The FDA demands that manufacturers adhere to the principles of design control to ensure that the specified design specifications are met.

Medical device makers must comply with strict rules and regulations. The U.S. Food and Drug Administration's 21 CFR Part 820 is an essential set of regulations designed to ensure that medical devices are of the highest quality, secure, safe, and efficient.

As per the 21 CFR Part 820.30 in 21 CFR Part 820.30, the FDA demands that manufacturers of Class I devices and every Class II or III device adhere to guidelines for design control to ensure that the specified specifications for design are fulfilled. Design control is a collection of procedures and practices for quality control integrated into the development and design process to ensure that manufacturers create reliable, safe products that meet the requirements. To comply with the regulatory requirements, manufacturers must establish and keep an electronic medical device Design History File (DHF) for each kind of device.

The following article is a brief overview of FDA's design control regulations and DHF expectations and the importance of the design dossier/technical file in European regulations.

Essential Elements of Medical Device Design Control

According to 21 CFR 820.30, the control of design for medical devices includes the following components:

• Planning for development and design
• Design input
• Design output
• Design review
• Design Verification
• Design validation and software validation if necessary
• Transfer of design
• Design modifications
• DHF is a compilation of the documents previously discussed

Design and Development Planning

The manufacturer must keep track of design plans that must provide a description of or a reference to development and design processes and determine the responsibility for their implementation.

Useful Resources -

• Relationship between FDA QSR 21 CFR 820 and ISO 13485:2016
• What is the Difference between FDA 510k Clearance and Approval?

Design input

The manufacturer must follow procedures to ensure that the requirements for the design of medical devices are in line with the requirements and reflect the intended usage that the equipment is intended for.

Design Output

The manufacturer should be able to define and describe design outputs that permit the proper assessment of the conformity to specifications for inputs to design.

Design Review

The manufacturer must implement procedures to ensure the preparation and conduct of an official review of the design's results during the appropriate phases of the design process.

Design Verification

The manufacturer must establish procedures for evaluating the design of the medical device, and the verification process must verify that the output of the design is in line with the design input requirements. The results of verification must be recorded inside the DHF.

Design Validation

The manufacturer should have procedures to verify the device's design is defined operating conditions for beginning batches, production units’ batches, or equivalents. Design validation should incorporate software and risk analysis, if necessary. The validation results need to be recorded within the DHF.

Design Transfer

The manufacturer should have procedures in place to ensure that the design of the medical device is translated into specifications for production properly. In addition, the design transfer process should verify the completeness and accuracy of the specifications for production.

Designs Changes

The manufacturer must have procedures for identifying, documenting, validating/verifying, reviewing, and approving design changes before their implementation. Design control involves document control and control of changes when it comes to controlling changes to the design.

Design History File

The entire process described above is documented. All of the above activities are documented in the DHF. The contents of the design history file include a collection of information that documents the evolution of the product's design and describes the product throughout its development phase, with the control of the design. It must contain or reference the documents necessary to prove how the product was created according to the approved design plan and the requirements of the FDA's control of design (as described previously). The manufacturer must keep the DHF for every type of medical instrument.

Technical Dossier for Design/File

Following the Medical Device Directive (MDD) and to obtain CE labelling for CE marking, the European Union is required to submit an electronic file (sometimes called a technical document) (also known as a design dossier), which is a complete description of the device -- including functions, design, etc.--meant to demonstrate compliance with European standards. The European Medical Device Regulation (MDR) that is set to take effect next month will replace the current in-force MDD. As per the MDR, medical device manufacturers must maintain documentation regarding their products. However, the phrase "design dossier" is being dropped.

Article source: https://article-realm.com/article/Finance/19734-A-brief-overview-of-Medical-Device-Design-History-File-Technical-File-Design-Dossier.html