Do You Know What Your Tech File Should Include?

by | Feb 22, 2019 | EU, EU MDR, FDA, Medical Devices, Quality Systems, Regulatory

With the new EU MDR, companies must comply with several new requirements. Our previous blogs gave a snapshot of what has changed in the new EU MDR and how as a Medical Device manufacturer you can best deal with these changes. You can read some of our EU MDR blogs here:

INTRODUCTION TO CLINICAL EVALUATION REPORTS (CERS),

TRANSITIONING TO THE EU MDR? DO YOU HAVE A PRRC YET?

WHAT THE NEW EU MDR MEANS TO YOUR REVENUE

Technical documentation, according to the new EU MDR, should summarize your entire device including its design, verification, validation, your post-market surveillance plan and any clinical or pre-clinical studies that were conducted. The technical file is reviewed by the Notified body and hence it should contain all the technical documents as well as the relevant quality system data for the NB’s review.

One thing to keep in mind while compiling the technical file would be the extent and the detail by which the NB will review the file.

Let’s look at the revised contents of the technical file under the new EU MDR:1

  • Addition of the UDI information of your device in the device description and specification section is now required
  • According to the General Safety and Performance Requirements of the technical document, manufacturers of single-use devices (SUD) will have to document their rationale for designing the device as a SUD in their risk management file
  • The new MDR has updated the classification risk levels, therefore the technical documents will require an update to the classification of the device along with it a justification for the classification applied for the device
  • Referencing previous generations of devices to facilitate post-market surveillance
  • Excerpts of your quality system will also have to be included in the technical file, which includes a description of the design stages and the procedures applicable to the device. However, this is only required for a Class III devices. Due to the change in the classification system, manufacturers should check for their device classification and the content of the technical file.
  • Competent authorities can request for the technical document to be provided in an official EU language if the information could not be comprehended from its original language.
  • It was previously not required to include a post-market clinical follow-up plan in the technical fil; however, in the new MDR, there is an emphasis on clinical data. Thus, a post-market clinical follow-up needs to be presented to assure that the clinical data is continuously monitored.
  • A separate section that addresses the post-market surveillance plan to gather information from the users on their devices is also required. The technical file needs to be updated depending on the data collected from the implementation of this plan.

In conclusion, the technical file under the new EU MDR will require new updates periodically depending on the post-market data. Manufacturers will have to make sure to check for the required content in their technical documents according to the classification established for their device.

EMMA International can conduct a gap assessment and can help you transition to the new EU MDR. For additional information, please give us a call at 248-987-4497 or email info@emmainternational.com.


1BSI – Technical Documentation and Medical Device Regulation white paper retrieved on 02/21/2019 from https://www.bsigroup.com/globalassets/localfiles/es-es/Medical%20devices/Documentos%20tecnicos/white-paper-technical-documentation-web.pdf

 

Nikita Angane

Nikita Angane

Solutions Delivery Specialist - Ms. Angane is a Bioengineering graduate with experience in medical device commercialization, product development, quality system compliance and regulatory affairs. Her portfolio includes working on medical devices, combination products, and pharmaceuticals. As a Solutions Delivery Specialist at EMMA International, she offers her expertise to help our clients achieve an effective and sustainable quality system, and develop regulatory strategies for market access and compliance of new products in the US and international markets. Ms. Angane earned a Bachelor of Engineering in Biomedical Engineering from the University of Mumbai, India and an M.S. in Bioengineering from University of Illinois at Chicago.

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