Producing effective Technical Documentation provides manufacturers with their own central information source regarding their medical device. Accurate Technical Documentation can also reduce the review time spent by notified bodies and make an auditor’s job significantly easier.
Given that Technical Documentation requirements under the Medical Device Regulation (EU) 2017/745 (EU MDR) are more extensive than under the Medical Device Directive (MDD), we have produced an easy-to-read fact sheet that provides 8 useful tips on how to produce effective MDR Technical Documentation, to help facilitate a smooth journey toward the delivery and registration of your medical device.
You can access the fact sheet below by clicking on the “Download” button. And for more resources in the Regulatory field, take a look here.