Further on:  "DHFs / D&DFs for Older Products -- Responses to Questions From My Recent Webinar" (see 10/09/2017 blog):

I recently reviewed my response to the above and feel the need to add an important qualifier.  Yes the US DHF / EU D&DPF provide the development history of a device, while the EU Technical File / Design Dossier / Technical Documentation files are primarily a "snapshot" in time, the current description of the device and how it meets the requirements of applicable EU regulations, especially the old EU MDD (Medical Device Directive, especially the Essential Requirements) and now the EU MDR (Medical Device Regulation, especially the General Safety and Performance Requirements).

The point I failed to sufficiently emphasize, and why Design Control / Design and Development Planning is to be addressed in the first place, in the EUs Technical Documentation File (and why it is a focus of a device CGMP compliance inspection by the FDA), is not just for the development history over time (which is also valuable IP), but primarily for design control, i.e, control / evaluation of the changes in the design as it evolves during R&D and prior to Design Transfer for manufacture.  

When Design Control, 21 CFR 820.30 was added as a CGMP requirement in 1996-97, it was emphasized by FDA spokespersons such as Kim Trautman, that it's primary purpose was to control / formalize design changes under a review (2nd party) and verification system, in the previous poorly controlled R&D change control environment.  This was to address the fact the FDA had identified in its post-production device monitoring, that changes to a device under development were often reactive to one problem, and then not fully vetted as to it's positive effect on a problem, but also not evaluating  any possible negative effects, which need to be identified and eliminated.  The DHF / D&DF documents the design process, including such changes, resulting in a safe and effective device, with minimal to no design flaws that could negatively impact a patient / end user.

-- jel@jelincoln.com