Technical File

Technical File for Medical Device (MDR)

Technical Documentation so called Technical File for Medical Device is a comprehensive file covering complete information to demonstrate safety and performance of the device against the manufactures claimed intended use. The information given in the Technical Files are structured as per MDR and IVDR requirements suitably to address General Safety and Performance Requirements (GSPR).

Notified body will audit technical files on annual basis to assess compliance with general safety and performance requirements. The Technical File should be developed for all type of device risk class. ( I, Is, Im, Ir, IIa, IIb, III).

Latest version of Technical Files must be retained either in electronic or hardcopy form at manufacturer premises or authorized representative premise for potential request from a EU competent authorities or from Notified Body. During initial phase of CE Marking application, complete technical documentation must submit to the notified body. After closing all review comments and updating the technical file, the notified body issues CE Certificate.

As all are aware the change in regulation from MDD / IVD to MDR / IVDR, all manufacturers need to update their technical documentation. We are medical device regulatory consultants provide MDR / IVDR remediation service. MedDeviceCorp team has gained sufficient knowledge in MDR/IVDR via training, internal debate, conferences, workshops and live upgradation services.

Stringent Technical File Documentation requirement in MDR

According to the new Medical Device Regulation, annex II identifies forty-seven specific requirements about the content of the primary file 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 the conclusion of CER.
  • Review your specimen labeling and Instructions for Use (IFU)and User Manual.
  • Compile Pre-Clinical Verification and Validation documentation.

MDR Technical File Contents >>>

IVDR Technical File Contents >>>

Consultants role in successful submission of MDR

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.

If you are finding ways to update a legacy medical device technical file to meet new medical device regulation, we at MedDeviceCorp help with Medical Device Technical File remediation service. We start our guidance and preparation after through understanding of your subject device to identify disparities between your medical device and present technical file / requirements. Unlike others we do not allow the client team to work on the technical file till successful completion of the CE Certification project.

Know Client and Consultant responsibility in the development of Technical File >>>

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

  • Risk Class of the device
  • Intended use
  • Construction Material
  • Site of application
  • The 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.

Minimum for five years from the last date of manufacture of the product. In case of Implantable devices it is for 15 years.

Recent Client Testimonial:

Mr. Steven Mclaren Reviewed and commented in . "Wonderful Guidance & Services by MedDeviceCorp", highly recommended for those who are looking for Technical File submissions. Rating: 4.9

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Recent Client Testimonial:

Mr. Steven Mclaren Reviewed and commented in . "Wonderful Guidance & Services by MedDeviceCorp", highly recommended for those who are looking for Technical File submissions. Rating: 4.9