Looking Good What Is A Technical File

The Technical File is intended to show compliance with the applicable MDDs Medical Device Directives the EU regulatory framework for Medical Devices.

What is a technical file. The Technical File is a dossier required for marketing a medical device in Europe aka. Regardless of a device class or its intended use design or even the safety history of the device the manufacturer must have and keep up-to-date this technical. What is a Technical File.

Some of the requirements can be common across the Directives and Regulations but to give you a good idea of what is required we have used the technical documentation requirements given in Annex VII of the Machinery Directive as an example. Receiving the CE mark. Your technical file or dossier includes detailed information about the design function composition use claims and clinical evaluation of your medical device.

For Class III devices this is called Design Dossier and has a few additional requirements. 78 rows MDR 2017 745 Annex II Medical Device Technical File is a summary. Although STEDs current iteration is still based on a years-old GHTF document the IMDRF has tasked one of its working groups with updating the format but progress has been slow.

It therefore includes the devices design development VV including clinical and performance validation as well as its regulatory status. A general description of the product. The technical documentation represents the entirety of the documents describing a device.

This file must also include maintenance reports and results of installation tests. The term technical documentation or technical file refers to all the documents that a medical device manufacturer has to submit. Basically the Technical File comprises.

They are required for all classes of devices Class I I Measuring I Sterile IIa IIb and III but no two files are the same because the type of device dictates the information included therein. Sometimes a risk assessment to determine which safety and health requirements apply to the product. I will not discuss this point here but you will need to track the versions and the changes so it is important to also include that on your file Approvers reference number.