This webinar examines the existing and proposed requirements for the U.S. FDA’s Design History File (DHF) and the EU MDR’s Technical Documentation — how to meet and document them, their differing purposes and goals, their required and desirable contents, and the areas that require frequent re-evaluation. It covers similarities and differences, future convergences and trends, a typical DHF table of contents (including Risk Management and Use Engineering), and a Technical Documentation File table of contents.

Global companies must meet different product-design documentation requirements for the U.S. and the European Union. The cGMPs mandate Design Control and the DHF; ISO 13485 requires the Design and Development File; and both require a Risk Management File (ISO 14971) and a Use Engineering File (IEC 62366-1). To sell globally, the EU’s CE-marking documentation — formerly the MDD Technical File or Design Dossier, now the MDR Technical Documentation File — is required.

Currently these files serve different purposes and support different goals, but the Technical Documentation is moving in the direction of the DHF, and the DHF may soon borrow features required in the MDR’s file. The session also explains the importance of the “Essential Requirements,” the structure of the Declaration of Conformity (self-declared or Notified-Body reviewed), parallel approaches to development, the relationship of the Device Master Record (DMR) and Device History Record (DHR) to the DHF and Technical File, and the differing approaches to file audits by the U.S. FDA and a Notified Body.

Webinar takeaway:

• The U.S. FDA’s DHF
• The EU’s MDR and the Technical Documentation File
• Design Control vs. a product “snapshot in time”
• DHF / D&DF required contents
• The Risk Management File (ISO 14971)
• The Use Engineering File (IEC 62366-1)
• Technical Documentation expected contents
• Parallel approaches to documentation — teams
• The DMR and DHR; future directions; FDA and Notified Body audit focus

After this webinar, attendees will be able to answer -

• What are the U.S. FDA and EU MDR requirements for DHFs, DMRs, DHRs, and Technical Documents?
• How do the DHF and the MDR Technical Documentation differ in purpose, and where are they converging?
• What are the required and desirable contents of the DHF / Design and Development File?
• How do the Risk Management File (ISO 14971) and Use Engineering File (IEC 62366-1) fit into the documentation?
• How do the DMR and DHR relate to the DHF and Technical File?
• How do file audits differ between the U.S. FDA and a Notified Body?

This webinar benefits the following agencies -

The session is built around U.S. FDA Design Control and DHF requirements and the EU MDR Technical Documentation, referencing ISO 13485, ISO 14971, and IEC 62366-1. It is relevant to organizations developing medical devices and combination products for the U.S. and CE-marking markets.

Who should attend?

This webinar benefits professionals involved in U.S. FDA-regulated and CE-marking environments, including:

• Senior Management
• Regulatory Affairs (RA)
• Quality Assurance (QA)
• Production
• R&D and Engineering
• All personnel involved in new device / combination product development, line extensions, and product improvements