“The DHF is mandated by the U.S. FDA, and describes a product through its development cycle, under Design Control, with its output being the DMR (Device Master Record) which defines the product as currently marketed. However, the EU (European Union) under the Medical Device Directive (MDD; EU Council Directive 93/42/EEC) and for CE-Marking, requires a file describing the product at a point in time, i.e., as currently marketed in EU / Common Market countries, similar to the DMR, with elements of the DHF, such as risk management documents, and clinical data. “
This file is either the Technical file or Design Dossier. The article I found about this lists the general make up and requirements in design controls, as well as the requirements for these documents. Generally, the Technical file or Design Dossier (depending on device class) will include:
• General Information / Product Description / EC Authorized Representative
• Classification Determination (Annex IX, Rule [select applicable rule])
• Essential Requirements (Annex I)
• Risk Analysis
• Labeling
• Product Specifications
• Design Control
• Clinical Evaluation (Annex X; literature review, et al.)
• System Test Reports
• Functional Bench Testing
• Lab Testing (cytotox, hemolysis, sensitization, carcinogenicity, other biocompatibility testing)
• Sterilization validation (or AAMI TIR 28 Analysis)
• Packaging Qualifications
• Manufacturing
• Sterilization
• Conclusion
• Declaration of Conformity (Annex II, V, VII)
• Appendix (further supporting information / details on the above).
Source: http://www.mastercontrol.com/newsletter/medical_device/medical-device-design-history-file-0710.html