Medical device manufacturers must adhere to strict regulatory requirements, and the U.S. Food and Drug Administration’s 21 CFR Part 820 is a crucial set of regulatory guidelines meant to ensure the medical devices are high quality, safe, and effective.

Per 21 CFR Part 820.30, the FDA requires manufacturers of certain Class I and all Class II and III medical devices to follow design control principles to ensure that specified design requirements are met. The design controls are a set of quality control practices and procedures incorporated into the design and development process to help ensure that manufacturers produce safe, effective products that comply with regulations. As part of these regulatory requirements, manufacturers must establish and maintain a medical device design history file (DHF) for each type of device.

The following is an overview of the FDA’s design control and DHF expectations, as well as the role of the technical file/design dossier in European regulatory requirements.

Key Elements of Medical Device Design Control

As defined in 21 CFR 820.30, medical device design control involves the following elements:

• Design and development planning.
• Design input.
• Design output.
• Design review.
• Design verification.
• Design validation, with software validation if applicable.
• Design transfer.
• Design changes.
• DHF, which compiles the documents outlined above.

Design and Development Planning

The manufacturer must maintain design plans, which should describe or reference design and development activities and define responsibility for implementation.

Design Input

The manufacturer must have procedures to ensure that design requirements relating to a medical device are appropriate and address the intended use of the device.

Design Output

The manufacturer must have procedures for defining and documenting design output in terms that allow a sufficient evaluation of conformance to design input requirements.

Design Review

The manufacturer must have procedures that ensure the planning and conducting of official documented reviews of the design results at appropriate stages of the device’s design development.

Design Verification

The manufacturer must have procedures for verifying the medical device design, and verification must confirm that the design output meets the design input requirements. The verification results must be documented in the DHF.

Design Validation

The manufacturer must have procedures for validating the device design under defined operating conditions on initial production units, lots, or batches, or their equivalents. Design validation should include software validation and risk analysis, where appropriate. The validation results must be documented in the DHF.

Design Transfer

The manufacturer must have procedures to ensure the medical device design is translated into production specifications correctly. The design transfer process must assess the completeness and correctness of the production specifications.

Design Changes

The manufacturer must have procedures for identifying, documenting, validating/verifying, reviewing, and approving design changes before their implementation. Design control entails document control and change control in the controlling of design changes.

Design History File

All of the activities described above are documented in the product's DHF. The design history file contents are a compilation of records showing the evolution of the product’s design, describing the product through its development cycle, under design control. It should contain or reference the records necessary to demonstrate that the design was developed in accordance with the approved design plan and the requirements of the FDA's design control (as described above). The manufacturer must maintain a DHF for each type of medical device.

Technical File/Design Dossier

Under the Medical Device Directive (MDD) and for CE-Marking, the European Union has required a technical file (sometimes referred to as technical documentation) or design dossier, a comprehensive description of the device – including design, function, use, etc. – meant to demonstrate compliance with European requirements. The European Medical Device Regulation (MDR), which goes into effect next month, replaces the currently applicable MDD. Per the MDR, medical device companies will still be required to maintain technical documentation on their products, but the term “design dossier" will be dropped.

Resources

1. "CFR - Code of Federal Regulations Title 21," U.S. Food and Drug Administration, current as of April 1, 2020.
2. "Medical Devices, EU Council Directive 93/42/EEC," European Commission.
3. "CE Marking, Manufacturers," European Commission.