A concept similar to the FDA’s Design History Files, the EU Technical File is a collection of documents related to the design and development of a product, the product’s intended use, and the other documents containing relevant information to the product. These documents are required by the EU in order to demonstrate conformity with EU regulations, in the case of medical devices the EU MDR 2017/745. This again is similar to the Design History File required by the FDA. Both the Technical File and the Design History File act as a high-level overview of the product. Yet, there can often be some confusion about which documents are needed in the Technical File.
The EU MDR 2017/745 does outline the minimum requirements for a Technical File, however, simply meeting those requirements will likely not be enough to get approval for a product. There are a few key sections that need to be included in the Technical File. One of which is a section on General Safety and Performance Requirements. This section should demonstrate how the product meets those requirements. The EU MDR 2017/745 has updated the previous requirements set in the EU MDD meaning that when the technical file is being made the updates need to be taken into account.
Of course, the Device Description and specifications need to be in the file as well. Within the description there needs to be a reference to the device’s Unique Device Identification. The device classification should also be included in this section. It is important to remember that while both the US and the EU have Classes I, II, and III the requirements for each class are different between the two markets. It is important to pay attention to those requirements as a device that is one class in the US may not be the same class in the EU.
Creating a Technical File that meets all the requirements set by the EU in the new regulation is a challenge. There is the need to meet the requirements as much as possible as failing to do so will mean that the device will not get approved for market. Thankfully, EMMA International’s team of experts is able to help. Whether it is helping from the start of the design and development of a product or performing a gap analysis after the design and development is already completed, EMMA International can help at any point. EMMA International provides Full Circle Consulting services, give us a call at 248-987-4497 or email us at firstname.lastname@example.org to get in touch with our team of experts today.