence in the form of Clinical Evaluation Report (CER).
  • Preparation of Post Market Surveillance Report (PMS), and derive the conclusion of CER.
  • Preparation of Post Market Clinical Follow Up Report (PMCF), and derive conclusion of CER.
  • Review your specimen labeling and Instructions for Use (IFU)and User Manual.
  • Compile Pre-Clinical Verification and Validation documentation.

Consultants role in successfull submission of MDR Tech Files

We can deliver structured solutions for developing high-quality Technical Documentation for any risk class starting from drafting the File, reviewing and modifying the contents, support in filling the Gaps, submitting to Notified Body of your choice and also coordinate with Notified bodies till documentation is approved.


Based on the following criteria the number of tech files to be decided by the manufacturer as per new MDR.

  • Risk Class of the device
  • Intended use
  • Construction Material
  • Site of application
  • State of Art in technology
  • Clinical benefits

Yes, you can apply with multiple notified Bodies. But you cannot apply for the same device already CE Certified or to be CE Certified.



Recent Client Testimonial:


Technical File Reviewed by Mr. Steve in . Wonderful Guidance & Services by I 3 Consulting Team. highly recommended for those who are looking for Tech Files services. Rating: 4.9

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