Design History File (DHF)

The regulations surrounding Medical Devices and In-vitro Diagnostic Devices are constantly evolving, making compliance increasingly difficult for manufacturers. One significant challenge they face is adapting to and implementing these new regulatory changes. A key area of concern for device manufacturers is ensuring they have an up-to-date Design History File (DHF) for their existing products, which complies with the latest European Medical Device Regulations (MDR) and In-Vitro Diagnostic Device Regulation (IVDR).

A Design History File is a comprehensive document that compiles all records demonstrating the device’s development cycle. It serves as evidence that the device has been created according to user requirements and design specifications.

Manufacturers must prepare a separate Design History File (DHF) for each different type of device. However, if similar versions of the same device are produced, and the design remains unchanged, these versions can be included in a single Design History File (DHF).

This process ensures that the medical device design history file meets the regulatory standards required for market approval. Each medical device design history file must be meticulously maintained to comply with current regulations, ensuring that the design history file medical device remains in line with the latest requirements.

Key Elements of Design History Files

Design and Development Files

Design and Development Changes

Design and Development Transfer

Design and Development Validation

Design and Development Verification

Design and Development Review

Design and Development Output

Design and Development Input

User Needs

Design and Development planning

• Design and Development Files: Design and Development Files play a crucial role in ensuring that medical devices comply with regulatory standards and meet user needs. These files encompass a comprehensive set of documents, including design inputs, design reviews, and validation reports, which confirm that the device is developed following the required guidelines. Properly maintained design history files are essential to demonstrate that the product meets quality and safety requirements throughout its lifecycle. These design history file medical device records provide evidence of the design process, allowing manufacturers to track any design changes or updates. They are vital for regulatory submissions and audits, ensuring that all design and development stages are thoroughly documented.
• Design and Development Changes: This section encompasses a well-documented procedure for managing design changes, along with all relevant documents that detail the modifications made during the design and development phases. These records are critical for maintaining a clear audit trail of changes, ensuring compliance with regulatory requirements. By systematically documenting design changes, you can ensure that all updates are thoroughly reviewed, approved, and incorporated into the design history files. This process not only supports ISO 13485:2016, EU MDR 2017/745, and EU IVDR 2017/746 requirements but also provides valuable insights for future improvements and regulatory audits.
• Design and Development Transfer: This format serves as a comprehensive record of all activities involved in transferring the design output to the manufacturing phase. It includes documentation of all relevant documents, plans, drawings, and any necessary training programs required to facilitate the smooth transition. In addition to outlining the steps for successful manufacturing, it identifies the responsible individuals overseeing each task. The design transfer format ensures that every critical element is properly documented, and all necessary resources are in place to ensure the product’s successful manufacturing while maintaining full compliance with industry standards.
• Design and Development Validation: Design Validation is a critical process that involves a set of specific procedures and testing conditions to ensure that medical devices meet the requirements of their intended application and use. The primary objective is to provide substantial evidence that the product successfully fulfills the needs and expectations of end-users. This process includes a variety of activities such as usability studies, stability studies, product performance validations, and other assessments designed to ensure the device functions as intended in real-world conditions. By thoroughly validating the design, manufacturers can ensure the product’s safety, effectiveness, and reliability in its intended application.
• Design and Development Verification: Design Verification is a critical stage in the product development process, where the objective is to confirm that the design outputs align with and meet the specified design inputs. This step involves using a variety of methods, such as rigorous testing, detailed inspections, or comprehensive analysis, to gather the necessary evidence that verifies the design’s compliance with the intended requirements. Ensuring the accuracy of this phase is essential to guarantee that the final product performs as expected and adheres to all relevant standards and specifications.
• Design and Development Review: This critical document captures the output derived from the identified design inputs. It encompasses a comprehensive collection of the final specifications, acceptance criteria, plans, drawings, and other relevant documentation. These elements are generated as a direct result of various activities and evaluations performed against the design inputs, ensuring that the design aligns with the set requirements and objectives. The design review process is crucial for validating that the design meets all necessary regulatory and functional criteria before moving to the next stages of development and production.
• Design and Development Output: Design and Development Output refers to the final result of the design and development process, encompassing all the documents, specifications, and data that validate the completed design. This output should demonstrate that the device has been designed and developed according to the established requirements, including safety, performance, and regulatory standards. Key elements of the output include finalized design specifications, test results, manufacturing processes, and packaging requirements. It is essential that all outputs are thoroughly reviewed, documented, and traceable to ensure compliance with medical device regulations and to facilitate smooth transition to production and market introduction.
• Design and Development Input: Design inputs are the foundation for developing a medical device, encompassing various characteristics such as physical, biological, mechanical, chemical, and other performance attributes. These inputs play a critical role in shaping the device to meet regulatory standards and user requirements. When documenting design inputs, it is essential to clearly identify and address the needs of the user, ensuring that they are articulated in measurable terms. This guarantees that the device will fulfill its intended purpose effectively and safely, aligning with both user expectations and regulatory requirements for medical devices.
• User Needs: User needs are a crucial component in the design and development of medical devices. These needs refer to the requirements and expectations that users (such as healthcare professionals or patients) have for the device’s functionality, safety, usability, and performance. Identifying user needs early in the design process ensures that the device will effectively address real-world problems and meet the intended purpose. It is important to document these needs in measurable terms, as they serve as a foundation for design inputs, guiding the entire development cycle. A clear understanding of user needs helps in creating a device that is both safe and user-friendly, ultimately ensuring its success in the market.
• Design and Development Planning: Effective design and development planning is essential to ensure that the design process is rigorously controlled and that the quality objectives for the device are achieved. This involves creating a detailed design plan, which outlines the necessary steps, processes, and resources. The Design History File (DHF) is then developed in accordance with the requirements specified in this plan. The design plan and DHF must align with all relevant design control requirements, ensuring compliance with industry standards. It is crucial to maintain comprehensive design history files for your medical device to facilitate streamlined processes and regulatory adherence.

Design History File Checklist

A Design History File (DHF) is essential for demonstrating compliance with regulatory requirements for medical devices. To ensure that your DHF is thorough and meets all necessary standards, a Design History File checklist should be followed. This checklist ensures all aspects of the design and development process are documented, from design inputs and reviews to verification and validation activities. It also includes records of design transfer and changes, providing a clear audit trail of the device’s development. Ensuring that your DHF is complete, up-to-date, and aligned with the latest regulations for medical devices is crucial for maintaining compliance.

Are you looking for assistance in creating a Design History File in accordance with ISO 13485:2016, EU MDR 2017/745, and EU IVDR 2017/746 requirements? Our expert team is ready to help you create and maintain your Design History File. Trust our design history file consultant to ensure full compliance and streamline your medical device documentation process.