At a minimum, the Technical File documentation for most regulatory processes includes a Risk Management Report, Design documentation, and Manufacturing documentation.
Both the FDA and the EU MDR require a design plan along with the supporting documentation, this includes the plan requirements, architecture, verification, and validation. Additionally, for CE marking, notified bodies will require a design manufacturing report along with any manufacturing validation activities to be completed before the certification audit. Finally, the Technical File submitted to the Notified Body must also contain a Clinical Evaluation Report which summarizes the review of data held by the manufacturers, a literature review of the device and/or equivalent devices, and a search from vigilance databases to identify known hazards and risks of using those devices.
Unique Device Identification (UDI)
The UDI is a series of numeric or alphanumeric characters that is created through a globally accepted device identification and coding standard system. It allows the unambiguous identification of a specific medical device on the market, increasing patient safety and helping to optimize patient care by setting up global standards.
In September of 2013, the FDA established a rule stating that a unique device identifier number should be assigned by the device manufacturer to each version or model of a device, and that the unique device identifier should be both in the human-readable format and in AutoID format.
The EU MDR adopted and refined the UDI requirements in 2017, introducing a new concept of the basic UDI-DI, which allows for the grouping of regulated medical devices within EUDAMED, the EU regulatory database for regulated medical devices. Other stipulations differing from FDA include that the UDI on labels and software need to be identical, and that the cleaning process for reusable devices is to be considered within the system.