Design History File

Medical Device and In-vitro Diagnostic Device regulations are changing constantly and are becoming difficult to comply and implement. One major difficulty that the manufacturers are facing is transitioning and complying to these new changes. One of the challenges for manufacturers of devices is to ensure that they have a design history file for their existing products which should comply with the new European Medical Device Regulations and In-Vitro Diagnostic Device Regulation.

A Design History File is a complex document, as it is a collection of records which demonstrates the design of the device through its development cycle. The Design History File (DHF) provides evidence that the device has been developed in accordance with the user requirements and the design plan.

A separate Design History File (DHF) shall be prepared for different device types, unless you manufacture similar versions of the same device and the design remains same, then it can be included in the same Design History File (DHF).

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 Planning- Design and development planning is needed to ensure that the design process is appropriately controlled and that device quality objectives are met. This consists of the design plan and the Design History File (DHF) is developed as per the requirement of this plan. The plans must be consistent with the remainder of the design control requirements.
• Design Input- These identify the physical, biological, mechanical, chemical or any other performance characteristics for developing a medical device. While documenting design inputs it has to be ensured that the user needs are identified and addressed in measurable terms.
• Design Review- This documents the output of the identified design inputs. The final specifications, acceptance criteria’s, plans, drawings and etc. are generated as a result of activities performed against design inputs.
• Design Verification- this stage is for determining that the design outputs have met design inputs using various means possible which may include testing or an inspection or an analysis to provide the required evidence.
• Design and Development Planning- Design and development planning is needed to ensure that the design process is appropriately controlled and that device quality objectives are met. This consists of the design plan and the Design History File (DHF) is developed as per the requirement of this plan. The plans must be consistent with the remainder of the design control requirements.
• Design Validation- this consists of specific procedure and testing conditions to ensure that devices meet the requirement of specific application and intended use. The main aim is to provide evidence that the product meets user requirements. This can include usability studies, stability studies, product validations, etc.
• Design Transfer- this format records all the activities performed for transfer of design output to manufacturing. It shall trace all the documents, plans, drawings, if required training and all other material for successful manufacturing of the product along with the responsible person.
• Design Changes- this consists of documented design change procedure and documents related to design changes that have taken place.

Do you need assistance in creating a Design History file as per the requirement of ISO 13485:2016, EU MDR 2017/745 and EU IVDR 2017/746?? We are glad to help you to create and maintain your Design History File.