This is an interesting question! I agree with most of the participants that depending on the device classification, EU regulatory looks at the device development in the Tech File. While, in the US, Design Controls such as DHF and DMR are required by the notified bodies such as FDA. It is beneficial for the medical device companies in the US markets to have records such as DMR and DHRs as part of the design controls because it contains the history of how exactly the product or lot was manufactured. These records are very useful in the event of the investigation required as part of the product recall. On the other hand, in the EU market, Tech files are also useful, but it will be very hard and time consuming to exactly identify the root cause of the issues as there is no traceability at each step. All in all, both philosophies has design controls, however in the US market there are more stringent requirements for the medical device industry.