Step 5: Compile the technical documentation

A lot of information will have been produced in the previous steps. That information needs to be organised and presented in a way that demonstrates, if the device is approved; (a) it will conform to the EU’s technical requirements, (b) it will achieve its intended medical purpose and be safe to use, and (c) that proper processes were followed to generate the information which supports the approval.

Start by compiling a checklist of the “Technical Documentation” listed Annex II and Annex III. Most of the documentation listed will already have been generated during steps 1 to 4. However, a few additional items will be required to complete the documentation:

The "Unique Device Identifier" or UDI is one example of additional information which will be needed to complete the documentation. UDI is a barcode system that will enable IVD devices to be tracked wherever they are distributed in the EU. At the time of writing this article the EU has yet to finalise the precise details of the UDI system. But the system is described in Article 24 and Part C of Annex VI.

If your IVD is going to be a in one of the higher risk classes, C or D, you will also need to develop an additional summary of safety and performance for uploading to the European registration database (See Article 29).