Design History File (DHF), Technical File and Design Dossier are important regulatory documents for a medical device. Design Control and Design History File are regulatory documents for medical devices in the FDA, while the Technical File and Design Dossier serve the same purpose for the EU’s regulatory body, the MDD.
The Design History File
The history of the Design History File is an interesting one. It evolved out of the FDA’s realization, over time and experience; that the major part of a device’s problems was happening during the design stage and change phases, regardless of whether it was a new product or a changed one. This led to the birth of the concept of Design Control, aimed at tracking, monitoring and correcting the design elements at every stage from start to finish.
Outstanding characteristics of the Design History File
What should the Design History File contain?
The DHF should contain the following:
Now, the Technical File and Design Dossier
In short and simple terms, one can understand the Technical File and the Design Dossier as the EU’s version of the Design Control and the DHF. In other words, what Design Control and Design History File are for the FDA; the Technical File and Medical Device (MDD) are for the Medical Device Directive.
What should the TF and DD contain?
These files should have all the basic sections needed to support the requirements of the Medical Device Directive (MDD), Essential Requirements (for that product), and the company’s “Declaration of Conformity” for that product:
- General Information/Product Description/EC Authorized Representative
- Classification Determination
- Essential Requirements
- Risk Analysis
- Product Specifications
- Design Control
- Clinical Evaluation
- System Test Reports
- Functional Bench Testing
- Lab Testing
- Sterilization validation (or AAMI TIR 28 Analysis)
- Packaging Qualifications
- Declaration of Conformity
Differences between the Technical File and Design Dossier
At a broad level, in general terms, while the Technical File is for MDD Class I and Class II a or II b; the Design Dossier is for MDD Class III devices
While Technical Files are retained in the premises of the manufacturer or the Authorized Representative for review of the Competent Authorities or/and Notified Body; Design Dossiers need to be submitted to the Notified Body for review before the product gets its CE-marking.