Medical Device Technical File and Design Dossier

Medical Device Technical File

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 Documentation. The 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 requirments compaired to MDD which is exlained below. I 3 CONSULING has gained sufficient knowledge via trainings, Internal debate, Conferences about actual contents of file and desplacement. In short our team is sufficiently educated to assist and guide with the MDR transition.

Technical File Documentation

According to 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 MDR Technical Documentation. Article 15 insists for an experienced regulatory person and his role in updating the Technical Documentation anytime for Notified Body assessment.

It is to be noted that CE Marking Technical File is a must for all type of devices regardless of the risk classification. Manufacturers are advised to start working on revising the CE Marking Technical file regardless of Notified Body.

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

While preparing a CE Marking Technical 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 Technical File.
  • Determine applicable testing requirements and standards for your device after a Risk Analysis.
  • Organize Clinical Evidences in the form of Clinical Evaluation Report (CER).
  • Preparation of Post Market Surveillance Report (PMS), and derive 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.

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

We can deliver structured solutions for developing high quality Medical Device 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.

Additional Resources

  • Cost of EU MDR Technical File Preparation.
  • 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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