Online Safety Community

Unravelling the DHF, Technical File and Design Dossier

Design History File (DHF), Technical File and Design Dossier are important regulatory documents for a medical device. Design Control and Design History File are regulatory documents for medical devices in the FDA, while the Technical File and Design Dossier serve the same purpose for the EU's regulatory body, the MDD.

The Design History File

The history of the Design History File is an interesting one. It evolved out of the FDA's realization, over time and experience; that the major part of a device's problems was happening during the design stage and change phases, regardless of whether it was a new product or a changed one. This led to the birth of the concept of Design Control, aimed at tracking, monitoring and correcting the design elements at every stage from start to finish.

cgmpForCombinationProducts

Outstanding characteristics of the Design History File

cgmpForCombinationProducts

What should the Design History File contain?

The DHF should contain the following:

cgmpForCombinationProducts

Now, the Technical File and Design Dossier

In short and simple terms, one can understand the Technical File and the Design Dossier as the EU's version of the Design Control and the DHF. In other words, what Design Control and Design History File are for the FDA; the Technical File and Medical Device (MDD) are for the Medical Device Directive.

What should the TF and DD contain?

These files should have all the basic sections needed to support the requirements of the Medical Device Directive (MDD), Essential Requirements (for that product), and the company's "Declaration of Conformity" for that product:

  • General Information/Product Description/EC Authorized Representative
  • Classification Determination
  • Essential Requirements
  • Risk Analysis
  • Labeling
  • Product Specifications
  • Design Control
  • Clinical Evaluation
  • System Test Reports
  • Functional Bench Testing
  • Lab Testing
  • Sterilization validation (or AAMI TIR 28 Analysis)
  • Packaging Qualifications
  • Manufacturing
  • Sterilization
  • Conclusion
  • Declaration of Conformity
  • Appendix

Differences between the Technical File and Design Dossier

At a broad level, in general terms, while the Technical File is for MDD Class I and Class II a or II b; the Design Dossier is for MDD Class III devices

While Technical Files are retained in the premises of the manufacturer or the Authorized Representative for review of the Competent Authorities or/and Notified Body; Design Dossiers need to be submitted to the Notified Body for review before the product gets its CE-marking.

 

click to continue reading

Views: 38

Comment

You need to be a member of Online Safety Community to add comments!

Join Online Safety Community

Take our poll!

Take our poll!

Latest Activity

Simon Hopes posted a blog post

Speed governor is a technical invention

The popularity of Watt's improved steam engine was rapid, and by 1790 the old Newcomen steam engine was out of sight, and by 1790 there were about 500 steam engines operating in Britain. After less than 100 years or so, by 1868, there were as many as 75,000 steam engines in Britain alone. In 1805, the steam engine in the United States was equipped with cars as a driving force. In 1807, Robert Fulton (1765-1815) of the United States invented a steamship powered by a steam engine. In 1825 George…See More
yesterday
HrishikeshRam posted blog posts
yesterday
Russel Stuart posted a blog post

HR Documentation is a Vital Aspect of Organizations

HR documentation is of vital importance to organizations. Unless its nuances are mastered organizations can fall into embarrassing and damaging pitfalls.HR documentation is one of the most important aspects at the workplace. The habit of HR documentation is usually imbibed into HR professionals from early on in their careers. But what does HR document?HR documentation resonates with the spirit of the dictum, Verba volant, Scripta manent, meaning "what is written stands; what is uttered flies".…See More
Friday
Laticia Gibson posted a blog post

Searching A Best Dental Clinic Is Important

Keeping a perfect oral health is crucial. Though, in keeping good teeth set, always it has been a must to research for the good General Dental office you can find in your nearby area. It has to be noted that searching the most suitable clinic can confirm you of good quality and pleasing services. Earlier than you make a selection, there are some important things you have to know.The Crucial Things to…See More
Friday

Forum

Road Safety

What can be the best measures for Road Safety?Continue

Started by Jen McDade Sep 27.

safety equipments in breweries 4 Replies

safety equipments in breweries -- kindly provide detailsContinue

Started by ajit. Last reply by Jen McDade Sep 24.

Unusual Safety Tips 10 Replies

Please share some unusual but genuine safety precautions.My unusual safety tips - Don't drink sweet fruity juice while driving in the night as it contains sugar and sugar slows down your blood…Continue

Started by Arnold Brame. Last reply by Jen McDade Sep 24.

Safety products 9 Replies

While working or at some work stations, employees are exposed to threats or at times suffer severe injuries. The safety of the employee should be the foremost priority. Safety equipment aids help in…Continue

Tags: equipments, and, products

Started by Enna Henry. Last reply by Jen McDade Sep 24.

Talend Application Integration

APPLICATION INTEGRATION:Talend ESB and Application Integration delivers agile real-time integration of applications and data.Heterogeneous Application and Data IntegrationTalend’s open source ESB…Continue

Tags: york, new, certification, training, talend

Started by nicolewells Sep 21.

Badge

Loading…

© 2018   Created by Safety Community.   Powered by

Badges  |  Report an Issue  |  Terms of Service