The Design History File (DHF), the Technical File (TF) and the Design Dossier (DD)

The Design History File (DHF), the Technical File (TF) and the Design Dossier (DD) are core regulatory documents for a medical device. This is how one can understand the central difference between them: the Design History File (along with Design Control), is the most important among the regulatory documents that the FDA requires for medical devices, while the Technical File and Design Dossier are documents that serve the same purpose, however, within the EU’s regulatory body, the Medical Device Directive (MDD). These documents constitute core regulatory requirements within these regulatory bodies.

The DHF on the one hand, and the TF and the Design Dossier on the other, have a lot of similarities as well as dissimilarities with each other. At a basic level, the major similarity between them is their intended purpose, while what they should contain is the main difference between the two.

If US medical device companies seeking to go global have to compete at a global level, they must meet an assortment of product design documentation standards. The Design Control and the Design History File (DHF) are mandated by the FDA’s CGMPs in 21 CFR 820.30, while for the EU; the core requirement is its CE-marking documentation –the Technical File or Design Dossier, as described in the MDD.

A thorough understanding of Design History File, the Technical File and the Design Dossier is necessary

All the complexities and in-depth clarification relating to these subtle matters about medical device regulatory requirements will be unraveled at a two-day seminar that is being organized by GlobalCompliancePanel, a leading provider of professional trainings for the areas of regulatory compliance. John E Lincoln, who is Principal of J. E. Lincoln and Associates LLC, a consulting company and a senior Consultant in the Medical device and Regulatory Affairs areas, will be the Director at this seminar.

This seminar has been pre-approved by RAPS as eligible for up to 12 credits towards a participant’s RAC recertification upon full completion. To register for this seminar, please log on to http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900746?linkedin-SEO .

Complete knowledge of Design History File, the Technical File and the Design Dossier

At this seminar, Lincoln will examine the existing and proposed requirements for the FDA’s DHF, which includes a discussion of its derivative documents, the DMR and DHR. He will explain what the European Union’s MDD TF/DD requirements are, along with an evaluation of the documents’ differing purposes and goals, their similarities, as well as the two different device classification schemes. All important aspects relating to these areas will be taken up.

These are some of the topics Lincoln will take up for discussion:

o  Areas requiring frequent re-evaluation or update

o  Similarities and differences

o  Future trends

o  Typical DHF Table of Contents

o  Technical File or Design Dossier Table of Contents

o  The importance and usefulness of the “Essential Requirements”

o  Structure of the “Declaration of Conformity”

o  Self-declaring or Notified-Body reviewed

o  Parallel approaches to development

o  The differing approaches to file audits by the U.S. FDA and the EU Notified Body.

Useful session for companies that need to handle Design History File, the Technical File and the Design Dossier

Being a seminar aimed at helping participants understand US and global standards for medical devices; it will offer valuable assistance to all regulated companies that need to implement, review and/or modify their Device History Files, Device Master Records, Device History Records, Technical Files or Design Dossiers, documents, and activities/plan(s).

During the course of these two days, Lincoln will cover the following areas:

o  The Design Control requirements of the CGMPs, 21 CFR 820.30

o  The Design History File – documenting Product Design Control and its nine elements

o  The Device Master Record and the Device History Record

o  The EU’s Medical Device Directive

o  The “Essential Requirements”; and their documentation

o  The remaining elements of a Technical File / Design Dossier

o  Trends

o  Two attendee projects.

What are Design History File Requirements?

What are Design History File Requirements?

The Design History File (DHF) is a critical document for a medical device. The DHF is a record of a series of documents that explain the design history of a medical device. In other words, it is a documentation of the way by which the inputs that went into the medical device manufacture worked in a preset process to arrive at the final product.

DHF requirements are an important component of the DHF. The DHF, a strict requirement from the FDA, is essentially meant to show conformance with design controls as specified under FDA’s 21 CFR 820.30 and Sub-clause 4.4 of ISO 9001. It is there to show that the inputs that were specified for a product were met by the resulting product, and also how it got there under conditions of control, once a start date has been established. In other words, it eventually proves design control elements.

The US FDA states that DHF requirements need to be met. What are these requirements? The purpose of having specified DHF requirements is to ensure that user needs are met. It lists out a series of parameters that need to be met in order to ensure that these DHF requirements were met. These are:

These are the parameters or elements of the DHF requirements that need to be fulfilled:

  • Design planning
  • Design input
  • Design output
  • Design changes
  • Design review(s)
  • Design verification/validation
  • Design transfer
  • Design history file

Contact Detail

webinars@globalcompliancepanel.com
http://www.globalcompliancepanel.com

Phone: 800-447-9407
Fax: 302-288-6884

1000 N West Street | Suite 1200 | Wilmington | DE | USA | 19801

 

Design History File content

Design History File content

The design history file (DHF) is a very important document for a medical device, because it is what may be called the route map for the product’s design. It is proof that the device followed the right method on the way to arriving as the final product.

What is DHF?

It is defined, rather broadly, in ISO 13485 as being the record needed to provide evidence that the realization processes and the resulting product meet their specified requirements. 21 CFR 820.3 (e) of the FDA also describes DHF broadly as a compilation of records which describe the design history of the finished medical device.

Design history file content

Design history file content is described by both the FDA and ISO 13485.

Design history file content according to the FDA

  • General: A few Class I, Class II and Class III devices are listed here. These are the devices for which design controls apply
  • Design and development planning
  • Design input
  • Design output
  • Design review
  • Design verification
  • Design validation
  • Design transfer
  • Design changes
  • Design history file

ISO 13485

According to ISO 13485, design history file content should consist of the following rules:

  • The manufacturer shall establish plans thatdescribe the design and development activities
  • The plans shall identify and describe theinterfaces with different groups or activities thatprovide input to the design and developmentprocess
  • The plans shall be reviewed, updated and, andapproved as design evolves

References:

http://www.ece.mcmaster.ca/~patriciu/QSR.pdf

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm?fr=820.30

Contact Detail

webinars@globalcompliancepanel.com
http://www.globalcompliancepanel.com

Phone: 800-447-9407
Fax: 302-288-6884

1000 N West Street | Suite 1200 | Wilmington | DE | USA | 19801